Philadelphia panel evidence-based clinical practice guidelines on selected rehabilitation interventions for neck pain. (Specail Issue).

INTRODUCTION

Neck pain is the second largest cause of time off work, after low back pain (LBP). (1,2) Acute neck pain is usually the result of injury or accident, most often road vehicle accidents associated with whiplash. Some prognostic studies have suggested that chronic neck pain is related to repetitive working conditions. However, there is also an association between depression and chronic neck pain and LBP.

The most commonly prescribed intervention for the management of neck pain by general practitioners is rest, followed by analgesics. (3,4) Neck pain is one of the most common conditions for referral to a physical therapist. Despite the prevalence of neck pain, there is a lack of evidence for commonly used rehabilitation interventions. (5) The most recent guidelines for the management of neck pain are the Quebec Task Force on Spinal Disorders (QTF) (6) and the British Medical Journal (BMJ) (7) guidelines. These guidelines are both in the process of being updated.

The purpose of this article is to describe the Philadelphia Panel evidence-based clinical practice guidelines (EBCPGs) of rehabilitation interventions for nonspecific neck pain. The aim of the developing the EBCPGs was to improve appropriate use of rehabilitation interventions for neck 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 paper in this issue (see article titled "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 of more than 10 patients with nonspecific neck pain. Nonspecific neck pain was defined as pain in the neck area, with or without radiation to the extremities. 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, electromyographic (EMG) biofeedback, transcutaneous electrical nerve stimulation (TENS), therapeutic ultrasound, therapeutic exercises, and combinations of these rehabilitation interventions. Control groups that received active treatments were included. Concurrent interventions were allowed if they were given in the same way to both the experimental and control groups (eg, home exercises, educational booklets, advice on posture). However, concurrent interventions that were given to one group but not the other group were not accepted (eg, education by means of lectures for the control group was 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 (8) and modifications proposed by Haynes et al. (9) 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 with a 5-point validated scale that assigns 2 points each for randomization and double-blinding and 1 point for description of withdrawals. (10,11) Differences in data extraction and quality assessment were resolved by consensus.

STATISTICAL ANALYSIS

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 thought to be dependent on disease duration, the analysis was conducted for 2 categories of neck pain: acute (< 4 weeks duration) and chronic (> 12 weeks duration). If the population contained patients with mixed acute and chronic disease duration, the study was excluded.

Where possible, data from individual trials were combined using meta-analysis with the Review Manager (RevMan) computer program, Version 4.1 for Windows. * Continuous data were analyzed using weighted mean differences, where the difference between the treatment and control groups from each study included in the meta-analysis is weighted by the inverse of the variance and the outcome is reported in the original units (eg, centimeters). Where the same conceptual outcome was measured with different scales (eg, pain, functional status), the data were analyzed with standardized mean differences (SMDs). The SMD is calculated as the mean difference between treatment and control groups divided by standard deviation, and weighted by the inverse of the variance. Dichotomous data were analyzed using relative risk. The confidence that the different trials measured the same treatment effect (homogeneity of effect) was tested using a chi-square statistic. When homogeneity 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 (> 15%) and statistical significance were shown in one or more RCTs. Grade B recommendations were assigned for interventions with a clinically important benefit (> 15%) that is statistically significant 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 on a 5-point scale (2 points for randomization, 2 points for blinding, I point for description of withdrawals). 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) for those interventions for which eligible studies were found.

Clinically important benefit was shown only for therapeutic exercises for chronic neck pain (Tab. 3). There was no evidence of clinically important benefit for 3 other interventions (Tab. 4). Insufficient data were available for 4 interventions (Tab. 5). No trials were identified for ice, heat, or EMG biofeedback. The Philadelphia Panel EBCPGs are compared with other published guidelines in Appendix 1.

RESULTS AND RECOMMENDATIONS

Literature Search

The literature search identified 3,476 articles. Of these, 203 were retrieved for closer screening. Of these, 8 trials met all selection criteria. The distribution of these trials by intervention is shown in Figure 1.

[FIGURE 1 OMITTED]

A survey questionnaire was sent to 324 practitioners for feedback on the 9 grade A or B recommendations. Their comments were reviewed by the Philadelphia Panel and were incorporated in this EBCPG document. 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 inappropriate samples (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 NECK PAIN (< 4 WEEKS)

Mechanical Traction for Acute Neck Pain (< 4 Weeks), Level II (CCT), Grade ID (Insufficient Data)

Summary of Trials: One nonrandomized controlled trial (N=135) of patients following an acute neck injury was excluded due to the poor quality of the trial (quality=1 out of 5). (12) One RCT of continuous traction was excluded because the patient population included a mix of patients with acute and chronic neck pain, which could not be separated. (13)

Efficacy: No reliable data.

