Philadelphia panel evidence-based clinical practice guidelines on selected rehabilitation interventions for low back pain. (Special Issue).

INTRODUCTION

Low back pain (LBP) is the largest cause of workers' compensation in the United States and Canada. Sixty to 90% of the adult population is at risk of developing LBP at some point in their lifetime. (1-4) Of those who develop acute LBP, 30% develop chronic LBP. (5) Low back pain has a significant impact on functional ability, restricting occupational activities with marked socioeconomic repercussions. (6,7)

A number of different practitioners treat people with LBP. These include physicians, physical therapists, chiropractors, massage therapists, psychologists, kinesiologists, rehabilitation technicians, and others. The treatment goals are to relieve pain, reduce muscle spasm, improve range of motion (ROM) and strength, correct postural problems, and ultimately improve functional status.

A number of rehabilitation interventions are used in the management of people with LBP. Among current musculoskeletal interventions specific for LBP available to rehabilitation specialists, there are body mechanics and ergonomics training, posture awareness training, strengthening exercises, stretching exercises, activities of daily living (ADL) training, organized functional training programs, therapeutic massage, joint mobilizations and manipulations, mechanical traction, biofeedback, electrical muscle stimulation, transcutaneous electrical nerve stimulation (TENS), athermal modalities, cryotherapy, deep thermal modalities, superficial thermal modalities, and work hardening. (8)

The Philadelphia Panel (see article titled "Evidence-Based Clinical Practice Guidelines on Selected Rehabilitation Interventions: Overview and Methodology") was convened to evaluate 9 selected rehabilitation interventions for LBP: thermotherapy, therapeutic massage, therapeutic exercises, electromyographic (EMG) biofeedback, mechanical traction, ultrasound, TENS, electrical stimulation, and combined rehabilitation interventions.

The purpose of this article is to describe the evidence-based clinical practice guidelines (EBCPGs) developed by the panel about rehabilitation interventions for LBP. The aim of developing the guidelines was to improve appropriate use of rehabilitation interventions for low back pain. The target users of these guidelines are physical therapists, physiatrists, orthopedic surgeons, rheumatologists, family physicians, and neurologists.

METHODS

The detailed methods of the EBCPGs development process are summarized in an accompanying article in this issue ("Evidence-Based Clinical Practice Guidelines on Selected Rehabilitation Interventions: Overview and Methodology"). Briefly, an a priori protocol was defined that was followed for the conduct of separate systematic reviews for each intervention.

Studies were eligible if they were randomized controlled trials (RCTs), nonrandomized controlled clinical trials (CCTs), or case control or cohort studies that evaluated the intervention of interest in a population with nonspecific LBP. Nonspecific LBP was defined as pain between the gluteal fold and the uppermost lumbar vertebrae and included postsurgery back pain. The outcomes of interest were functional status, pain, ability to work, patient global improvement, patient satisfaction, and quality of life. The interventions included massage, thermal therapy (hot or cold packs), electrical stimulation, EMG biofeedback, TENS, therapeutic ultrasound, therapeutic exercises, and combinations of these rehabilitation interventions. Studies whose control groups received "active" treatments were included. Concurrent treatments (eg, home exercises, educational booklets, advice on posture) were allowed if they were given in the same way to both the experimental and control groups. However, concurrent therapy that was given to one group but not to the other group was not accepted (eg, education by means of lectures for the control group were not accepted). No limitations based on methodological quality were imposed. Only English-, French-, and Spanish-language articles were accepted. Abstracts were not included.

A structured literature search was developed based on the sensitive search strategy for RCTs recommended by the Cochrane Collaboration (9) and modifications proposed by Haynes et al. (10) The search strategy was expanded to identify case control, cohort, and nonrandomized studies. The search was conducted in the electronic databases of MEDLINE, EMBASE, Current Contents, CINAHL, and the Cochrane Controlled Trials Register up to July 1, 2000. In addition, the registries of the Cochrane Field of Rehabilitation and Related Therapies and the Cochrane Musculoskeletal Group and the Physiotherapy Evidence Database (PEDro) were searched. The references of all included trials were searched for relevant studies. Content experts were contacted for additional studies.

Two independent reviewers (VAR, JP) appraised the titles and abstracts of the literature search, using a checklist with the a priori defined selection criteria. Relevant studies were retrieved and the full articles were assessed by 2 independent reviewers for inclusion. Data were extracted by 2 independent reviewers from included articles, using predetermined extraction forms regarding the population characteristics, details of the interventions, trial design, allocation concealment, and outcomes. Methodological quality was assessed by a 5-point validated scale that assigns 2 points each for randomization and double-blinding and 1 point for description of withdrawals. (11-12) Differences in data extraction and quality assessment were resolved by consensus.

Data were analyzed at 3 approximate time points post-therapy: 1 month, 6 months, and 12 months. If outcomes were reported at different intervals, the closest time was used for these time points.

Because prognosis is widely thought to be dependent on disease duration, the analysis was conducted for 3 categories of LBP: acute (< 4 weeks duration), subacute (4-12 weeks duration), and chronic (> 12 weeks duration). If the population contained individuals with mixed acute and chronic disease durations, the study was excluded. If the population included individuals with mixed subacute and chronic disease durations, the study was classified as chronic.

STATISTICAL ANALYSIS

Data were analyzed using the Review Manager (RevMan) computer program, Version 4.1 for Windows. * Continuous data were analyzed using weighted mean differences (WMDs) between the treatment and control groups at the end of the study, where the weight is the inverse of the variance. Where an outcome was measured with different scales (eg, pain, functional status), the data were analyzed with standardized mean differences, calculated using the mean and standard deviation. Dichotomous data were analyzed using relative risks. Heterogeneity was tested using the chi-square statistic. When heterogeneity was not significant, fixed-effects models were used. With significant heterogeneity, random-effects models were used.

To calculate clinical improvement (defined as 15% improvement relative to a control), the absolute benefit and the relative difference in the change from baseline were calculated. Absolute benefit was calculated as the improvement in the treatment group less the improvement in the control group, in the original units. Relative difference in the change from baseline was calculated as the absolute benefit divided by the baseline mean (weighted for the treatment and control groups). For dichotomous data, the relative percentage of improvement was calculated as the difference in the percentage of improvement between the treatment and control groups.

The recommendations were graded by their level of evidence (I or II) and by the strength of evidence (A, B, or C). This grading system is shown in Table 1 and is described more fully elsewhere (see article titled "Evidence-Based Clinical Practice Guidelines on Selected Rehabilitation Interventions: Overview and Methodology"). Briefly, grade A recommendations indicate that a clinically important benefit was shown in one or more RCTs. Grade B recommendations were assigned for interventions with a clinically important benefit shown in nonrandomized trials. Because there is less confidence in the results of nonrandomized studies, grade B recommendations required that the study be assigned a quality score of 3 or more out of 5. Grade C recommendations were assigned to interventions that have been compared with a control and have shown no evidence of effect in controlled trials. A master grid showing each rehabilitation intervention assessed and the strength and level of evidence is shown in Table 2. The report follows the same order as this grid, from left to right, top to bottom.

Clinically important benefit was shown for therapeutic exercise across subacute, chronic, and postoperative LBP as well as for the continuation of normal activities (Tab. 3). No clinically important benefit was demonstrated for 4 other interventions (Tab. 4). Insufficient data were available for 4 interventions (Tab. 5). The Philadelphia Panel guidelines are compared with other published guidelines in Appendix 1.

A survey questionnaire was sent to 324 practitioners for feedback on the 4 grade A or B recommendations. Their comments were reviewed by the Philadelphia Panel and were incorporated in this EBCPG document.

RESULTS

Literature Search

The literature search identified 4,981 articles related to LBP. Of these, 340 were considered potentially relevant based on the selection criteria checklist. Of these, 41 met the selection criteria and were included (Appendix 2). The number of included trials is shown for each of the interventions for nonspecific back pain in the "cityscape" shown in Figure 1.

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Practitioner Feedback Survey

Of the 324 practitioners surveyed from the American Academy of Family Physicians (AAFP), American Academy of Orthopaedic Surgeons (AAOS), American College of Physicians (ACP), American Physical Therapy Association (APTA), American College of Rheumatology Health Professionals (ARHP), and Physiatric Association of Spine, Sports, and Occupational Rehabilitation (PASSOR), 9 were inappropriately sampled (wrong specialty) and 21 could not be reached due to incorrect addresses. Of the 294 practitioners who were appropriately sampled and received the questionnaire, 149 responded (51% response rate). Of these, 11 (4%) refused to participate and 138 (47%) completed the survey.

ACUTE LBP (< 4 WEEKS)

Therapeutic Exercises for Acute LBP (< 4 Weeks), Level I (RCT), Grade C for Pain, Function, and Return to Work (No Benefit Demonstrated)

Summary of Trials: Four RCTs (N = 1,035) of acute LBP with a control group were included. (13-16) One RCT was excluded due to active intervention in the control group, consisting of specific instructions on back care and biomechanics as well as pelvic tilt exercises not provided to the flexion exercise group. (17) One RCT of endurance training of the trunk muscles was excluded because the population included a mix of subjects with acute and subacute LBP, with pain duration ranging from 1 to 7 weeks. (18) One RCT [dagger] was excluded because the exercise groups also received an educational booklet on posture, which was not given to the control group).

In the included RCTs, the exercises included McKenzie, back extension, Kendall flexion, and strengthening exercises (described in Appendix 2). The treatment schedule ranged from 1 to 3 sessions per week for 4 to 8 weeks.

Efficacy: None demonstrated. Therapeutic exercises were no better than control therapy at improving function, ability to work, or reducing pain at 1 or 12 months. The pooled estimates at 1 month were not clinically important for pain (Fig. 2), function, or return to work. There was no difference in effect between types of exercise (McKenzie, Kendall, or strengthening). At 12 months after the start of therapy, there was no clinically important benefit on pain compared with untreated patients (13,19) and no effect on sick leave days in I year (WMD=3 days, 95% confidence interval [CI] = -22 to 28 days). (16)

[FIGURE 2 OMITTED]

Strength of Published Evidence in Comparison With Other Guidelines: The Philadelphia Panel found level 1 (RCT) evidence that showed no clinically important benefit of stretching (including McKenzie and Kendall programs) or strengthening exercises (level 1, grade C).

This is consistent with the Quebec Task Force on Spinal Disorders (QTF) (20) and the Agency for Health Care Policy and Research (AHCPR), (21) which found no scientific evidence for general exercises.

Clinical Recommendations Compared With Other Guidelines: The Philadelphia Panel recommended there is poor evidence to include or exclude stretching or strengthening exercises alone (grade C for pain, function, and return to work) as an intervention for acute LBP. This recommendation agrees with the AHCPR (21) and BMJ (22) guidelines. In contrast, the QTF (20) recommended the prescription of general exercises as an option to increase strength, ROM, and endurance but did not discriminate between different types of exercise. The BMJ (22) reported that increased stress from therapeutic exercises may be harmful in acute conditions based on the RCT by Malmivaara et al (15) that was included in our study.

Continuation of Normal Activities Versus Enforced Bed Rest for Acute LBP (< 4 Weeks), Level I (RCT), Grade A for Return to Work (Clinically Important Benefit), Grade C for Pain and Function (No Benefit Demonstrated)

Summary of Trials: One RCT (N=186) (15) of continuing normal activities versus 2 days of enforced bed rest was included.

Efficacy: Clinically important benefit was found for return to work. Continuation of normal activities resulted in 49% fewer sick days after 3 weeks relative to the enforced bed rest group, with an absolute difference of 3.4 sick days (95% CI=1.6-5.2 days) (Tab. 6, Fig. 3). The relative change with continuing normal activities was 10% better for functional status (Fig. 4) and 5% lower for pain relative to bed rest (Fig. 5). After 3 months, the normal activities group had 51% fewer sick days (4.5 days less, 95% CI=3-6 days), better function by 10% on the Oswestry scale, and 5% less pain on a 10-cm visual analog scale (VAS).

[FIGURES 3-5 OMITTED]

Strength of Published Evidence in Comparison With Other Guidelines: The Philadelphia Panel found good scientific evidence (level I) of important clinical benefit of functional activities on return to work, similar to the AHCPR (21) evidence rating. The QTF (20) found no scientific evidence for general exercises but did not evaluate continuation of normal activities as a separate intervention.

Clinical Recommendations Compared With Other Guidelines: The Philadelphia Panel concluded that there is good evidence to include continuation of normal activities (grade A for return to work, grade C for pain and function) as an intervention for people with acute LBP. This conclusion agrees with the AHCPR (21) guidelines. The BMJ (22) guidelines do not discuss normal activities as an intervention. The QTF (20) did not discriminate between normal activities and stretching and strengthening programs.

Practitioner Agreement

* Response rate for this EBCPG: 46%

* Percentage of practitioners giving comments for this EBCPG: 41%

* Agree with recommendation: 98%

* Think a majority of my colleagues would agree: 98%

* Will (or already) follow this recommendation: 98%

Practitioner Comments

1. Guideline should differentiate acute herniated disk, which may benefit from bed rest.

2. Amount of bed rest is important--more than 72 hours is unnecessary.

Panel's Response: The trial on which this recommendation is based excluded patients with disk involvement; therefore, the effects of continuing normal activity in patients with acute herniated disk involvement cannot be assessed. The Philadelphia Panel did not assess whether bed rest is an effective therapy for patients with acute LBP, but a Cochrane review on bed rest has just been completed. The results suggest that 2 to 7 days of bed rest has no effect on pain or functional status in patients with acute LBP and that there is no difference between short (2 days) or long (7 days) bed rest. (23)

Mechanical Traction for Acute LBP (< 4 Weeks), Level I (RCT), Grade C for Pain and Patient Global Assessment (No Benefit Demonstrated)

Summary of Trials: Three RCTs (N=176) of intermittent mechanical traction versus placebo for acute LBP were included. (24-26) One RCT (N=16) compared vertical traction with bed rest. (27) Disease duration was not well reported, but all patients were hospitalized. All trials included patients with back pain radiating below the knee.

Efficacy: None demonstrated. For intermittent traction, there was no difference at I month between traction and placebo for number of patients with improved pain (relative risk [RR]=0.88, 95% CI=0.50-1.55) (Fig. 6) or pain (-3.4 mm on a 100-mm VAS, 95% CI = -21.2 to 14.5) (Fig. 7). For vertical traction at 1 month, there was no difference in pain (0.1 cm on a 10-cm VAS, 95% CI = -2.6 to 2.8) or patient global improvement (RR=I.14, 95% CI=0.88-1.49). No data were reported beyond I month.

[FIGURES 6-7 OMITTED]

Strength of Published Evidence in Comparison With Other Guidelines: We found level I (RCT) evidence of no clinically important benefit of traction for acute LBP. In contrast, the QTF (20) found no scientific evidence, and the AHCPR (21) found moderate scientific evidence of lack of benefit. The AHCPR (21) included the same trials except for one, used a different classification of the evidence, and included a trial involving clients with chronic LBP conditions.

Clinical Recommendations Compared With Other Guidelines: The Philadelphia Panel recommends that there is poor evidence to include or exclude mechanical traction alone (grade C for pain and patient global assessment) as an intervention for acute LBP. This recommendation is in accord with AHCPR (21) and BMJ (22) clinical recommendations compared with other guidelines. In contrast, the QTF (20) recommended mechanical traction as an option to increase ROM. The BMJ (22) reported potential harms, not validated in trials, including: (1) debilitation, (2) loss of muscle tone, (3) bone demineralization, and (4) thrombophlebitis.

Therapeutic Ultrasound for Acute LBP (< 4 Weeks), Level II (CCT), Grade C for Pain (No Benefit Demonstrated)

Summary of Evidence: One nonrandomized controlled trial (N=73) of continuous ultrasound versus placebo was included. (28)

Efficacy: None demonstrated. There was no difference between continuous ultrasound and no treatment for pain improvement (Fig. 8). However, range of flexion and extension was improved after I month by 28 degrees (95% CI=26 [degrees]-29 [degrees]). (28) No data were available for functional status, strength, quality of life, or return to work at 1 month, and no data were available beyond 1 month.

[FIGURE 8 OMITTED]

Strength of Published Evidence in Comparison With Other Guidelines: We found level II scientific evidence that therapeutic ultrasound has no clinically important benefit. This finding agrees with the AHCPR (21) rating. In contrast, the QTF (20) found no scientific evidence.

Clinical Recommendations Compared With Other Guidelines: The Philadelphia Panel recommends that there is poor evidence to include or exclude therapeutic ultrasound alone (grade C for pain) as an intervention for acute LBP. This EBCPG agrees with AHCPR (21) and BMJ (22) guidelines, even though they make general statements to consider physical interventions, including therapeutic ultrasound. In contrast, the QTF (20) recommended therapeutic ultrasound as an option to diminish muscle spasm and relieve symptomatic pain. However, ultrasound was classified as thermotherapy, which is misleading, because pulsed ultrasound does not produce thermal effects. There is insufficient information regarding adverse effects. (22)

TENS for Acute LBP (< 4 Weeks), Level I (RCT), Grade C for Pain or Function (No Benefit Demonstrated)

Summary of Trials: One RCT (N=58) compared TENS and placebo for the management of people with acute LBP. (29) All patients were treated with mobility and strengthening exercises. The TENS consisted of 15 minutes of high-frequency TENS followed by 15 minutes of acupuncture-like TENS.

Efficacy: None demonstrated. There was no difference in self-rated VAS pain (Fig. 9), functional status, strength, or ROM at 1 month. (29)

[FIGURE 9 OMITTED]

Strength of Published Evidence in Comparison With Other Guidelines: We found level I evidence of no clinically important benefit of. TENS on pain or function, similar to the AHCPR, (21) which found limited research-based evidence. The AHCPR, (21) however, included one study that we rejected because the intervention used was electroacupuncture, not TENS. In contrast, the QTF (20) found no scientific evidence for TENS in acute LBP.

Clinical Recommendations Compared With Other Guidelines: The Philadelphia Panel recommends that there is poor evidence to include or exclude TENS alone (grade C for pain) as an intervention for acute LBP. This EBCPG agrees with the AHCPR (21) and BMJ (22) recommendations. In contrast, the QTF (20) recommended TENS as a useful modality for symptomatic pain relief, but this may refer to electroanalgesia rather than TENS specifically. Insufficient information is available regarding adverse effects. (22)

Interventions With Insufficient Data for Acute LBP (< 4 Weeks)

No evidence with acceptable research design, interventions, group comparisons, and outcomes were identified for thermotherapy, electrical stimulation, therapeutic massage, or EMG biofeedback. This lack of evidence concurs with both the QTF (20) and AHCPR (21) guidelines. However, the QTF (20) recommended thermotherapy, massage, and EMG biofeedback as potential interventions for acute LBP.

Some trials of combinations of rehabilitation interventions for acute LBP were identified, but these trials were excluded due to poor definitions of the interventions, populations, or nonstandard outcomes. The Philadelphia Panel rated the evidence as insufficient for a recommendation. In contrast, both QTF (20) and BMJ (22) recommended that rehabilitation specialists use physical interventions at their own discretion to relieve spasm; reduce inflammation and pain; increase strength, ROM, and endurance; and improve functional status.

SUBACUTE LBP (4-12 Weeks)

Therapeutic Exercises for Subacute LBP (4-12 Weeks), Level I (RCT), Grade A for Pain, Function, and Patient Global Assessment (Clinically Important Benefit)

Summary of Trials: Three RCTs (N=405) of therapeutic exercises versus a control were included. (30-32) The exercises consisted of McKenzie, Kendall, and strengthening exercises (described in Appendix 2). The treatment schedule was twice per week for 4 weeks.

Efficacy: Clinically important benefit on pain relief and patient-assessed global condition was demonstrated by meta-analysis. Therapeutic exercises provided more pain relief relative to the control by 10% for strengthening exercises alone, (30) 11% for Kendall flexion, (32) 50% for McKenzie exercises, (32) and 57% for McKenzie exercises (31) after 1 month (P < .05) (Tab. 7). Functional status was improved relative to the control by 11% with McKenzie exercises (31) and 15% with strengthening exercises (30) (Fig. 10). Patient global improvement was 17% to 24% better with Kendall exercises relative to the control, but not statistically different (32) (Tab. 8). We could not assess the use of these interventions in patients with neurological or radicular pain, as these diagnostic groups were excluded from the original trials.

Strength of Published Evidence in Comparison With Other Guidelines: There is level I evidence of clinically important benefit on pain relief and patient global assessment with therapeutic exercises consisting of extension, flexion, or strengthening exercises as therapy for subacute nonspecific LBP (level I). This disagrees with the QTF, (20) which found no scientific evidence for general exercises, but 2 RCTs (30,31) have been published since the QTF, which explains this difference. The AHCPR (21) included 3 additional trials compared with our research team: a trial with clients with chronic LBP conditions, another with a psychological intervention, and another involving a back school approach.

Clinical Recommendations Compared With Other Guidelines: The Philadelphia Panel recommends that there is good evidence to include extension, flexion, and strengthening exercises as interventions for subacute LBP (grade A for pain, function, and patient global assessment). However, we did not assess the use of these interventions for patients with neurological or radicular pain, as these diagnostic groups were excluded from the original trials. This is in partial concordance with AHCPR, (21) which recommended low-stress aerobic exercises within the first 4 weeks (acute LBP). The BMJ (22) is also in agreement with our EBCPG concerning extension, flexion, and strengthening exercises. The QTF (20) recommended the prescription of general exercises as an option to increase strength, ROM, and endurance. The BMJ reported that the increased stress of therapeutic exercise is potentially harmful in subacute conditions.

Practitioner Agreement

* Response rate for this EBCPG: 49%

* Percentage of practitioners giving comments for this EBCPG: 32%

* Agree with recommendation: 90%

* Think a majority of my colleagues would agree: 88%

* Will (or already) follow this recommendation: 93%

Practitioner Comments

1. Selection of exercises depends on clinical presentation; if there are neurological or sensory deficits, exercises could exacerbate the pain.

2. Type of exercise (eg, Kendall, McKenzie) depends on patient.

3. A combined approach with education is needed.

4. Length of follow-up in Davies et al study (32) is insufficient.

Panel's Response: The guideline has been modified to specify that we did not assess the use of these interventions for patients with neurological/radicular pain. The individualized approach to exercise prescription is a widespread clinical opinion but has little empiric evidence. The effects of individualized approaches could not be assessed, because the trials report group outcomes. Education was not assessed by the Philadelphia Panel. An educational booklet on posture and biomechanics was provided to the patients in both groups of 1 trial, (31) but not to the other 2 trials. When the Davies et al study (32) was excluded from the analysis, the results remained the same; therefore, exclusion of this study would not change the recommendation.

Mechanical Traction far Subacute LBP (4-12 Weeks), Level 1 (RCT), Grade C for Patient Global Assessment and Return to Work (No Benefit Demonstrated)

Summary of Trials: Two RCTs (N=212) of static traction compared with a placebo were included. (33,34) One trial was excluded due to lack of a control group (traction was compared with heat). (35) Both trials included patients with radiating pain.

Efficacy: None demonstrated. There was no clinically important benefit for patient global assessment at 1 month (Fig. 11) or for return to work at 12 months (Fig. 12). (34)

[FIGURES 11-12 OMITTED]

Strength of Published Evidence in Comparison With Other Guidelines: The Philadelphia Panel found level I evidence of no clinically important benefit of mechanical traction for subacute LBP. In contrast, the AHCPR (21) found moderate scientific evidence of no benefit, and the QTF (20) reported no scientific evidence. The AHCPR (21) included the same trials as our research team except for one, did not use the same classification for scientific evidence, and included a trial involving clients with chronic LBP conditions.

Clinical Recommendations Compared With Other Guidelines: The Philadelphia Panel recommends that there is poor evidence to include or exclude mechanical traction alone (grade C for patient global assessment and return to work) as an intervention for subacute LBP. This EBCPG agrees with AHCPR (21) and BMJ (22) recommendations. The QTF (20) recommended mechanical traction as an option to increase ROM. The BMJ (22) reported the following potential harms of traction: (1) debilitation, (2) loss of muscle tone, (3) bone demineralization, and (4) thrombophlebitis.

CHRONIC LBP (> 12 WEEKS)

Therapeutic Exercises for Chronic LBP (> 12. Weeks), Level I (RCT), Grade A for Pain and Function (Clinically Important Benefit), Grade C for Return to Work (No Benefit Demonstrated)

Summary of Trials: Seven trials were excluded due to lack of an appropriate control group. (36-42) One study could not be analyzed because standard deviations were not reported. (43) Eight RCTs were included. (44-51) The exercises included flexion, extension, (44) stretching, circuit training, (45,49,50) and strength exercises with progressive increases in resistance. (46-48)

Efficacy: Clinically important benefit was demonstrated for pain relief and functional status. Five RCTs (N=361) demonstrated percentage reductions in pain relative to the control group of 7%, (50) 20% (44) 23%, (45) 26%, (46) and 60% (47) (Tab. 9, Fig. 13). Two RCTs of nursing aides with back pain showed no difference in number of patients with pain improvement after 1 month (RR= 1.45, 95% CI=0.59-3.56). (48,49) Functional status was improved in 3 RCTs (N=209) relative to the control group by 7% with stretching exercises (50); 17% with strengthening, stretching, and aerobics (45); and 47% with strengthening exercises (46) (Tab. 10). The pooled meta-analysis results were statistically significant for function (standardized mean difference [SMD]=0.36, 95% CI=0.10.6). There was no difference in ROM, strength, or return to work. One RCT (N=56) (52) found no difference between flexion and extension exercises for pain or patient global assessment at 1 month posttherapy.

[FIGURE 13 OMITTED]

At 6 to 12 months follow-up (not shown in the table), the relative reduction in pain was 60% (47) and the relative improvements in function were 0% in one trial (50) and 30% in another trial. (45) Two RCTs were pooled and showed no difference in sick days over 12 months (WMD=0.5 days, 95% CI = -1.5 to 2.5 days). (47,51)

Strength of Published Evidence in Comparison With Other Guidelines: The Philadelphia Panel found good scientific evidence (level I) of clinically important benefit on pain and function with stretching or strengthening exercises. In contrast, the QTF (20) found no scientific evidence for general exercises. The QTF (20) reviewed only one of the trials that was included in our meta-analysis.

Clinical Recommendations Compared With Other Guidelines: The Philadelphia Panel recommends that there is good evidence to include stretching, strengthening, and mobility exercises (grade A for pain and function, grade C for return to work) as interventions for chronic LBP. The BMJ (22) is in agreement with this EBCPG concerning strengthening exercises. The QTF (20) also recommended the prescription of general exercises as an option to increase strength, ROM, and endurance. The BMJ (22) reported that exercise could have adverse effects due to increased stress on the spine.

Practitioner Agreement

* Response rate for this EBCPG: 48%

* Percentage of practitioners giving comments for this EBCPG: 38%

* Agree with recommendation: 88%

* Think a majority of my colleagues would agree: 91%

* Will (or already) follow this recommendation: 81%

Practitioner Comments

1. Evidence for functional status is not convincing.

2. Be careful about lumping different types of exercise (eg, McKenzie and strengthening).

3. McKenzie exercises are insufficient for chronic LBP, useful only for acute LBP.

Article by O'Sullivan et al (53) on abdominal muscle re-education for spondylolisthesis should be included.

5. Neuromotor retraining should be included in this EBCPG.

Panel's Response: The evidence for functional status is based on 3 RCTs, 2 of which demonstrated greater than 15% improvement in function relative to the control group. Different exercises were not lumped; each article is presented separately in Tables 9 and 10. The McKenzie approach was evaluated for chronic LBP by one trial, which showed a 20% relative improvement in pain compared with the control, thus meeting the Philadelphia Panel criteria for clinically important improvement.44 The study by O'Sullivan et al (53) was excluded because neuromotor retraining was compared with a combined approach using exercises, heat, massage, and ultrasound, but not the control. The panel was not able to make any recommendations about neuromotor retraining, as there are no controlled studies evaluating the effectiveness of this intervention.

Mechanical Traction for Chronic LBP (> 12 Weeks), Level I (RCT), Grade C for Pain, Function, Patient Global Assessment, and Return to Work (No Benefit Demonstrated)

Summary of Trials: Four RCTs (N=176) of mechanical traction (2 intermittent and 2 static) versus placebo or untreated were included. (54-57) One RCT was excluded because it was impossible to separate the data for each treatment group. (58) One RCT was excluded because the traction force was only 10% of body weight and considered a placebo therapy. (47)

Efficacy: None demonstrated. There was no difference in pain, function, or patient global assessment. The point estimate for pain at 3 months favored the control group in the pooled analysis (WMD = -6.3, 95% CI=-15.8 to -3.1) (Fig. 14). However, work absence was shorter in the traction group after 6 months (35 days with traction versus 45 days without traction, but this was not statistically significant).

[FIGURE 14 OMITTED]

Strength of Published Evidence in Comparison With Other Guidelines: We found good evidence (level I) of no important benefit on pain, function, or patient-rated improvement of mechanical traction. In contrast, the QTF (20) found no scientific evidence.

Clinical Recommendations Compared With Other Guidelines: The Philadelphia Panel recommends that there is poor evidence to include or exclude mechanical traction alone (grade C for pain, function, patient global assessment, and return to work) as an intervention for chronic LBP. This EBCPG is in accordance with BMJ (22) clinical recommendations compared with other EBCPGs, but not the QTF, (20) which recommended mechanical traction as an option to increase ROM. According to the BMJ, (22) potential harms, not validated in trials, include (1) debilitation, (2) loss of muscle tone, (3) bone demineralization, and (4) thrombophlebitis.

Therapeutic Ultrasound for Chronic LBP (> 12 Weeks), Level II (CCT), Grade C for Pain (No Benefit Demonstrated)

Summary of Trials: One RCT (N=36) of continuous therapeutic ultrasound versus a placebo (59) was included.

Efficacy: None demonstrated. There was no difference in pain improvement between continuous therapeutic ultrasound and sham therapeutic ultrasound after 1 month of therapy (Fig. 15). (59) No data were reported for functional status, ROM, strength, quality of life, or return to work, and no data were available beyond 1 month.

[FIGURE 15 OMITTED]

Strength of Published Evidence in Comparison With Other Guidelines: We found fair scientific evidence (level II) that showed no clinically important benefit on pain with therapeutic ultrasound. The QTF (20) found no scientific evidence.