Strength of Published Evidence in Comparison With Other Guidelines: The Philadelphia Panel found no evidence for traction for acute neck pain. This is in agreement with the QTF, (6) which found no scientific evidence for traction for acute neck pain.

Recommendation: The Philadelphia Panel recommended that there is insufficient evidence to include or exclude (ID) mechanical traction alone as an intervention for acute nonspecific neck pain.

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

Summary of Trials: One RCT (N=20) of TENS (15 minutes, 3 per week at 0.2 milliseconds, 80 Hz) versus neck collar for patients with acute neck pain (< 3 days) and no neurological signs was included. (14)

Efficacy: None demonstrated. There was no difference in patient-assessed pain after 1 week or 3 months between a neck collar and TENS (14) (Fig. 2).

[FIGURE 2 OMITTED]

Strength of Published Evidence in Comparison With Other Guidelines: The Philadelphia Panel found good scientific evidence (level I, RcT) that TENS did not show evidence of effect on pain. In contrast, the QTF (6) found no evidence for TENS in acute neck pain.

Clinical Recommendation in Comparison 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 neck pain.

Interventions for Acute Neck Pain With Insufficient Evidence

No evidence from controlled trials or cohort studies was found for EMG biofeedback, thermotherapy, massage, electrical stimulation, therapeutic exercises, or combined interventions for acute neck pain.

For therapeutic exercises, one RCT of manual therapy combined with exercises was excluded because manual therapy was not given to the control group. (15) Another RCT, which compared continuing normal activities with neck collar and time off work, was excluded because of lack of an appropriate control group (ie, the effects of neck collar and sick leave could not be separated). (16)

For combined interventions, one RCT of combined rehabilitation interventions was excluded because manual therapy was given to the treatment group but not to the control group?

CHRONIC NECK PAIN (> 12 WEEKS)

Therapeutic Exercises for Chronic Neck Pain (> 12 Weeks),

Level I (RCT), Grade A for Pain and Function, Grade B for Patient Global Assessment (Clinically Important Benefit)

Summary of Trials: Three RCTs (N=223) were included. (18-20) One CCT (N=73) was included. (21) Three comparative RCTs were excluded due to lack of an appropriate control group. (22-24) One RCT was excluded because the treatment was a multifactor, behavioral intervention. (25)

Efficacy: One CCT (N=47) found significant and clinically important patient global assessment with isometric exercises with a risk difference of 41% relative to an untreated control group (21) (Tab. 6, Fig. 3). For group fitness classes, 2 RCTs (N=195) showed no difference between group classes and control for pain or sick leave at 1 or 6 months (19,20) (Fig. 4). Individual sessions of therapeutic exercises that included proprioceptive re-education (consisting of slow neck movements to follow a moving target) relieved pain and improved functional status, by 36% and 33%, respectively, relative to a waiting list control in one RCT (N=60) (18) (Tab. 7, Fig. 5).

[FIGURES 3-5 OMITTED]

Strength of Published Evidence in Comparison With Other Guidelines: The Philadelphia Panel found good scientific evidence (level I), which showed clinically important benefit on pain and function with supervised, isometric or slow neck movement exercises. No data were available on return to work with individualized exercises.

Clinical Recommendation in Comparison With Other Guidelines: The Philadelphia Panel recommends that there is good evidence to include supervised exercise programs alone (including proprioceptive and traditional exercises) for the management of chronic (> 12 weeks) neck pain (grade A for pain and function, grade B for patient global assessment).

Practitioner Agreement

* Response rate for this EBCPG: 47%

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

* Agree with recommendation: 93%

* Think a majority of my colleagues would agree: 86%

* Will (or already) follow this recommendation: 96%

Practitioner Comments

1. Negative trials are not described in Table 3. (19,20)

2. Not all options for chronic neck pain have been evaluated by this panel.

3. Pastural exercises should be evaluated/described.

4. I believe stretching is more important.

Panel's Response: The 2 negative trials used group aerobic fitness programs and are shown in Figure 4. The Philadelphia Panel evaluated selected interventions, as described in the "Methods" section. This may not have been clear in the practitioner feedback survey. No trials of pastural exercises were found. Stretching was a component of the effective programs and has now been included in the guideline statement.