Clinical Recommendations Compared With Other Guidelines: The Philadelphia Panel recommends that there is poor evidence to include or exclude therapeutic ultrasound alone (grade C for pain) as an intervention for chronic LBP. This EBCPG is in concordance with BMJ (22) guidelines, despite a general statement on physical interventions, including therapeutic ultrasound. In contrast, the QTF (20) recommended the prescription of therapeutic ultrasound grouped with thermotherapy as an option to diminish muscle spasm and relieve symptomatic pain. There is insufficient information regarding adverse effects. (22)

TENS for Chronic LBP (> 12 Weeks), Level I (RCT), Grade C for Pain and Function (No Benefit Demonstrated)

Summary of Trials: Four CCTs (N=235) of TENS versus a placebo were included. (50,60-62) One observational study (N=78) was included, although some patients did not have LBP (but had other pain syndromes such as cervicalgia or phantom limb pain). (63) This study also allowed patients to self-select TENS based on its perceived effectiveness during 2 weeks of in-hospital therapy. One CCT was excluded because, of the 16 patients assigned to the treatment group, only 6 had LBP. (64) One RCT was excluded because the patient population was people with chronic myalgia and the etiology was not described. (65) Two RCTs were excluded due to lack of an appropriate control group (both used a form of massage as the comparison intervention). (66,67) Two crossover

RCTs were excluded because both the treatment and placebo groups received acupuncture needles. Acupuncture is thought to have an effect of its own and was excluded from the scope of this review. (68,69)

The method of application was acupuncture-like in one RCT. (50) Two trials used high-frequency (> 10 Hz) TENS, (60,61) 2 trials used low-frequency (4 Hz) TENS, (62) 1 trial alternated between both low- and high-frequency TENS, (50) and the other trial did not report the characteristics in sufficient detail. (63)

Efficacy: None demonstrated (Fig. 16). There was no difference in the pooled estimate of patient-rated pain at 1 month posttherapy (SMD=-0.2, 95% CI=-0.4 to 0.1). This SMD is equivalent to a difference between treatment and control groups of 4 mm on a 100-mm VAS for pain. In addition, there were no differences between placebo and TENS for functional status, ROM, or strength at 1 month posttherapy. At 3 to 6 months posttherapy, there was no difference in self-rated pain or activity level in any study. The pooled results were not affected by the quality of the trial, the frequency of TENS, or whether acupuncture or traditional TENS was applied. No side effects were reported for TENS.

[FIGURE 16 OMITTED]

Strength of Published Evidence in Comparison With Other Guidelines: The Philadelphia Panel found good evidence (level I) of no clinically important benefit on pain with TENS. This finding disagrees with the QTF, (20) which found weak scientific evidence based on a CCT. (67) This trial was excluded from our analysis due to lack of placebo (the comparison intervention was massage).

Clinical Recommendations Compared With Other Guidelines: The Philadelphia Panel recommends that there is poor evidence to include or exclude TENS alone (grade C for pain and function) as an intervention for chronic LBP. This EBCPG is in concordance with the BMJ (22) recommendations. In contrast, the QTF (20) recommended TENS as a rehabilitation modality for symptomatic pain relief, but this recommendation may include other forms of electroanalgesia. Insufficient information regarding adverse effects was reported by the BMJ. (22)

EMG Biofeedback for Chronic LBP (> 12 Weeks), Level I (RCT), Grade C for Pain and Function (No Benefit Demonstrated)

Summary of Trials: Five RCTs (N=162) of EMG biofeedback versus a control for chronic LBP were included. (72-76)

Efficacy: None demonstrated. Meta-analysis showed no effect on pain relief, functional status, or ROM after 1 month of therapy (Fig. 17). There were no data for quality of life or return to work. There were no data beyond 1 month.

[FIGURE 17 OMITTED]

Strength of Published Evidence in Comparison With Other Guidelines: The Philadelphia Panel found good scientific evidence (level I), which showed no clinically important benefit on pain or function with EMG biofeedback, but no scientific evidence. When no evidence was found, we rated it "insufficient data" regarding pastural exercises. The QTF (20) found no scientific evidence.

Clinical Recommendations Compared With Other Guidelines: The Philadelphia Panel recommends that there is poor evidence to include or exclude EMG biofeedback alone (grade C for pain and function) as intervention for chronic LBP. The BMJ (22) made no recommendation due to conflicting evidence related to EMG biofeedback. The QTF (20) recommended EMG biofeedback as an option to reduce muscle spasm. Pastural exercises were not studied by the QTF. (20) There is insufficient information regarding adverse effects for EMG biofeedback. (22)

Interventions for Chronic LBP With Insufficient Data

No eligible studies were found on which to base recommendations for thermotherapy, massage, or electrical stimulation (Tab. 5). This lack of evidence was also reported by the BMJ (22) and QTF (20) guidelines. However, both the QTF (20) and BMJ (22) recommend massage as an intervention for chronic LBP. Massage may have beneficial effects, as shown in an RCT published in abstract format. (75)

Combinations of rehabilitation interventions were classified by the Philadelphia Panel as having insufficient data to make a recommendation due to different combinations, unvalidated outcomes, and poor description of the actual interventions. This is in disagreement with the BMJ (22) and the QTF, (20) which both make general statements about the use of physical interventions in combination at the discretion of the rehabilitation specialist.

Deep abdominal stabilization exercises for patients with chronic spondylolisthesis improved pain and function relative to general exercises, heat, massage, and therapeutic ultrasound in one RCT (N=42), but no placebo comparison group was available. (53)

POSTSURGERY BACK PAIN

Therapeutic Exercises Post-Back Surgery, Level I (RCT), Grade A for Pain and Function (Clinically Important Benefit)

Summary of Trials: One RCT (N=200) with 3 groups was included that compared strengthening exercises versus McKenzie exercise versus no therapy. (79) One RCT of vigorous lumbar stabilizing exercises compared with mild exercises was excluded due to lack of a control group. (77)

Efficacy: Clinically important benefit was shown on pain and function with both types of exercise versus no therapy. Both the resisted exercises and the McKenzie program improved functional status by 51% relative to the control group (Tab. 11). The exercise groups improved more on ROM (flexion increased by 45% and extension increased by 109%) and strength (by 97%) at 2 months. Both exercise programs also extended the time to re-enter treatment for LBP by 51 weeks (95% CI=50-52) and 89 weeks (95% CI=69-110), respectively. (76)

Strength of Published Evidence in Comparison With Other Guidelines: The Philadelphia Panel found good scientific evidence (level I) of clinically important benefit on pain and function with back extension and strengthening exercises. In contrast, the QTF (20) found no scientific evidence for general exercises postsurgery.

Clinical Recommendations Compared With Other Guidelines: The Philadelphia Panel recommends that there is good evidence to include strengthening and extension exercises (grade A for pain and function) as an intervention for postsurgery LBP. This is in agreement with the BMJ, (22) which recommends strengthening exercises, and the QTF, (20) which recommends therapeutic exercises. The BMJ (22) guidelines reported that increased stress on the spine is a potential risk of therapeutic exercises.

Practitioner Agreement

* Response rate for this EBCPG: 46%

* Percentage of practitioners giving comments for this EBCPG: 24%

* Agree with recommendation: 90%

* Think a majority of my colleagues would agree: 83%

* Will (or already) follow this recommendation: 91%

Practitioner Comments

1. High-technology equipment (isotonic and isokinetic) is not practical in a clinical situation.

Panel's Response. The EBCPG recommends that either high-technology exercise or low-technology (traditional strengthening and McKenzie exercises) be used for postsurgery LBP.

DISCUSSION

Evidence-based practice is rapidly growing in the rehabilitation Domain, (78) especially for LBP. (6) This systematic review demonstrates that there are a number of rehabilitation interventions for LBP that have been shown in one or more controlled trials to provide a clinically important benefit. Such evidence is still needed for the other interventions.

However, as with all such reviews, there are a number of limitations. Methodologic issues such as the potential for publication bias, variations in the methodologic quality of the included trials, and lack of standardized outcomes are discussed in the Philadelphia Panel article on methodology in this issue ("Evidence-Based Clinical Practice Guidelines on Selected Rehabilitation Interventions: Overview and Methodology").

The effectiveness of conservative management of people with LBP is a complex issue. (6,79) Physical rehabilitation is defined as a combination of physical agents. Rehabilitation specialists often use concomitant interventions in their daily practice. (80) Each intervention is usually used as an adjunct. Certain interventions such as cryotherapy, hot pack application, and massage are used for pain relief or as a treatment preparation before the main intervention. The use of a single and specific intervention does not reflect the complexity of the global approach adopted by rehabilitation specialists in real-life clinical situations.

The effectiveness of physical rehabilitation interventions for LBP are thought to be influenced by a number of risk factors, (4,81-84) including biological, (85) psychosocial, (86-80) and occupational (90-94) health indicators. A multidimensional clinical evaluation is recommended in LBP management. (95,96) It was not possible to examine these risk factors in this review.

The Philadelphia Panel EBCPGs for the management of LBP are largely in agreement with previous and relatively recent EBCPGs (21,22) for LBP shown in Appendix 1. The Philadelphia Panel EBCPGs for LBP were developed based on a systematic grading of the evidence determined by an expert panel, and the evidence was derived from systematic reviews and meta-analyses using the Cochrane Collaboration methodology. The finalized guidelines were circulated for feedback from practitioners to verify their applicability and ease of use for practicing clinicians. This additional procedure provides credibility for rehabilitation specialists who intend to use these EBCPGs for LBP management in their daily practice.

Exercises

Our recommendations are in agreement with those of the AHCPR guidelines that continuation of normal activities (such as walking) is more effective than bed rest for the management of acute LBP. (15)

Extension, Strengthening, or Flexion Exercises: Our systematic review (30-32,39,44-47,51,52,76,97-101) also showed that extension, flexion, or strengthening exercises are effective for subacute and chronic LBP and for postsurgery LBP. The results for acute LBP are in full agreement with guidelines and other reviews (6,102) concerning moderate effectiveness of stretching or strengthening exercises, but highly effective "advice to stay active." (103) Certain authors recommend return to functional and work activities as soon as possible after lumbar injury to avoid the negative effects of immobilization and bed rest prescription. (104,105) Task-oriented activities are recognized in rehabilitation. Patients with LBP benefit from these activities as they improve ADL. For chronic LBP, our results are concordant with the summary by van Tulder et al (6) on the effects of exercise therapy (flexion, extension, strengthening). Exercise therapy for subacute and for postsurgery LBP was not considered by van Tulder et al. (6) For subacute and chronic LBP conditions, our conclusions are in full agreement with the results of Faas. (106) In future studies, it will be important to look at clarifying types of exercises used, adequate exercise intensity, and progression according to patient-specific classification of physical dysfunction, needs, treatment goals, and outcomes. (95,107-110)

Mechanical Traction

Eleven RCTs of static, intermittent, or vertical traction have been conducted in acute, subacute, and chronic LBP. (24-27,33-35,54,56,58,111) None of these RCTs showed evidence of clinically 'important benefit (56) on any of the outcomes identified as patient-important outcomes by the Philadelphia Panel; thus, neither static nor intermittent mechanical traction was shown to be of clinically important benefit. This lack of important benefit was consistent for acute, subacute, and chronic LBP as well as for static and intermittent traction. These results agree with previous systematic reviews for acute and chronic LBP management, (6) even though those reviews did not clearly distinguish between manual and mechanical traction.

It would have been of great interest to pool the results of different subgroups in order to evaluate whether the presence or absence of neurological signs influenced the results. Unfortunately, subgroup analyses across the different trials according to specific clinical characteristics were not possible due to noncomparable outcome measures. Our systematic review included a mix of patients with and without neurological signs in 4 out of 11 trials. (23,34,54,58) Therefore, our results appear to be robust across mixed conditions. However, as none of these 4 trials included patients with disk involvement, no conclusions can be drawn about effects in patients with disk involvement.

Some have claimed that the clinical indication for static or sustained traction is the presence of a nuclear disk protrusion. (112,113) Of the 11 trials, 2 included populations in which all patients had disk involvement, (25,26) and 2 included a mix of patients with and without nuclear disk protrusions. (50,57) The results of these 3 trials were consistent with the others, showing no evidence of clinical benefit. This point shows the importance of identifying homogenous subgroups of patients with LBP based on precise differential physical dysfunction diagnostic classes, such as nerve root adhesion, hypomobility dysfunction, and sacroiliac hypermobility. (114) However, current literature does not support the suggestion that lumbar traction has a beneficial effect on LBP (111,115) by repairing disk herniations.

Therapeutic Ultrasound

Therapeutic ultrasound has not been shown to provide clinically important benefit for acute LBP (28) or chronic LBP. (59) The Philadelphia Panel recommendation (level II, grade C) agrees with the AHCPR (21) and BMJ (22) guidelines that evidence for the effectiveness of therapeutic ultrasound is lacking. Comparison with the results of van Tulder and colleagues' (6) systematic review was not possible because they found no RCTs that met their criteria. However, the QTF (20) recommended therapeutic ultrasound for muscle spasm and pain relief. This QTF recommendation was based on common practice rather than any evidence from clinical trials. Furthermore, this recommendation grouped therapeutic ultrasound with thermotherapy.

The only 2 trials available were both of low quality (0 out of 5 on the Jadad scale (11,12)). Furthermore, the type of therapeutic ultrasound was continuous in the study by Roman (59) and not specified in the other trial. (28) A pulsed therapeutic ultrasound type may be more effective than continuous therapeutic ultrasound in acute conditions because of a nonthermal effect. (116) These results concur with a previous systematic review, (80) even though it was conducted for all musculoskeletal conditions.

TENS

Despite several RCTs of TENS, no consistent benefit was shown on clinically relevant outcomes (eg, pain, functional status, patient global assessment) for acute, subacute, or chronic LBP. (29,50,60-64) Subgroup analyses revealed no significant differences between acute and chronic conditions, low- and high-quality studies, or conventional and acupuncture-like application or duration of the TENS session. These results are in concordance with previous systematic reviews for acute and chronic LBP. (6,117) The Philadelphia Panel EBCPGs (level I, grade C) are in agreement with AHCPR (21) and BMJ (22) guidelines, which do not recommend TENS for LBP, but they are in conflict with the QTF (20) guidelines, which recommend TENS for pain relief. However, the QTF (20) guidelines do not differentiate between electroanalgesia and TENS. Specific therapeutic application of TENS is of key importance. Vibratory stimulation has been recommended as part of the TENS application, especially for chronic pain relief. (65,118,119) None of the trials included in our review considered vibratory stimulation. There is a need for strict and rigorous RCTs of TENS using combined vibratory stimulation.

Therapeutic Massage

There were insufficient data for the Philadelphia Panel to make a recommendation for therapeutic massage as an intervention for acute, subacute, or chronic LBP. The current results are in full agreement with 2 recent systematic reviews. (6,120) However, a recent, large unpublished trial suggests that massage may have a clinically important benefit. (75)

The Philadelphia Panel recommendation agrees with the AHCPR, (21) which concluded that insufficient evidence regarding massage was available. However, the Philadelphia Panel disagrees with both the BMJ (22) and QTF (20) recommendations that massage should be considered as a therapeutic option in LBP, particularly for the relief of muscle spasm. The QTF (20) and BMJ (22) recommendations were made based on common practice rather than any evidence from controlled clinical trials.

Massage is a global intervention involving a number of confounding variables related to the therapeutic application. For example, the effectiveness of massage is influenced by the types of maneuvers used, the massage approach adopted, years of experience of the therapist, the number and the size of the muscles involved, the patient position used, the pressure exerted, the rhythm and progression, and the frequency and duration of the treatment sessions. (120)

Thermotherapy

There was insufficient evidence to make a recommendation regarding thermotherapy as an intervention for acute or chronic LBP. These results are in agreement with a recent systematic review (6) for chronic LBP and with the evidence ratings of the AHCPR (21) and QTF (20) guidelines. However, the QTF (20) recommended thermotherapy as an intervention for acute LBP.

Only comparative trials (56,66,121) were identified for chronic LBP. In these trials, the separate effects of ice or heat could not be determined because they were used in conjunction with other interventions or compared with other interventions of unknown therapeutic benefit.

Physiological studies have shown significant effects of cryotherapy on circulatory and temperature responses and on muscle spasm and inflammation, (122),123) but the mechanism of action has not yet been fully elucidated. (123) It is unknown whether these physiological effects translate to important effects on clinical outcomes (such as pain and functional status). Back muscles may be too thick to benefit from the penetrating effects of superficial, local ice application for pain relief. (123)

Electrical Stimulation

The Philadelphia Panel was unable to make a recommendation regarding electrical stimulation due to insufficient evidence. There are some head-to-head studies, (61, 24) but in the absence of placebo controls, efficacy cannot be established. This is in agreement with AHCPR21 guidelines. The BMJ (22) and QTF (20) did not evaluate this modality.

Electrical stimulation is thought to increase functional activity if the peripheral nervous system is intact. (125) Only Pope et al (124) excluded patients with LBP who had neurological deficits. It has been recommended for physical rehabilitation in the upper and lower extremities in patients with LBP. (125) To our knowledge, no other systematic reviews have studied this specific therapeutic intervention.

EMG Biofeedback

No consistent clinically important benefit was found for EMG biofeedback for either acute LBP (126) or chronic LBP. (70,72-74) Two trials used EMG biofeedback for back muscle relaxation. (72,74) The other trials (70,73,126) used EMG biofeedback to improve muscle activation control. Only 2 trials (70,126) excluded patients with root and peripheral nerve entrapment. Electromyographic biofeedback (126) may be important in the relief of muscle spasms in people with acute LBP. (127) Our results are in concordance with other guidelines and the review by van Tulder et al. (6)

Combined Rehabilitation Interventions

For both acute and chronic LBP, the Philadelphia Panel concluded that insufficient evidence was available regarding rehabilitation interventions when several are combined. This differs from the QTF(20) and BMJ(22) guidelines, which both recommend that rehabilitation specialists use interventions in combination at their own discretion to achieve treatment goals. The extent to which multiple interventions are redundant needs to be assessed in the same fashion as individual interventions.

The studies of combinations that were found used heterogeneous modalities, many of which were not described in sufficient detail to allow replication.(41,42,56,128-130) Furthermore, comparisons among studies are difficult because the investigators did not select the same combination of rehabilitation interventions. Methodological quality was low in these studies.

Overall

The main difficulty in determining the effectiveness of rehabilitation interventions is the lack of well-designed prospective RCTs. Future research in physical therapy should adopt rigorous methods such as the use of an appropriate placebo (and double-blind procedure), adequate randomization, homogeneous sample of patients based on rigorous selection and diagnosis criteria, and adequate sample size to detect clinically important differences with confidence.

CONCLUSION

There is evidence to support and recommend the use of continued normal activities for acute nonspecific LBP and therapeutic exercises for chronic, subacute, and postsurgery LBP. These EBCPGs were developed with a transdisciplinary team approach, using a structured methodology for guideline development that includes practitioner feedback. There is a lack of evidence at present regarding whether to include or exclude the use of thermotherapy, therapeuiic massage, EMG biofeedback, mechanical traction, therapeutic ultrasound, TENS, electrical stimulation, and combined rehabilitation interventions in the daily practice of physical rehabilitation.

Appendix 1.

Strength of Published Evidence and Clinical Recommendations of
Previous Evidence-Based Clinical Practice Guidelines (EBCPGs) for
Low Back Pain (a)

Rehabilitation
Intervention                                  Philadelphia Panel
                                              (2001)

Previous EBCPGs for Acute Low Back Pain (LBP) (<4 wk)

Therapeutic        Strength of published      Good scientific evidence
  exercises          evidence in comparison     (level I) for light
                     with other guidelines      functional activities
                                                and therapeutic
                                                exercises

                   Clinical recommendations   Poor evidence to include
                     compared with other        or exclude (grade C for
                     guidelines                 pain, function, and
                                                return to work)
                                                flexion, extension,
                                                and strengthening
                                                exercises

                                              Good evidence (grade A
                                                for return to work,
                                                grade C for pain and
                                                function) to include
                                                light functional
                                                activities, such as
                                                walking, within the
                                                first week of acute
                                                LBP

Mechanical         Strength of published      Good scientific evidence
  traction           evidence in comparison     (level 1) for
                     with other guidelines      mechanical traction

                   Clinical recommendations   Poor evidence to include
                     compared with other        or exclude (grade C
                     guidelines                 for pain and patient
                                                global assessment)
                                                mechanical traction
                                                alone as an
                                                intervention for
                                                acute LBP

Therapeutic        Strength of published      Fair scientific evidence
  ultrasound         evidence in comparison     (level II) for
                     with other guidelines      therapeutic ultrasound

                   Clinical recommendations   Poor evidence to include
                     compared with other        or exclude (grade C for
                     guidelines                 pain) therapeutic
                                                ultrasound alone as an
                                                intervention for acute
                                                LBP

TENS               Strength of published      Good scientific evidence
                     evidence in comparison     (level I) for TENS
                     with other guidelines

                   Clinical recommendations   Poor evidence to include
                     compared with other        or exclude (grade C
                     guidelines                 for pain and function)
                                                TENS alone as an
                                                intervention for acute
                                                LBP

EMG biofeedback    Strength of published      Insufficient scientific
                     evidence in comparison     evidence (level ID)
                     with other guidelines      for EMG biofeedback

                   Clinical recommendations   Insufficient evidence to
                     compared with other        include or exclude
                     guidelines                 (grade ID) EMG
                                                biofeedback alone
                                                as an intervention for
                                                acute LBP

Therapeutic        Strength of published      Insufficient scientific
  massage            evidence in comparison     evidence (level ID)
                     with other guidelines      for therapeutic
                                                massage

                   Clinical recommendations   Insufficient evidence to
                     compared with other        include or exclude
                     guidelines                 (grade ID) therapeutic
                                                 massage alone as an
                                                intervention for acute
                                                LBP

Thermotherapy      Strength of published      N/A
                     evidence in comparison
                     with other guidelines

                   Clinical recommendations   No data found
                     compared with other
                     guidelines

Electrical         Strength of published      N/A
  stimulation        evidence in comparison
                     with other guidelines

                   Clinical                   No data found
                     recommendations
                     compared with other
                     guidelines

Combined           Strength of published      N/A
  rehabilitation     evidence in comparison
  interventions      with other guidelines

                   Clinical recommendations   No data found
                     compared with other
                     guidelines

Previous EBCPGs for Subacute LBP (4-12 wk)

Therapeutic        Strength of published      Good scientific evidence
  exercises          evidence in comparison     (level I) for
                     with other guidelines      therapeutic exercises

                   Clinical recommendations   Good evidence (grade A
                     compared with other        for pain, function,
                     guidelines                 and patient global
                                                assessment) to include
                                                flexion, extension,
                                                and strengthening
                                                exercises

Mechanical         Strength of published      Good scientific evidence
  traction           evidence in comparison     (level I) for
                     with other guidelines      mechanical traction

                   Clinical recommendations   Poor evidence to include
                     compared with other        or exclude (grade C for
                     guidelines                 patient global
                                                assessment and return
                                                to work) mechanical
                                                traction alone as an
                                                intervention for
                                                acute LBP

Previous EBCPGs for Chronic LBP (> 12 wk)

Therapeutic        Strength of published      Good scientific evidence
  exercises          evidence in comparison     (level I) for
                     with other guidelines      therapeutic exercises

                   Clinical recommendations   Good evidence (grade A
                     compared with other        for pain and function,
                     guidelines                 grade C for return to
                                                work) to include
                                                flexion, extension,
                                                and strengthening
                                                exercises

Mechanical         Strength of published      Good scientific evidence
  traction           evidence in comparison     (level I) for
                     with other guidelines      mechanical traction

                   Clinical recommendations   Poor evidence to include
                     compared with other        or exclude (grade C
                     guidelines                 for pain, function,
                                                patient global
                                                assessment, and return
                                                to work) mechanical
                                                traction alone as an
                                                intervention for
                                                chronic LBP

Therapeutic        Strength of published      Fair scientific evidence
  ultrasound         evidence in comparison     (level II) for
                     with other guidelines      therapeutic ultrasound

                   Clinical recommendations   Poor evidence to include
                     compared with other        or exclude (grade C
                     guidelines                 pain) therapeutic
                                                ultrasound alone as an
                                                intervention for
                                                chronic LBP

TENS               Strength of published      Good scientific evidence
                     evidence in comparison     (level I) for TENS
                     with other guidelines

                   Clinical recommendations   Poor evidence to include
                     compared with other        or exclude (grade C for
                     guidelines                 pain and function) TENS
                                                alone as an
                                                intervention for
                                                chronic LBP

EMG biofeedback    Strength of published      Good scientific evidence
                     evidence in comparison     (level I) for EMG
                     with other guidelines      biofeedback

                   Clinical recommendations   Poor evidence to include
                     compared with other        or exclude (grade C
                     guidelines                 for pain and function)
                                                EMG
                                              Biofeedback alone as an
                                                intervention for
                                                chronic LBP

Therapeutic        Strength of published      Insufficient scientific
  massage            evidence in comparison     evidence (level ID)
                     with other guidelines      for therapeutic
                                                massage

                   Clinical recommendations   Insufficient evidence to
                     compared with other        include or exclude
                     guidelines                 (grade ID) therapeutic
                                                massage alone as an
                                                intervention for
                                                chronic LBP

Thermotherapy      Strength of published      Insufficient scientific
                     evidence in comparison     evidence (level ID)
                     with other guidelines      for thermotherapy

                   Clinical recommendations   Insufficient evidence to
                     compared with other        include or exclude
                     guidelines                 (grade ID)
                                                thermotherapy alone as
                                                an intervention for
                                                chronic LBP

Electrical         Strength of published      Insufficient scientific
  stimulation        evidence in comparison     evidence (level ID) for
                     with other guidelines      electrical stimulation

                   Clinical recommendations   Insufficient evidence to
                     compared with other        include or exclude
                     guidelines                 (grade ID) electrical
                                                stimulation alone as
                                                an intervention for
                                                chronic LBP

Combined           Strength of published      Insufficient scientific
  rehabilitation     evidence in comparison     evidence (level ID)
  interventions      with other guidelines      for combined
                                                rehabilitation
                                                interventions

                   Clinical recommendations   Insufficient evidence to
                     compared with other        include or exclude
                     guidelines                 (grade ID) as combined
                                                rehabilitation as
                                                interventions for
                                                chronic LBP

Previous EBCPGs for Postsurgery LBP (4-12 wk)

Therapeutic        Strength of published      Good scientific evidence
  exercises          evidence in comparison     (level I) for
                     with other guidelines      therapeutic exercises

                   Clinical recommendations   Good evidence (grade A for
                     compared with other        pain and function) to
                     guidelines                 include extension and
                                                strengthening exercises

Rehabilitation                                  Quebec Task Force (20)
Intervention                                    (1987)

Previous EBCPGs for Acute Low Back Pain (LBP) (<4 wk)

Therapeutic        Strength of published      Common practice, but no
  exercises          evidence in comparison     scientific evidence
                     with other guidelines

                   Clinical recommendations   Listed as option to
                     compared with other        increase strength,
                     guidelines                 ROM, and endurance

Mechanical         Strength of published      Common practice, but no
  traction           evidence in comparison     scientific evidence
                     with other guidelines

                   Clinical recommendations   Listed as option to
                     compared with other        increase ROM
                     guidelines

Therapeutic        Strength of published      Common practice, but no
  ultrasound         evidence in comparison     scientific evidence
                     with other guidelines

                   Clinical recommendations   Therapeutic ultrasound
                     compared with other        is grouped with
                     guidelines                 thermotherapy and
                                                listed as an option
                                                to diminish muscle
                                                spasm and relieve
                                                symptomatic pain

TENS               Strength of published      Not in common practice,
                     evidence in comparison     but no scientific
                     with other guidelines      evidence

                   Clinical recommendations   Electroanalgesia is
                     compared with other        listed as an option
                     guidelines                 for symptomatic pain
                                                relief

EMG biofeedback    Strength of published      Common practice, but no
                     evidence in comparison     scientific evidence
                     with other guidelines

                   Clinical recommendations   EMG biofeedback is
                     compared with other        listed as an option
                     guidelines                 to diminish muscle
                                                spasm

Therapeutic        Strength of published      Common practice, but no
  massage            evidence in comparison     scientific evidence
                     with other guidelines

                   Clinical recommendations   Therapeutic massage is
                     compared with other        listed as an option
                     guidelines                 to diminish muscle
                                                spasm

Thermotherapy      Strength of published      Common practice, but no
                     evidence in comparison     scientific evidence
                     with other guidelines

                   Clinical recommendations   Thermotherapy is listed
                     compared with other        as an option to
                     guidelines                 diminish muscle spasm
                                                and inflammation and
                                                to relieve symptomatic
                                                pain

Electrical         Strength of published      N/C
  stimulation        evidence in comparison
                     with other guidelines

                   Clinical                   N/C
                     recommendations
                     compared with other
                     guidelines

Combined           Strength of published      N/C
  rehabilitation     evidence in comparison
  interventions      with other guidelines

                   Clinical recommendations   Recommended that
                     compared with other        physical therapists
                     guidelines                 use physical modalities
                                                and interventions at
                                                their own discretion
                                                with the objectives of
                                                relieving spasm,
                                                reducing inflammation,
                                                reducing pain, and
                                                increasing strength,
                                                ROM, endurance, and
                                                physical and functional
                                                status

Previous EBCPGs for Subacute LBP (4-12 wk)

Therapeutic        Strength of published      Common practice, but no
  exercises          evidence in comparison     scientific evidence
                     with other guidelines

                   Clinical recommendations   Listed as option to
                     compared with other        increase strength,
                     guidelines                 ROM, and endurance

Mechanical         Strength of published      Common practice, but no
  traction           evidence in comparison     scientific evidence
                     with other guidelines

                   Clinical recommendations   Listed as option to
                     compared with other        increase ROM
                     guidelines

Previous EBCPGs for Chronic LBP (> 12 wk)

Therapeutic        Strength of published      Usefulness demonstrated
  exercises          evidence in comparison     by nonrandomized
                     with other guidelines      controlled trial

                   Clinical recommendations   Listed as option to
                     compared with other        increase strength,
                     guidelines                 ROM, and endurance

Mechanical         Strength of published      Common practice, but no
  traction           evidence in comparison     scientific evidence
                     with other guidelines

                   Clinical recommendations   Listed as option to
                     compared with other        increase ROM
                     guidelines

Therapeutic        Strength of published      Common practice, but no
  ultrasound         evidence in comparison     scientific evidence
                     with other guidelines

                   Clinical recommendations   Therapeutic ultrasound is
                     compared with other        grouped with
                     guidelines                 thermotherapy and
                                                listed as an option to
                                                diminish muscle spasm
                                                and relieve
                                                symptomatic pain

TENS               Strength of published      Usefulness demonstrated
                     evidence in comparison     by nonrandomized
                     with other guidelines      controlled trial

                   Clinical recommendations   Electroanalgesia is
                     compared with other        listed as an option
                     guidelines                 for symptomatic pain
                                                relief

EMG biofeedback    Strength of published      Common practice, but no
                     evidence in comparison     scientific evidence
                     with other guidelines

                   Clinical recommendations   EMG biofeedback is
                     compared with other        listed as an option to
                     guidelines                 diminish muscle spasm

Therapeutic        Strength of published      Common practice, but no
  massage            evidence in comparison     scientific evidence
                     with other guidelines

                   Clinical recommendations   Therapeutic massage is
                     compared with other        listed as an option to
                     guidelines                 diminish muscle spasm,
                                                but not for reduction
                                                of pain or not to
                                                increase function
                                                status

Thermotherapy      Strength of published      Common practice, but no
                     evidence in comparison     scientific evidence
                     with other guidelines

                   Clinical recommendations   Thermotherapy is listed
                     compared with other        as an option to
                     guidelines                 diminish muscle spasm
                                                and inflammation and
                                                to relieve symptomatic
                                                pain

Electrical         Strength of published      N/C
  stimulation        evidence in comparison
                     with other guidelines

                   Clinical recommendations   N/C
                     compared with other
                     guidelines

Combined           Strength of published      N/C
  rehabilitation     evidence in comparison
  interventions      with other guidelines

                   Clinical recommendations   Recommended that
                     compared with other        physical therapists
                     guidelines                 use physical
                                                modalities and
                                                interventions at their
                                                own discretion with
                                                the objctives of
                                                relieving spasm,
                                                reducing inflammation,
                                                reducing pain, and
                                                increasing strength,
                                                ROM, endurance, and
                                                physical and
                                                functional status

Previous EBCPGs for Postsurgery LBP (4-12 wk)

Therapeutic        Strength of published      N/R for postsurgery LBP
  exercises          evidence in comparison
                     with other guidelines

                   Clinical recommendations   N/R for postsurgery LBP
                     compared with other
                     guidelines

Rehabilitation
Intervention                                  AHCPR (21) (1994)

Previous EBCPGs for Acute Low Back Pain (LBP) (<4 wk)

Therapeutic        Strength of published      Limited research-based
  exercises          evidence in comparison     evidence (at least one
                     with other guidelines      adequate scientific
                                                study)

                   Clinical recommendations   Evidence does not
                     compared with other        support stretching
                     guidelines                 exercises alone

                                              Low-stress aerobic
                                                exercises are
                                                recommended within
                                                the first week of
                                                acute LBP

Mechanical         Strength of published      Moderate research-based
  traction           evidence in comparison     evidence (one
                     with other guidelines      relevant, high-quality
                                                scientific study or
                                                multiple adequate
                                                scientific studies)

                   Clinical recommendations   Spinal traction is not
                     compared with other        recommended in the
                     guidelines                 management of patients
                                                with acute LBP

Therapeutic        Strength of published      Limited research-based
  ultrasound         evidence in comparison     evidence (at least one
                     with other guidelines      adequate scientific
                                                study)

                   Clinical recommendations   Use of physical agents
                     compared with other        is of poorly
                     guidelines                 substantiated
                                                benefit to justify
                                                their cost in acute
                                                LBP

TENS               Strength of published      Limited research-based
                     evidence in comparison     evidence (at least one
                     with other guidelines      adequate scientific
                                                study)

                   Clinical recommendations   TENS is not recommended
                     compared with other        in the management of
                     guidelines                 patients with acute
                                                LBP

EMG biofeedback    Strength of published      N/C
                     evidence in comparison
                     with other guidelines

                   Clinical recommendations   N/C
                     compared with other
                     guidelines

Therapeutic        Strength of published      Limited research-based
  massage            evidence in comparison     evidence (at least one
                     with other guidelines      adequate scientific
                                                study)

                   Clinical recommendations   Use of physical agents
                     compared with other        is of poorly
                     guidelines                 substantiated
                                                benefit to justify
                                                their cost in acute
                                                LBP

Thermotherapy      Strength of published      Limited research-based
                     evidence in comparison     evidence (at least one
                     with other guidelines      adequate scientific
                                                study)

                   Clinical recommendations   Use of physical agents
                     compared with other        is of poorly
                     guidelines                 substantiated benefit
                                                to justify their cost
                                                in acute LBP

Electrical         Strength of published      N/C
  stimulation        evidence in comparison
                     with other guidelines

                   Clinical                   N/C
                     recommendations
                     compared with other
                     guidelines

Combined           Strength of published
  rehabilitation     evidence in comparison
  interventions      with other guidelines

                   Clinical recommendations   N/C
                     compared with other
                     guidelines

Previous EBCPGs for Subacute LBP (4-12 wk)

Therapeutic        Strength of published      Limited research-based
  exercises          evidence in comparison     evidence (at least one
                     with other guidelines      adequate scientific
                                                study)

                   Clinical recommendations   Evidence does not
                     compared with other        support stretching
                     guidelines                 exercises alone

Mechanical         Strength of published      Moderate research-based
  traction           evidence in comparison     evidence (one
                     with other guidelines      relevant, high-quality
                                                scientific study or
                                                multiple adequate
                                                scientific studies)

                   Clinical recommendations   Spinal traction is not
                     compared with other        recommended in the
                     guidelines                 management of patients
                                                with acute LBP

Previous EBCPGs for Chronic LBP (> 12 wk)

Therapeutic        Strength of published      N/C
  exercises          evidence in comparison
                     with other guidelines

                   Clinical recommendations   N/C
                     compared with other
                     guidelines

Mechanical         Strength of published      N/C
  traction           evidence in comparison
                     with other guidelines

                   Clinical recommendations   N/C
                     compared with other
                     guidelines

Therapeutic        Strength of published      N/C
  ultrasound         evidence in comparison
                     with other guidelines

                   Clinical recommendations   N/C
                     compared with other
                     guidelines

TENS               Strength of published      N/C
                     evidence in comparison
                     with other guidelines

                   Clinical recommendations   N/C
                     compared with other
                     guidelines

EMG biofeedback    Strength of published      N/C
                     evidence in comparison
                     with other guidelines

                   Clinical recommendations   N/C
                     compared with other
                     guidelines

Therapeutic        Strength of published      N/C
  massage            evidence in comparison
                     with other guidelines

                   Clinical recommendations   N/C
                     compared with other
                     guidelines

Thermotherapy      Strength of published      N/C
                     evidence in comparison
                     with other guidelines

                   Clinical recommendations   N/C
                     compared with other
                     guidelines

Electrical         Strength of published      N/C
  stimulation        evidence in comparison
                     with other guidelines

                   Clinical recommendations   N/C
                     compared with other
                     guidelines

Combined           Strength of published      N/C
  rehabilitation     evidence in comparison
  interventions      with other guidelines

                   Clinical recommendations   N/C
                     compared with other
                     guidelines

Previous EBCPGs for Postsurgery LBP (4-12 wk)

Therapeutic        Strength of published      N/R for postsurgery LBP
  exercises          evidence in comparison
                     with other guidelines

                   Clinical recommendations   N/R for postsurgery LBP
                     compared with other
                     guidelines

Rehabilitation
Intervention                                  BMJ (22) (2000)

Previous EBCPGs for Acute Low Back Pain (LBP) (<4 wk)

Therapeutic        Strength of published      N/R
  exercises          evidence in comparison
                     with other guidelines

                   Clinical recommendations   No evidence that
                     compared with other        flexion, extension,
                     guidelines                 aerobics, and
                                                strengthening are more
                                                effective than other
                                                conservative
                                                interventions for
                                                acute LBP

Mechanical         Strength of published      N/R
  traction           evidence in comparison
                     with other guidelines

                   Clinical recommendations   No evidence that
                     compared with other        traction is more
                     guidelines                 effective than other
                                                conservative
                                                interventions for
                                                acute LBP

Therapeutic        Strength of published      N/R
  ultrasound         evidence in comparison
                     with other guidelines

                   Clinical recommendations   Insufficient evidence of
                     compared with other        the effects of
                     guidelines                 physical interventions
                                                in acute LBP

TENS               Strength of published      N/R
                     evidence in comparison
                     with other guidelines

                   Clinical recommendations   Insufficient evidence of
                     compared with other        the effects of TENS in
                     guidelines                 acute LBP

EMG biofeedback    Strength of published      N/R
                     evidence in comparison
                     with other guidelines

                   Clinical recommendations   Insufficient evidence of
                     compared with other        the effects of EMG
                     guidelines                 biofeedback in acute
                                                LBP

Therapeutic        Strength of published      N/R
  massage            evidence in comparison
                     with other guidelines

                   Clinical recommendations   Insufficient evidence of
                     compared with other        the effects of
                     guidelines                 physical interventions
                                                in acute LBP

Thermotherapy      Strength of published        N/R
                     evidence in comparison
                     with other guidelines

                   Clinical recommendations   Insufficient evidence of
                     compared with other        the effects of
                     guidelines                 physical interventions
                                                in acute LBP

Electrical         Strength of published      N/C
  stimulation        evidence in comparison
                     with other guidelines

                   Clinical                   N/C
                     recommendations
                     compared with other
                     guidelines

Combined           Strength of published      N/R
  rehabilitation     evidence in comparison
  interventions      with other guidelines

                   Clinical recommendations   Insufficient evidence of
                     compared with other        the effects of
                     guidelines                 physical interventions
                                                in acute LBP

Previous EBCPGs for Subacute LBP (4-12 wk)

Therapeutic        Strength of published      N/R
  exercises          evidence in comparison
                     with other guidelines

                   Clinical recommendations   No evidence that
                     compared with other        flexion, extension,
                     guidelines                 aerobics, and
                                                strengthening are more
                                                effective than other
                                                conservative
                                                interventions for acute
                                                LBP

Mechanical         Strength of published      N/R
  traction           evidence in comparison
                     with other guidelines

                   Clinical recommendations   No evidence that
                     compared with other        traction is more
                     guidelines                 effective than other
                                                conservative
                                                interventions for
                                                acute LBP

Previous EBCPGs for Chronic LBP (> 12 wk)

Therapeutic        Strength of published      N/R
  exercises          evidence in comparison
                     with other guidelines

                   Clinical recommendations   Good evidence that
                     compared with other        flexion, extension,
                     guidelines                 aerobics, and
                                                strengthening are
                                                more effective than
                                                other conservative
                                                interventions for
                                                chronic LBP

Mechanical         Strength of published      N/R
  traction           evidence in comparison
                     with other guidelines

                   Clinical recommendations   No evidence that
                     compared with other        traction is more
                     guidelines                 effective than other
                                                conservative
                                                interventions for
                                                chronic LBP

Therapeutic        Strength of published      N/R
  ultrasound         evidence in comparison
                     with other guidelines

                   Clinical recommendations   Insufficient evidence on
                     compared with other        the effects of
                     guidelines                 physical interventions
                                                in chronic LBP

TENS               Strength of published      N/R
                     evidence in comparison
                     with other guidelines

                   Clinical recommendations   Insufficient evidence of
                     compared with other        the effects of TENS in
                     guidelines                 chronic LBP

EMG biofeedback    Strength of published      N/R
                     evidence in comparison
                     with other guidelines

                   Clinical recommendations   Conflicting evidence on
                     compared with other        the effects of EMG
                     guidelines                 biofeedback in chronic
                                                LBP

Therapeutic        Strength of published      N/R
  massage            evidence in comparison
                     with other guidelines

                   Clinical recommendations   Insufficient evidence of
                     compared with other      the effects of physical
                     guidelines               interventions in chronic
                                              LBP

Thermotherapy      Strength of published      N/R
                     evidence in comparison
                     with other guidelines

                   Clinical recommendations   Insufficient evidence of
                     compared with other        the effects of
                     guidelines                 physical interventions
                                                in chronic LBP

Electrical         Strength of published      N/C
  stimulation        evidence in comparison
                     with other guidelines

                   Clinical recommendations   N/C
                     compared with other
                     guidelines

Combined           Strength of published      N/R
  rehabilitation     evidence in comparison
  interventions      with other guidelines

                   Clinical recommendations   Insufficient evidence of
                     compared with other        the effects of
                     guidelines                 physical interventions
                                                in chronic LBP

Previous EBCPGs for Postsurgery LBP (4-12 wk)

Therapeutic        Strength of published      N/R for postsurgery LBP
  exercises          evidence in comparison
                     with other guidelines

                   Clinical recommendations   N/R for postsurgery LBP
                     compared with other
                     guidelines

(a) N/A=not applicable, N/C=not considered, N/R=not reported,
TENS=transcutaneous electrical nerve simulation,
EMG=electromyographic, ROM=range of motion, AHCPR=Agency for Health
Care Policy and Research, BMJ=British Medical Journal. Interventions
with no data are not shown.
Appendix 2.

Description of Included Trials (a)

                       Sample   Radiating/Positive
Author/Year            Size     SLR/Neurologic/Disk    Age (y) (SD)

Asfour et al, (70)       30     NR/NR/no/no            46.53 (17.62)
  1990

Beurskens and           151     Mixed/NR/NR/no         42 (11)
  colleagues, (54,55)
  1995, 1997

Bush et al, (71)         72     NR/NR/no/no            20-65
  1985

Cherkin et al, (31)     226     No/NR/no/NR            40.1 (11.2)
  1998

Coxhead et al, (58)     322     All/NR/NR (included    41.9 (12.2)
  1981                            paresthesia)

Davies et al, (32)       47     NR/NR/no/no            24
  1979

Dehlin et al, (48)       32                            29 (11)
  1978

Dehlin et al, (49)       45     NR/NR/NR/NR            31 (11)
  1981

Deyo et al, (50)        145     Mixed/NR/mixed/mixed   50.6
  1990

Evans et al, (13)       186     Mixed/NR/no/NR         40.1 (14.51)
  1987

Faas and                473     Mixed/NR/no/NR         38
  colleagues, (14,19)
  1993, 1995

Frost and                81     No/NR/NR/NR            38.5 (9.3)
  colleagues, (45)
  1995

Gemignani et             20     NR/NR NR/NR (all       NR
  al., (62) 1991                  ankylosing

                                  spondylitis)

Hansen et al, (47)      180     Mixed/no/no?/NR        41.9
  1993                            (included
                                  radiculation
                                  but excluded
                                  clinical
                                  signs of root
                                  compression)

Herman et al, (29)       58     NR/NR NR/NR            41.7 (11.4)
  1994

Hides et al, (126)       39     Mixed/NR/no/NR         31 (7.9)
  1996

Kellett et              125     NR/NR/NR/NR            42.13 (9.95)
  al, (51) 1991

Kuukkanen and            86     No/NR/NR/NR            39.9 (7.9)
  Malkia, (101)
  1996

Lidstrom and             62     All/mixed/mixed/no     39
  Zachrisson, (56)                (excluded disk
  1970                            prolapse)

Malmivaara et           186     Mixed/no/no/NR         39.1
  al, (15) 1995

Marchand et al, (60)     48     NR/NR/no/NR            35.1 (7.8)
  1993

Martin et al, (43)       36     Mixed/No/NR/NR         39
  1986

Mathews and              27     All/all/?/NR           44
  Hickling, (33)
  1975

Moffett et al, (30)     187     NR/NR/NR/NR            42.6 (8.6)
  1999

Moore and                28     NR/NR/NR/mixed         52
  Shurman, (61)
  1997

Moret et al, (27)        16     All/all/all/NR         43.3 (9.0)
  1998

Nouwen and               26     NR/NR/NR/NR            34.5
  Solinger, (73)
  1979

Nouwen, (74) 1983        20     NR/NR/NR/NR            45.5 (9.3)

Nwuga, (28) 1983         73     NR/NR/all/all          43.6

Pal et al, (34) 1986     42     All/NR/NR/NR           38

Pope et al, (124)        94     No/no/no/NR            32
  1994

Reust et al, (124)       60     Mixed/NR/Mixed/NR      55
  1988

Risch et al, (46)        54     Mixed/NR/NR/NR         47
  1993

Roman, (59) 1960         36     Mixed/NR/mixed/NR      No data

Seferlis et al, (16)    180     Mixed/NR/NR/NR         39 (19-64)
  1998

Spratt et al, (44)       56     NR/NR/no/no (included  NR
  1993                            spondylolisthesis)

Sternbach et al, (63)    78     Mixed/NR/NR/NR         NR
  1976

Stuckey et al, (72)      30     Mixed/NR/yes/NR        38.9 (9.4)
  1986

Timm, (76) 1994         200     All/no/no/yes          44.9 (5.1)

van der Heijden          25     Mixed/NR/?/?           47 (8)
  et al, (111) 1995

Weber, (25) 1973         72     All/NR/all/all         30-60

Weber et al, (26)        44     All/NR/all/all         NR
  1984

                       Sample   Symptom
Author/Year            Size     Duration            Treatment

Asfour et al, (70)       30     5.83 (8.45) y       EMG biofeedback-
  1990                                                paraspinal
                                                      contraction

Beurskens and           151     >6 wk               Static traction
  colleagues, (54,55)                                 35%-50% body
  1995, 1997                                            weight

Bush et al, (71)         72     12 y                EMG biofeedback
  1985                                                to reduce
                                                      paraspinal
                                                      muscle tension

Cherkin et al, (31)     226     <6 wk               McKenzie
  1998

Coxhead et al, (58)     322     Mean 14 wk          Intermittent
  1981                                                traction-
                                                      unknown

Davies et al, (32)       47     >3 wk but <6 mo     1. extension
  1979                                              2. Kendall flexion

Dehlin et al, (48)       32     >1 y symptoms       Strength
  1978

Dehlin et al, (49)       45     >6 mo               Aerobics, strength
  1981

Deyo et al, (50)        145     [greater than       1. TENS (C), (A)
  1990                            or equal to]        HF/LF
                                  3 mo, 36-84       2. TENS + exercise
                                  mo                3. placebo TENS +
                                                      stretch

Evans et al, (13)       186     <6 d                Kendall flexion
  1987

Faas and                473     1-7 d               Stretching,
  colleagues, (14,19)                                 strengthening
  1993, 1995                                          exercises

Frost and                81     22 mo               Strengthening,
  colleagues, (45)                                    stretching,
  1995                                                aerobic exercises

Gemignani et             20     [greater than       TENS A, LF 5 Hz
  al., (62) 1991                  or equal to]
                                  1 mo.

Hansen et al, (47)      180     >4 wk               Strengthening
  1993                                                exercises

Herman et al, (29)       58     3-10 wk             TENS C, A, HF
  1994                                                (200 Hz)

Hides et al, (126)       39     <3 wk, 9.16 d       Therapeutic
  1996                                                ultrasound
                                                      biofeedback
                                                      assisted
                                                      multifidus
                                                      muscle
                                                      exercise

Kellett et              125     Unspecified         Strengthening,
  al, (51) 1991                                       stretching,
                                                      aerobic
                                                      exercises,
                                                      education

Kuukkanen and            86     7 wk-6 mo           Strengthening
  Malkia, (101)                                       exercises
  1996

Lidstrom and             62     All >1 mo, 50%      Traction 50% of
  Zachrisson, (56)                > 1 y               body weight,
  1970                                                intermittent

Malmivaara et           186     <3 wk               Extension, lateral
  al, (15) 1995                                       bend,
                                                      (unsupervised)

Marchand et al, (60)     48     >6 mo mean 6.51     TENS C, HF (100
  1993                            (6.22) y            Hz)

Martin et al, (43)       36     >6 wk               1. Stretching +
  1986                                                strengthening
                                                      exercises
                                                    2. Isometric
                                                      strengthening +
                                                      Kendall flexion
                                                      exercises

Mathews and              27     Mean 14 wk          Static traction
  Hickling, (33)                                      36-61 kg
  1975

Moffett et al, (30)     187     4 wk-6 mo           Strengthening,
  1999                                                stretching,
                                                      aerobic
                                                      exercises

Moore and                28     [greater than       1. NMES
  Shurman, (61)                   or  equal         2. TENS C, HF 100
  1997                            to] 6 mo            Hz + NMES
                                  (mean             3. TENS C, HF 100
                                  3.83 y)             Hz

Moret et al, (27)        16     NR, hospitalized    Vertical traction
  1998

Nouwen and               26     >6 mo, 6.3 y        EMG biofeedback-
  Solinger, (73)                                      paraspinal
  1979                                                contraction

Nouwen, (74) 1983        20     >6 mo, 11.8 y       EMG biofeedback-
                                                      paraspinal
                                                      relaxation

Nwuga, (28) 1983         73     Acute <2 wk         Therapeutic
                                                      ultrasound (type
                                                      unspecified)

Pal et al, (34) 1986     42     Mean 6-8 wk         Continuous traction
                                                      5.5-8.2 kg

Pope et al, (124)        94     3 wk-6 mo           NMES
  1994

Reust et al, (124)       60     Unspecified         1. Continuous
  1988                                                traction 50 kg
                                                    2. Mild continuous
                                                      traction 15 kg

Risch et al, (46)        54     Unspecified         Strengthening
  1993                                                exercises

Roman, (59) 1960         36     NR                  Continous
                                                      ultrasound

Seferlis et al, (16)    180     <2 wk               Strengtening
  1998                                                exercises

Spratt et al, (44)       56     4 wk-5 y            1. Flexion brace +
  1993                                                Kendall
                                                      exercises
                                                    2. Extension brace
                                                      + McKenzie
                                                      exercises

Sternbach et al, (63)    78     [greater than or    1. TENS
  1976                            equal to]         2. Postsurgery
                                  6 mo                TENS

Stuckey et al, (72)      30     >6 mo               EMG biofeedback-
  1986                                                paraspinal and
                                                      trapezius muscle
                                                      relaxation

Timm, (76) 1994         200     At least 1 y        1. Strengthening +
                                  postlaminectomy     aerobic
                                                      exercises
                                                    2. McKenzie,
                                                      strengthening
                                                      exercises
                                                    3. Hot pack,
                                                      therapeutic
                                                      ultrasound, TENS

van der Heijden          25     >3 mo               Static traction
  et al, (111) 1995                                   44% of body
                                                      weight

Weber, (25) 1973         72     Unspecified,        Traction
                                  hospitalized        intermittent,
                                                      33% of body
                                                      weight

Weber et al, (26)        44     Unspecified,        Intermittent
  1984                            hospitalized        traction,
                                                      40-70 kps

                       Sample   Comparison             Concurrent
Author/Year            Size     Group                  Therapy

Asfour et al, (70)       30     No treatent            Pain program
  1990

Beurskens and           151     Placebo traction,      Analgesics,
  colleagues, (54,55)             20% of body            pamphlet
  1995, 1997                      weight

Bush et al, (71)         72     Asked to relax         Practice
  1985                            paraspinal             strategy at
                                  muscles, but not       home 4 x/d
                                  given
                                  biofeedback

Cherkin et al, (31)     226     Education booklet      None
  1998

Coxhead et al, (58)     322     Corset                 SWD, lecture
  1981

Davies et al, (32)       47     Untreated              SWD
  1979

Dehlin et al, (48)       32     1. Untreated           None
  1978                          2. Education

Dehlin et al, (49)       45     Untreated              None
  1981

Deyo et al, (50)        145     Sham TENS              Heat,
  1990                                                   education

Evans et al, (13)       186     Untreated              Analgesics/
  1987                                                   education

Faas and                473     1. Untreated           Analgesics,
  colleagues, (14,19)           2. Placebo               information
  1993, 1995                      ultrasound

Frost and                81     Untreated              Back school
  colleagues, (45)
  1995

Gemignani et             20       Placebo TENS         NSAIDS
  al., (62) 1991                                         discontinued,
                                                         analgesics
                                                         allowed

Hansen et al, (47)      180     Placebo (semi hot      None
  1993                            pack, 10% body
                                  weight traction)

Herman et al, (29)       58     Sham TENS              Stretching,
  1994                                                   strengthening,
                                                         aerobic
                                                         exercises

Hides et al, (126)       39     No treatment           Bed rest 1-3
  1996                                                   d, minor
                                                         analgesics

Kellett et              125     Untreated              None
  al, (51) 1991

Kuukkanen and            86     Untreated              Allowed to see
  Malkia, (101)                                          physical
  1996                                                   therapist

Lidstrom and             62     Hot pack, rest         None
  Zachrisson, (56)
  1970

Malmivaara et           186     1. Bed rest            Anti-
  al, (15) 1995                 2. Normal activities     inflammatory
                                                         analgesics

Marchand et al, (60)     48     1. Placebo TENS        None
  1993                          2. Waiting list
                                  controls

Martin et al, (43)       36     Placebo ultrasound,    Handout on
  1986                            placebo SWD,           back care
                                  heat

Mathews and              27     Placebo traction       None
  Hickling, (33)                  maximum 9.1 kg
  1975

Moffett et al, (30)     187     General practitioner   None
  1999

Moore and                28     Sham TENS              Normal routine
  Shurman, (61)                                          and pain
  1997                                                   medication

Moret et al, (27)        16     Untreated              Analgesic
  1998                                                   diary, bed
                                                         rest for 1-2
                                                         wk

Nouwen and               26     Waiting list           Refrain from
  Solinger, (73)                  controls               medication
  1979

Nouwen, (74) 1983        20     Waiting list controls  None

Nwuga, (28) 1983         73     1. Placebo             Bed rest,
                                  ultrasound             analgesics
                                2. Untreated

Pal et al, (34) 1986     42     Placebo traction       None
                                  1.4-1.8 kg

Pope et al, (124)        94     Corset                 None
  1994

Reust et al, (124)       60     Placebo traction       Bed rest,
  1988                            5 kg                   NSAIDs,
                                                         diazapam,
                                                         massage
                                                         daily

Risch et al, (46)        54     Untreated (waiting     Training
  1993                            list)                  techniques
                                                         re dynamic
                                                         resistance

Roman, (59) 1960         36     Placebo ultrasound     Heat,
                                                         mobilization
                                                         exercises

Seferlis et al, (16)    180     General practitioner   None
  1998

Spratt et al, (44)       56     Placebo brace,         Videotape
  1993                            walking if desired     appropriate
                                                         to assigned
                                                         treatment

Sternbach et al, (63)    78     1. Untreated           Allowed
  1976                          2. Postsurgery no        analgesics
                                  TENS

Stuckey et al, (72)      30     Placebo setup,         None
  1986                            no instructions

Timm, (76) 1994         200       Untreated            None

van der Heijden          25     Placebo traction       None
  et al, (111) 1995               19% of body
                                  weight

Weber, (25) 1973         72     Placebo traction,      None
                                  up to 7 kps

Weber et al, (26)        44     Placebo traction,      Analgesics
  1984                            0 kg

                       Sample   Treatment        Follow-up
Author/Year            Size     Schedule         (wk)

Asfour et al, (70)       30     5 x/wk for       2
  1990                          1.5 wk

Beurskens and           151     2 x/wk for 5     12, 26
  colleagues, (54,55)             wk
  1995, 1997

Bush et al, (71)         72     8 sessions       3 mo
  1985                            minimum

Cherkin et al, (31)     226     2 x/wk for 4     12, 52, 104
  1998                            wk

Coxhead et al, (58)     322     Daily for 4 wk   16
  1981

Davies et al, (32)       47     4 wk             None
  1979

Dehlin et al, (48)       32     2 x/wk for 8     None
  1978                            wk

Dehlin et al, (49)       45     2 x/wk for 8     8
  1981                            wk

Deyo et al, (50)        145     TENS--3 x/d      12
  1990                            for 2 wk
                                  Exercise--
                                  daily at
                                  home, visits
                                  2 x/wk for
                                  4 wk

Evans et al, (13)       186     8 wk             12, 52
  1987

Faas and                473     2 x/wk for 5     52
  colleagues, (14,19)             wk
  1993, 1995

Frost and                81     2 x/wk for 4     24
  colleagues, (45)                wk
  1995

Gemignani et             20     1 x/wk for 3     None
  al., (62) 1991                  wk

Hansen et al, (47)      180     2 x/wk for 4     4, 24, 52
  1993                            wk

Herman et al, (29)       58     1-3 x/wk for     None
  1994                            4 wk

Hides et al, (126)       39     4 wk             10
  1996

Kellett et              125     1 x/wk for 72    72
  al, (51) 1991                   wk

Kuukkanen and            86     2 x/wk for 12    24, 52
  Malkia, (101)                   wk
  1996

Lidstrom and             62     2-3 x/wk for     None
  Zachrisson, (56)                4 wk
  1970

Malmivaara et           186     1 set/2 h until  4, 12
  al, (15) 1995                   pain
                                  subsides

Marchand et al, (60)     48     2 x/wk for 10    12, 26
  1993                            wk

Martin et al, (43)       36      3               None
  1986

Mathews and              27     5 x/wk for 3     6
  Hickling, (33)                  wk
  1975

Moffett et al, (30)     187     2 x/wk for 4     6, 24, 52
  1999                            wk

Moore and                28     5 h/d for 2 d    None
  Shurman, (61)
  1997

Moret et al, (27)        16     4-6 x/d for      None
  1998                            1-2 wk

Nouwen and               26     5 x/wk for 4     6, 12
  Solinger, (73)                  wk
  1979

Nouwen, (74) 1983        20     5 x/wk for 3     6
                                  wk

Nwuga, (28) 1983         73     3 x/wk for 4     None
                                  wk

Pal et al, (34) 1986     42     NR for 3 wk      1, 2, 3, 4,
                                                 6, 104

Pope et al, (124)        94     8 h/d for 3      None
  1994                            wk

Reust et al, (124)       60     Daily for 2 wk   None
  1988

Risch et al, (46)        54     2 for 4 wk,      None
  1993                            1 for 6 wk

Roman, (59) 1960         36     3 x/wk for 2     NR
                                  wk

Seferlis et al, (16)    180     3 x/wk for 8     12, 52
  1998                            wk

Spratt et al, (44)       56     NR               4
  1993

Sternbach et al, (63)    78     NR               52
  1976

Stuckey et al, (72)      30     8 sessions       None
  1986

Timm, (76) 1994         200     3 x/wk for 8     104
                                  wk

van der Heijden          25     3 x/wk for 4     5, 9
  et al, (111) 1995               wk

Weber, (25) 1973         72     Daily for 1 wk   None

Weber et al, (26)        44     Daily for 1 wk   NR
  1984

                       Sample   Quality (11,12)
Author/Year            Size     (R, B, W)

Asfour et al, (70)       30     1, 0, 0
  1990

Beurskens and           151     2, 2, 1
  colleagues, (54,55)
  1995, 1997

Bush et al, (71)         72     1, 1, 1
  1985

Cherkin et al, (31)     226     2, 0, 1
  1998

Coxhead et al, (58)     322     1, 0, 1
  1981

Davies et al, (32)       47     1, 0, 0
  1979

Dehlin et al, (48)       32     0, 0, 1
  1978

Dehlin et al, (49)       45     0, 0, 1
  1981

Deyo et al, (50)        145     2, 2, 1
  1990

Evans et al, (13)       186     0, 0, 1
  1987

Faas and                473     2, 0, 1
  colleagues, (14,19)
  1993, 1995

Frost and                81     1, 0, 10
  colleagues, (45)
  1995

Gemignani et             20     0, 1,
  al., (62) 1991

Hansen et al, (47)      180     1, 2, 1
  1993

Herman et al, (29)       58     2, 2, 1
  1994

Hides et al, (126)       39     2, 0, 1
  1996

Kellett et              125     1, 0, 1
  al, (51) 1991

Kuukkanen and            86     0, 0, 0
  Malkia, (101)
  1996

Lidstrom and             62     1, 0, 0
  Zachrisson, (56)
  1970

Malmivaara et           186     2, 0, 1
  al, (15) 1995

Marchand et al, (60)     48     1, 0, 0
  1993

Martin et al, (43)       36     0, 0, 1
  1986

Mathews and              27     1, 1, 0
  Hickling, (33)
  1975

Moffett et al, (30)     187     2, 0, 0
  1999

Moore and                28     1, 1, 1
  Shurman, (61)
  1997

Moret et al, (27)        16     2, 0, 1
  1998

Nouwen and               26     0, 0, 1
  Solinger, (73)
  1979

Nouwen, (74) 1983        20     1, 0, 0

Nwuga, (28) 1983         73     0, 0, 0

Pal et al, (34) 1986     42     1, 0, 1

Pope et al, (124)        94     2, 0, 0
  1994

Reust et al, (124)       60     2, 2, 1
  1988

Risch et al, (46)        54     2, 0, 0
  1993

Roman, (59) 1960         36     0, 0, 0

Seferlis et al, (16)    180     1, 0, 1
  1998

Spratt et al, (44)       56     1, 0, 1
  1993

Sternbach et al, (63)    78     NA (obser-
  1976                            vational
                                  study)

Stuckey et al, (72)      30     1, 0 1
  1986

Timm, (76) 1994         200     1, 0, 1

van der Heijden          25     2, 0, 1
  et al, (111) 1995

Weber, (25) 1973         72     1, 0, 1

Weber et al, (26)        44     1, 0, 1
  1984

(a) R=randomization, B=blinding, W=Withdrawals, LBP=low back pain,
SLR=straight leg raise, NA=not available, NR=not reported,
EMG=electromyographic, TENS=transcutaneous electrical nerve
stimulation (A=acupuncture-like TENS, C=conventional TENS),
HF=high frequency, LF=low frequency, NSAID=nonsteroidal
anti-inflammatory drug, SWD=shortwave diathermy, NMES=neuromuscular
electrical stimulation.
Table 1.

Details of Philadelphia Panel Classification System

                                  Statistical
           Clinical Importance    Significance

Grade A    >15%                   P<.05
Grade B    >15%                   P<.05
Grade C+   >15%                   Not significant
Grade C    <15%                   Unimportant (b)
Grade D    <0% (favors control)

           Study Design (a)

Grade A    RCT (single or meta-analysis)
Grade B    CCT or observational (single or meta-analysis), with a
             quality score of 3 or more on the 5-point Jadad
             methodologic quality checklist
Grade C+   RCT or CCT or observational (single or meta-analysis)
Grade C    Any study design
Grade D    Well-designed RCT with >100 patients

(a) RCT=randomized controlled trial, CCT=controlled clinical trial.

(b) For grade C, statistical significance is unimportant (ie,
clinical importance is not met; therefore, statistical significance
is irrelevant).
Table 2.

Master Grid of Low Back Pain (LBP) Guidelines (a)

                         Acute           Subacute
                         LBP             LBP

Exercise                 [check] C, I    [check] A, I
Continue normal          [check] A, I    ID
  activities
Traction                 [check] C, I    [check] C, I
Therapeutic ultrasound   [check] C, II   nd
TENS                     [check] C, I    nd
Massage                  ID              nd
Thermotherapy            nd              nd
Electrical stimulation   nd              nd
EMG biofeedback          ID              nd
Combined rehabilitation  ID              nd
  interventions

                                         Post-
                         Chronic         surgery
                         LBP             LBP

Exercise                 [check] A, I    [check] A, I
Continue normal          ID              ID
  activities
Traction                 [check] C, I    nd
Therapeutic ultrasound   [check] C, II   nd
TENS                     [check] C, I    nd
Massage                  ID              nd
Thermotherapy            ID              nd
Electrical stimulation   ID              nd
EMG biofeedback          [check] C, I    nd
Combined rehabilitation  ID              nd
  interventions

(a) TENS=transcutaneous electrical nerve stimulation,
EMG=electromyographic, nd=no data, ID=insufficient data, A=benefit
demonstrated, C=no benefit demonstrated, level I=randomized controlled
trial evidence, level II=evidence from controlled clinical trials.
Table 3.

Grade A Guidelines: Clinically Important Benefit Demonstrated (a)

Guideline                     Recommendation  Outcomes        Relative
                                                              Difference

Continue normal activity      Grade A, I      Sick leave,     3.5 d (49%
  versus enforced                               12 wk         differ-
  bed rest for                                                ence)
  acute (<4 wk) low           Grade C         Function, 3,    10%
  back pain                                     12 wk
                              Grade C         Pain            10%

Therapeutic exercises for     Grade A         Pain            10%-57%
  subacute (4-12 wk) low      Grade A         Function        11-15%
  back pain                   Grade A         Patient global  17-24%
                                              assessment

Therapeutic exercises for     Grade A         Pain            18%-60%
  chronic (>12 wk) low back   Grade A         Function        7%-47%
  pain

Therapeutic exercises for     Grade A         Function        51%-56%
  back pain postsurgery

Guideline                     Recommendation  Outcomes        Study
                                                              Design

Continue normal activity      Grade A, I      Sick leave,     RCT (N=
  versus enforced bed rest                      12 wk           186)
  for acute (<4 wk) low       Grade C         Function, 3,
  back pain                                     12 wk
                              Grade C         Pain
Therapeutic exercises for     Grade A         Pain            3 RCTs
  subacute (4-12 wk) low                                     (N=405)
  back pain                   Grade A         Function
                              Grade A         Patient global
                                              assessment
Therapeutic exercises for     Grade A         Pain            6 RCTs
  chronic (>12 wk) low back   Grade A         Function          (N=563)
  pain
Therapeutic exercises for     Grade A         Function        1 RCT
  back pain postsurgery                                         (N=200)

(a) RCT=randomized controlled trial.
Table 4.

Grade C Rehabilitation Interventions: Clinically Important Benefit
Not Demonstrated (a)

                                                       Relative
Guideline              Recommendation  Outcome         Difference

Therapeutic exercises  Grade C         Pain            No effect
  versus control for   Grade C         Function
  acute low back pain  Grade C         Return to
                                         work

Mechanical traction    Grade C         Pain            No effect
  for acute low back
  pain

Ultrasound for acute   Grade C         Pain            No effect
  low back pain

TENS for acute low     Grade C         Pain            No effect
  back pain
                       Grade C         Function

Mechanical traction    Grade C         Pain            No effect
  for subacute low     Grade C         Patient
  back pain (4-12 wk)                    global
                                         assessment
                       Grade C         Return to work

Mechanical traction    Grade C         Pain            No effect
  for chronic low      Grade C         Function
  back pain
                       Grade C         Return to work

Therapeutic            Grade C         Pain            No effect
  ultrasound for
  chronic low
  back pain

TENS for chronic low   Grade C         Pain            No effect
  back pain
                       Grade C         Function

EMG biofeedback for    Grade C         Pain             -3% to 50%
  chronic low back     Grade C         Function
  pain

Guideline              Recommendation  Outcome         Study Design

Therapeutic exercises  Grade C         Pain            4 RCTs (N=549)
  versus control for   Grade C         Function
  acute low back pain  Grade C         Return to
                                         work

Mechanical traction    Grade C         Pain            3 RCTs (N=176)
  for acute low back
  pain

Ultrasound for acute   Grade C         Pain            1 CCT (N=73)
  low back pain

TENS for acute low     Grade C         Pain            1 RCT (N=58)
  back pain
                       Grade C         Function

Mechanical traction    Grade C         Pain            3 RCTs (N=212)
  for subacute low     Grade C         Patient
  back pain (4-12 wk)                    global
                                         assessment
                       Grade C         Return to work

Mechanical traction    Grade C         Pain            2 RCTs (N= 176)
  for chronic low      Grade C         Function
  back pain
                       Grade C         Return to work

Therapeutic ultrasound Grade C         Pain            1 CCT (N=36)
  for chronic low
  back pain

TENS for chronic low   Grade C         Pain            5 RCTs (N=317)
  back pain
                       Grade C         Function
EMG biofeedback for    Grade C         Pain            4 RCTs (N=96)
  chronic low back     Grade C         Function
  pain

(a) RCT=randomized controlled trial, CCT=controlled clinical trial,
TENS=transcutaneous electrical nerve stimulation,
EMG=electromyography.
Table 5.

Rehabilitation Interventions With Insufficient Data (a)

Intervention and Indication        Details

EMG biofeedback for acute
  nonspecific LBP                  No relevant outcome, or poorly
                                     defined diagnosis or
                                     inappropriate intervention.
                                     One RCT (N=39) with no
                                     relevant outcomes (range of
                                     motion only).

Combined rehabilitation
  interventions for chronic LBP    No relevant outcome, or poorly
                                     defined diagnosis or
                                     inappropriate intervention.
                                     Types of intervention poorly
                                     defined and not comparable to
                                     each other.

Massage for acute LBP              No evidence from
                                     placebo-controlled RCT or CCT.
                                     One comparative trial
                                     compared massage with "faradic
                                     current."

Massage for chronic LBP            No evidence from placebo-controlled
                                     RCT or CCT. Subjects wearing
                                     corset (124) were considered an
                                     inappropriate control group.
                                     Evidence from an unpublished
                                     abstract by Cherkin et al (75)
                                     suggests that massage may be
                                     beneficial.

Thermotherapy for chronic LBP      No evidence from placebo-controlled
                                     RCT or CCT.

Electrical stimulation for
  chronic LBP                      No evidence from placebo-controlled
                                     RCT or CCT. Subjects wearing
                                     corset (124) were considered an
                                     inappropriate control group.

(a) EMG=electromyographic, LBP=low back pain, RCT=randomized controlled
trial, CCT=controlled clinical trial.
Table 6.

Continue Normal Activities for Acute Low Back Pain: Pain, Function,
and Return to Work at 3 Weeks (a)

                        Treatment            Outcome       No. of
Study                   Group                (Units)       Patients

Malmivaara et al, (15)  E: normal activity   Return to     67
  1995                  C: bed rest            work (d)    67

Malmivaara et al, (15)  E: normal activity   Function,     67
  1995                  C: bed rest            Oswestry    67
                                               scale
                                               (0-100)

Malmivaara et al, (15)  E: normal activity   Pain, VAS 10  67
  1995                  C: bed rest            cm          67

                        Treatment            Outcome       Baseline
Study                   Group                (Units)       Mean

Malmivaara et al, (15)  E: normal activity   Return to     NA
  1995                  C: bed rest            work (d)    NA

Malmivaara et al, (15)  E: normal activity   Function,     32
  1995                  C: bed rest            Oswestry    34.6
                                               scale
                                               (0-100)

Malmivaara et al, (15)  E: normal activity   Pain, VAS     5.7
  1995                  C: bed rest            10 cm       5.9

                        Treatment           Outcome       End-of-Study
Study                   Group               (Units)          Mean

Malmivaara et al, (15)  E: normal activity  Return to       4.1
  1995                  C: bed rest           work (d)      7.5

Malmivaara et al, (15)  E: normal activity  Function,      10
  1995                  C: bed rest           Oswestry     16
                                              scale
                                              (0-100)

Malmivaara et al, (15)  E: normal activity  Pain, VAS       1.9
  1995                  C: bed rest           10 cm         2.4

                        Treatment            Outcome
Study                   Group                (Units)       Absolute
                                                           Benefit

Malmivaara et al, (15)  E: normal activity   Return to     3.4 (I) d
  1995                  C: bed rest            work (d)      difference
                                                             after 3 wk

Malmivaara et al, (15)  E: normal activity   Function,     -3.40 (I) on
  1995                  C: bed rest            Oswestry      100-point
                                               scale         scale
                                               (0-100)

Malmivaara et al, (15)  E: normal activity   Pain, VAS 10  -0.30 (I) on
  1995                  C: bed rest            cm            10-cm VAS

                                                           Relative
                                                           Difference
                                                           in Change
                        Treatment            Outcome       From
Study                   Group                (Units)       Baseline

Malmivaara et al, (15)  E: normal activity   Return to     49% (I)
  1995                  C: bed rest            work (d)

Malmivaara et al, (15)  E: normal activity   Function,     -10% (I)
  1995                  C: bed rest            Oswestry
                                               scale        -5% (I)
                                               (0-100)

Malmivaara et al, (15)  E: normal activity   Pain, VAS
  1995                  C: bed rest            10 cm

(a) E=exercise group, C=control group, NA=not available, VAS=visual
analog scale.
Table 7.

Therapeutic Exercises for Subacute Low Back Pain: Pain at 1 Month (a)

                                                      No. of
Study       Treatment Group    Outcome (Scale)        Patients

Cherkin et  E: McKenzie        Pain, bothersomeness,  129
  al, (31)    exercises          0-10                  65
  1998      C: control
Davies et   E1: McKenzie       Pain, 0-10 cm VAS       14
  al, (32)    exercises
  1979      E2: Kendall                                14
              exercises
            C: control                                 15
Moffett et  E: strengthening,  Pain, Aberdeen          89
  al, (30)    aerobic,           scale
  1999        stretching
              exercises
            C: control                                 98
Cherkin et  E: McKenzie        Function, Roland       129
  al, (31)    exercises          scale 0-23
  1998      C: control                                 65
Moffett et  E: strengthening,  Function, Roland        89
  al, (30)    aerobic,           scale 0-23
  1999        stretching
              exercises
            C: control                                 98

                                                      Baseline
Study       Treatment Group    Outcome (Scale)        Mean

Cherkin et  E: McKenzie        Pain, bothersomeness,   6
  al, (31)    exercises          0-10                  5.3
  1998      C: control
Davies et   E1: McKenzie       Pain, 0-10 cm VAS      11.2
  al, (32)    exercises
  1979      E2: Kendall                                7.3
              exercises
            C: control                                 8.7
Moffett et  E: strengthening,  Pain, Aberdeen         27.93
  al, (30)    aerobic,           scale
  1999        stretching
              exercises
            C: control                                25.52
Cherkin et  E: McKenzie        Function, Roland       12.2
  al, (31)    exercises          scale 0-23           11.7
  1998      C: control
Moffett et  E: strengthening,  Function, Roland        6.65
  al, (30)    aerobic,           scale 0-23
  1999        stretching
              exercises
            C: control                                 5.56

                                                      End-of-
                                                      Study
Study       Treatment Group    Outcome (Scale)        Mean

Cherkin et  E: McKenzie        Pain, bothersomeness,      2.3
  al, (31)    exercises          0-10                     4.9
  1998      C: control
Davies et   E1: McKenzie       Pain, 0-10 cm VAS          1.8
  al, (32)    exercises
  1979      E2: Kendall                                   1.3
              exercises
            C: control                                    3.7
Moffett et  E: strengthening,  Pain, Aberdeen            16.35
  al, (30)    aerobic,           scale
  1999        stretching
              exercises
            C: control                                   16.53
Cherkin et  E: McKenzie        Function, Roland           4.1
  al, (31)    exercises          scale 0-23               4.9
  1998      C: control
Moffett et  E: strengthening,  Function, Roland           3.79
  al, (30)    aerobic,           scale 0-23
  1999        stretching
              exercises
            C: control                                    3.62

Study       Treatment Group    Outcome (Scale)        Absolute Benefit

Cherkin et  E: McKenzie        Pain, bothersomeness,  -3.30 (I) on
  al, (31)    exercises          0-10                   10-point scale
  1998      C: control
Davies et   E1: McKenzie       Pain, 0-10 cm VAS      -4.4 (I) on 10-cm
  al, (32)    exercises                                 VAS
  1979      E2: Kendall                               -1.0 (I) on 10-cm
              exercises                                 VAS
            C: control
Moffett et  E: strengthening,  Pain, Aberdeen         -2.59 (I)
  al, (30)    aerobic,           scale
  1999        stretching
              exercises
            C: control
Cherkin et  E: McKenzie        Function, Roland       -1.30 (I) on
  al, (31)    exercises          scale 0-23             23-point scale
  1998      C: control
Moffett et  E: strengthening,  Function, Roland       -0.92 (I) on
  al, (30)    aerobic,           scale 0-23             23-point scale
  1999        stretching
              exercises
            C: control

                                                      Relative
                                                      Difference
                                                      in Change
                                                      from
Study       Treatment Group    Outcome (Scale)        Baseline

Cherkin et  E: McKenzie        Pain, bothersomeness,  -57% (I)
  al, (31)    exercises          0-10
  1998      C: control
Davies et   E1: McKenzie       Pain, 0-10 cm VAS      -50% (I)
  al, (32)    exercises
  1979      E2: Kendall                               -11% (I)
              exercises
            C: control
Moffett et  E: strengthening,  Pain, Aberdeen         -10% (I)
  al, (30)    aerobic,           scale
  1999        stretching
              exercises
            C: control
Cherkin et  E: McKenzie        Function, Roland       -11% (I)
  al, (31)    exercises          scale 0-23
  1998      C: control
Moffett et  E: strengthening,  Function, Roland       -15% (I)
  al, (30)    aerobic,           scale 0-23
  1999        stretching
              exercises
            C: control

(a) E=exercise group, C=control group, VAS=visual analog scale.
Table 8.

Therapeutic Exercises for Subacute Low Back Pain: Patient Global
Assessment at 1 Month (a)

                                                        No.
Study           Treatment Group         Outcome         Improved

Davies et       E1: McKenzie exercises  Patient global  9
  al, (32)      E2: Kendall exercises     assessment    8
  1979          C: control                              6

                                                        No. of
Study           Treatment Group         Outcome         Patients

Davies et       E1: McKenzie exercises  Patient global  14
  al, (32)      E2: Kendall exercises     assessment    14
  1979          C: control                              15

                                                        Risk (% of
Study           Treatment Group         Outcome         Occurrence)

Davies et       E1: McKenzie exercises  Patient global  64%
  al, (32)      E2: Kendall exercises     assessment    57%
  1979          C: control                              40%

                                                        Risk
Study           Treatment Group         Outcome         Difference

Davies et       E1: McKenzie exercises  Patient global  24%
  al, (32)      E2: Kendall exercises     assessment    17%
  1979          C: control

(a) E=exercise group, C=control group.
Table 9.

Therapeutic Exercises for Chronic Low Back Pain: Pain at 1 Month (a)

                                                           No. of
Study            Treatment Group         Outcome (Scale)   Patients

Frost et         E: strengthening,       Sensory pain      36
  al, (45) 1995    stretching, aerobic     (0-100 VAS)
                   exercises
                 C: control                                35
Deyo et          E: stretching           Pain improvement  63
  al, (50) 1990    exercises               (0-100)
                 C: control                                63
Spratt et        E: McKenzie             Pain (0-10 cm     21
  al, (44) 1993    exercise                VAS)
                 C: control                                17
Hansen et        E: strengthening        Pain (0-9 VAS)    44
  al, (47) 1993   exercises
                 C: control                                28
Risch et         E: strengthening,       Pain (West-Haven  31
  al, (46) 1993    stretching exercises    Yale scale,
                                           0-25)
                 C: control                                23

                                                           Baseline
Study            Treatment Group         Outcome (Scale)   Mean

Frost et         E: strengthening,       Sensory pain      20.9
  al, (45) 1995    stretching, aerobic     (0-100 VAS)
                   exercises
                 C: control                                25.6
Deyo et          E: stretching           Pain improvement  NA
  al, (50) 1990    exercises               (0-100)
                 C: control                                NA
Spratt et        E: McKenzie             Pain (0-10 cm      5.6
  al, (44) 1993    exercise                VAS)
                 C: control                                 5.84
Hansen et        E: strengthening        Pain (0-9 VAS)     5.0
  al, (47) 1993   exercises
                 C: control                                 5.0
Risch et         E: strengthening,       Pain (West-Haven   3.4
  al, (46) 1993    stretching exercises    Yale scale,
                                           0-25)
                 C: control                                 3.7

                                                           End-of-
                                                           Study
Study            Treatment Group         Outcome (Scale)   Mean

Frost et         E: strengthening,       Sensory pain        12.1
  al, (45) 1995    stretching, aerobic     (0-100 VAS)
                   exercises
                 C: control                                  22.1
Deyo et          E: stretching           Pain improvement    47.9
  al, (50) 1990    exercises               (0-100)
                 C: control                                  40.9
Spratt et        E: McKenzie             Pain (0-10 cm        6.85
  al, (44) 1993    exercise                VAS)
                 C: control                                   5.97
Hansen et        E: strengthening        Pain (0-9 VAS)       4.1
  al, (47) 1993   exercises
                 C: control                                   7.1
Risch et         E: strengthening,       Pain (West-Haven     2.9
  al, (46) 1993    stretching exercises    Yale scale,
                                           0-25)
                 C: control                                   4.1

                                                           Absolute
Study            Treatment Group         Outcome (Scale)   Benefit

Frost et         E: strengthening,       Sensory pain      -5.30 (I) on
  al, (45) 1995    stretching, aerobic     (0-100 VAS)       100-point
                   exercises                                 VAS
                 C: control
Deyo et          E: stretching           Pain improvement  +7 (I) on
  al, (50) 1990    exercises               (0-100)           100-point
                                                             scale
                 C: control
Spratt et        E: McKenzie             Pain (0-10 cm     -1.12 (I) on
  al, (44) 1993    exercise                VAS)              10-cm VAS
                 C: control
Hansen et        E: strengthening        Pain (0-9 VAS)    -3.00 (I) on
  al, (47) 1993   exercises                                  9-point
                                                             Likert
                                                             scale
                 C: control
Risch et         E: strengthening,       Pain (West-Haven  -0.90 (I) on
  al, (46) 1993    stretching exercises    Yale scale,       25-point
                                           0-25)             scale
                 C: control

                                                           Relative
                                                           Difference
                                                           in Change
                                                           From
Study            Treatment Group         Outcome (Scale)   Baseline

Frost et         E: strengthening,       Sensory pain      -23% (I)
  al, (45) 1995    stretching, aerobic     (0-100 VAS)
                   exercises
                 C: control
Deyo et          E: stretching           Pain improvement  +7% (I)
  al, (50) 1990    exercises               (0-100)
                 C: control
Spratt et        E: McKenzie             Pain (0-10 cm     -20% (I)
  al, (44) 1993    exercise                VAS)
                 C: control
Hansen et        E: strengthening        Pain (0-9 VAS)    -60% (I)
  al, (47) 1993   exercises
                 C: control
Risch et         E: strengthening,       Pain (West-Haven  -26% (I)
  al, (46) 1993    stretching exercises    Yale scale,
                                           0-25)
                 C: control

(a) E=exercise group; C=control group; VAS=visual analog scale;
NA=not available; (I) indicates improvement better in treatment group
than in control group, negative or positive depending on anchors for
the scales.
Table 10.

Therapeutic Exercises for Chronic Low Back Pain: Function After 1
Month (a)

                                                       No. of
Study            Treatment Group   Outcome             Patients

Deyo et          E: stretching     Function: modified  63
  al, (50) 1990    exercises         SIP score (0-
                                     100
                                     100=worst)
                 C: control                            62
Frost et         E: strengthening, Disability:         36
  al, (45) 1995    stretching,       Oswestry scale
                   aerobic           (0-100,
                   exercises         100=worst)
                 C: control                            35
Risch et         E: strengthening, SIP, physical       31
  al, (46) 1993    stretching        component (0-
                   exercises         100
                                     100=worst)
                 C: control                            23

                                                         Baseline
Study            Treatment Group   Outcome               Mean

Deyo et          E: stretching     Function: modified      10.1
  al,(50) 1990     exercises         SIP score (0-
                                     100
                                     100=worst)
                 C: control                                10.1
Frost et         E: strengthening, Disability:             23.6
  al, (45) 1995    stretching,       Oswestry scale
                   aerobic           (0-100,
                   exercises         100=worst)
                 C: control                                23.6
Risch et         E: strengthening, SIP, physical            9.1
  al, (46) 1993    stretching        component (0-
                   exercises         100
                                     100=worst)
                 C: control                                15.2

                                                         End-of-
                                                         Study
Study            Treatment Group   Outcome               Mean

Deyo et          E: stretching     Function: modified       5.6
  al, (50) 1990    exercises         SIP score (0-
                                     100
                                     100=worst)
                 C: control                                 6.3
Frost et         E: strengthening, Disability:             17.6
  al, (45) 1995    stretching,       Oswestry scale
                   aerobic           (0-100,
                   exercises         100=worst)
                 C: control                                21.7
Risch et         E: strengthening, SIP, physical            7.7
  al, (46) 1993    stretching        component (0-
                   exercises         100
                                     100=worst)
                 C: control                                19.3

                                                       Absolute
                                                       Change
                                                       as % of
Study            Treatment Group   Outcome             Baseline

Deyo et          E: stretching     Function: modified  -45% (I)
  al, (50) 1990    exercises         SIP score (0-
                                     100
                                     100=worst)
                 C: control                            -38% (I)
Frost et         E: strengthening, Disability:         -25% (I)
  al, (45) 1995    stretching,       Oswestry scale
                   aerobic           (0-100,
                   exercises         100=worst)
                 C: control                             -8% (I)
Risch et         E: strengthening, SIP, physical       -15% (I)
  al, (46) 1993    stretching        component (0-
                   exercises         100
                                     100=worst)
                 C: control                            27% (W)

                                                       Difference
                                                       in
                                                       Absolute
Study            Treatment Group   Outcome             Change

Deyo et          E: stretching     Function: modified  -0.70 (I) on
  al, (50) 1990    exercises         SIP score (0-       100-point
                                     100                   scale
                                     100=worst)
                 C: control                            -4.10 (I) on
Frost et         E: strengthening, Disability:           100-point
  al, (45) 1995    stretching,       Oswestry scale      scale
                   aerobic           (0-100,
                   exercises         100=worst)        -5.50 (I) on
                 C: control                              100-point
Risch et         E: strengthening, SIP, physical         scale
  al, (46) 1993    stretching        component (0-
                   exercises         100
                                     100=worst)
                 C: control

                                                       Relative
                                                       % of
Study            Treatment Group   Outcome             Change

Deyo et          E: stretching     Function: modified   -7% (I)
  al, (50) 1990    exercises         SIP score (0-
                                     100
                                     100=worst)
                 C: control
Frost et         E: strengthening, Disability:         -17%(I)
  al, (45) 1995    stretching,       Oswestry scale
                   aerobic           (0-100,
                   exercises         100=worst)
                 C: control
Risch et         E: strengthening, SIP, physical       -47% (I)
  al, (46) 1993    stretching        component (0-
                   exercises         100
                                     100=worst)
                 C: control

(a) E=exercise group, C=control group, SIP=Sickness Impact Profile.
Table 11.

Exercises for Postsurgery Back Pain at 1 Month (a)

                                                        No. of
Study       Treatment Group         Outcome             Patients

Timm, (76)  E1: high-tech resisted  Function: Oswestry  50
  1994        exercises               scale, 0-100
            E2: low-tech, McKenzie                      50
              exercises
            C: control                                  50

                                                         Baseline
Study       Treatment Group         Outcome              Mean

Timm, (76)  E1: high-tech resisted  Function: Oswestry     33.17
  1994        exercises               scale, 0-100
            E2: low-tech, McKenzie                         34.96
              exercises
            C: control                                     37.22

                                                         End-of-
                                                         study
Study       Treatment Group         Outcome              Mean

Timm, (76)  E1: high-tech resisted  Function: Oswestry     15.06
  1994        exercises               scale, 0-100
            E2: low-tech, McKenzie                         14.46
              exercises
            C: control                                     37.04

Study       Treatment Group         Outcome             Absolute Benefit

Timm, (76)  E1: high-tech resisted  Function: Oswestry  -17.93 (I) on
  1994        exercises               scale, 0-100        100-point
                                                          scale
            E2: low-tech, McKenzie                      -20.32 (I) on
              exercises                                   100-point
                                                          scale
            C: control

                                                        Relative
                                                        Difference
                                                        in Change
                                                        From
Study       Treatment Group         Outcome             Baseline

Timm, (76)  E1: high-tech resisted  Function: Oswestry  -51% (I)
  1994        exercises               scale, 0-100
            E2: low-tech, McKenzie                      -56% (I)
              exercises
            C: control

(a) E=exercise group, C=control group.

Acknowledgments: Summer students: Sarah Milne, Michael Saginur, Marie-Josee Noel, Melanie Brophy, Anne Mailhot

Philadelphia Panel Members:

Clinical Specialty Experts:

John Albright, MD (Orthopaedic Surgeon), American Academy of Orthopaedic Surgeons, USA

Richard Allman, MD (Internist, Rheumatologist), American College of Physicians, USA

Richard Paul Bonfiglio, MD (Physiatrist)

Alicia Conill, MD (Internist), University of Pennsylvania, Philadelphia. USA

Bruce Dobkin, MD (Neurologist), American Academy of Neurology, USA

Andrew A Guccione, PT, PhD (Physical Therapist), American Physical Therapy Association, USA

Scott M Hasson, PT, EdD (Physical Therapist), American College of Rheumatology, Association of Health Professionals, USA

Randolph Russo, MD (Physiatrist), American Academy of Physical Medicine and Rehabilitation, USA

Paul Shekelle, PhD (Internist), Cochrane Back Group

Jeffrey L Susman, MD (Family Practice), American Academy of Family Physicians, USA

Ottawa Methods Group:

Lucie Brosseau, PhD (Public Health, specialization in epidemiology), Career Scientist, Ministry of Ontario Health (Canada), and Assistant Professor, Physiotherapy Program, School of Rehabilitation Sciences, University of Ottawa, Ottawa, Ontario, Canada

Peter Tugwell, MD, MSc (Epidemiology), Chair, Centre for Global Health, Institute of Population Health

George A Wells, PhD (Epidemiology and Biostatistics), Professor and Chairman, Department of Epidemiology and Community Medicine, University of Ottawa, Ottawa, Ontario, Canada

Vivian A Robinson, MSc (Kinesiology), Research Associate, Clinical Epidemiology Unit, Ottawa Health Research Institute, Ottawa Civic Hospital, Ottawa, Ontario, Canada

Ian D Graham, PhD (Medical Sociology), Medical Research Council Scholar, Clinical Epidemiology Unit, Ottawa Health Research Institute, Ottawa Hospital, Civic Campus, Ottawa, Ontario, Canada

Beverley J Shea, MSc (Epidemiology), Research Associate, Department of Medicine, University of Ottawa, and Clinical Epidemiology Unit, Ottawa Health Research Institute, Ottawa Hospital, Civic Campus, Ottawa, Ontario, Ontario, Canada

Jessie McGowan, Director of the Medical Library, Ottawa Hospital, Ottawa, Ontario, Canada

Joan Peterson, Research Associate, Department of Medicine, Clinical Epidemiology Unit, Ottawa Health Research Institute, Ottawa Hospital, Civic Campus, Ottawa, Ontario, Canada

Michel Tousignant. PhD, Lucie Poulin, MSc, He1ene Corriveau, PhD, Michelle Morin, BSc, Lucie Pelland, PhD, Lucie Laferriere, MHA, Lynn Casimiro, Louis E Tremblay, Program of Physiotherapy, School of Rehabilitation Sciences, Faculty of Health Sciences, University of Ottawa, Ottawa, Ontario, Canada

* Oxford, England: The Cochrane Collaboration, 2000.

[dagger] Dettori JR, Bullock SH, Sutlive TG, et al. The effects of spinal flexion and extension exercises and their associated postures in patients with acute low back pain. Spine. 1995;20:2303-2312.

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Address all correspondence and requests for reprints to: Peter Tugwell, MD, MSc, Chair, Centre for Global Health, Institute of Population Health, 1 Stewart St, Rm 312, Ottawa, Ontario, Canada K1N 6N5 ([e-mail]).

This study was financially supported by an unrestricted educational grant from the Cigna Foundation, Philadelphia, Pa, USA, the Ministry of Human Resources and Development, Government of Canada (Summer Students Program), and the Ontario Ministry of Health and Long-Term Care (Canada). Ian Graham is a Medical Research Council Scholar, Canadian Institutes of Health Research (Canada).