Mechanical Traction for Chronic Neck Pain (> 12 Weeks), Level II (CCT), Insufficient Data (ID)

Summary of Trials: One CCT (N=73) of patients with cervical pain radiating to the extremities was excluded (21) due to low quality (quality=0 out of 5). One RCT was excluded because the population included a mix of both patients with acute and chronic neck pain. (26) One RCT of patients with cervical radiculopathy was excluded because no acceptable outcomes were measured (only EMG activity). (27) One RCT of continuous traction was excluded because the patient population included a mix of patients with acute and chronic neck pain, which could not be separated. (13)

Efficacy: Insufficient data. The excluded CCT demonstrated an improvement relative to the control (untreated group) in patient-assessed improvement with intermittent mechanical traction. However, due to the low quality of the trial, the validity of this effect is uncertain.

Strength of Published Evidence in Comparison With Other Guidelines: The Philadelphia Panel found insufficient data for mechanical traction similar to the QTF, (6) which found no scientific evidence.

Clinical Recommendation in Comparison With Other Guidelines: There are insufficient data to make a recommendation regarding mechanical traction alone in chronic neck pain.

Therapeutic Ultrasound for Chronic Neck Pain (> 12 Weeks), Level II, Grade C for Pain (No Evidence of Benefit)

Summary of Trials: One RCT (N=26) of patients with myofascial trigger point neck pain was included. (28)

Efficacy: None demonstrated. There was no difference in pain between therapeutic ultrasound and placebo therapeutic ultrasound. Other outcomes were not assessed (Fig. 6).

[FIGURE 6 OMITTED]

Strength of Published Evidence in Comparison with Other Guidelines: The Philadelphia Panel found good scientific evidence (level I) that showed no benefit of therapeutic ultrasound on pain relief for chronic neck pain. The QTF (6) found no scientific evidence.

Clinical Recommendation in Comparison 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 neck pain.

Interventions for Chronic Neck Pain With Insufficient Data

Interventions that could not be assessed due to lack of controlled studies were EMG biofeedback, massage, thermotherapy, electrical stimulation, TENS, and combined rehabilitation interventions.

For combined interventions, one RCT was excluded because manual therapy was included in the "physiotherapy" group, but not the control group. (29)

DISCUSSION

Evidence-based practice is rapidly growing in the rehabilitation domain. (30) The Philadelphia Panel concluded that therapeutic strengthening and proprioceptive exercises are the only rehabilitation interventions examined for cervical pain that have been shown in one or more controlled trials to provide a clinically important benefit. As with all such reviews, there are a number of limitations.

As for LBP, the effectiveness of conservative treatment of cervical syndrome is a complex issue. (5,31-34) Rehabilitation specialists often use concomitant treatment interventions within the same treatment session for a particular patient with a cervical syndrome. Certain rehabilitation interventions such as cryotherapy, ultrasound application, and massage are used for pain relief in the acute stage or as a treatment preparation before the main intervention. (35) These treatment approaches are chosen based on empirical experience. (35,36) The use of single and specific interventions does not reflect the complexity of the global approach adopted by rehabilitation specialists in clinical settings. The practice of rehabilitation requires a better theoretical basis (37,38) supported by well-designed controlled research. (39)

The measurement of treatment effects is complex. (40,41) Standardized measurement of outcomes is needed to facilitate scientific advances in clinical care for cervical syndromes. Little is known about valid and sensitive outcome measures in the spine. (42) The Philadelphia Panel agreed that the primary outcomes of clinical importance are: pain, functional status, patient global assessment, quality of life, return to work, and patient satisfaction.

The effectiveness of physical rehabilitation interventions for cervical syndrome is affected by psychosocial, physical, and occupational factors. (1,43-54) Management recommendations suggest that these factors should be considered in the clinical evaluation of patients with cervical pain. (48) These factors could not be addressed in this review.

Several methodological biases may be present in the clinical trials of cervical pain. The lack of precise diagnoses contributes to a misclassification bias. (4,46,55-60) For example, the terminology used to describe cervical syndrome was vague and included terms such as "tension neck," "frequent neck symptoms," and "cervical pain." A wide variety of clinical characteristics such as age, prevalent versus incident cases, stages of the disease, level of pain, and presence or absence of neurological deficits may have resulted in selection bias. Differences in disease duration were minimized in these guidelines by excluding studies with a mix of patients with acute and chronic conditions or mixed diagnoses. Characteristics of the device parameters and of the therapeutic application (37) could also affect the treatment effect observed. The tendency for trials with nonsignificant results to not be published may result in an overestimate of the treatment effect due to publication bias. (61) We could not assess the presence of publication bias due to the small number of trials. A language bias was introduced because the Philadelphia Panel reviewed only studies published in English, French, or Spanish.

The quality of studies on cervical syndrome rarely reached 2 out of 5 or greater on the Jadad scale (Appendix 2). Randomization (3/6 studies) was rarely fully adequate (ie, performed using computerized random number lists). Insufficient information about the treatment assignment procedure was noted in several RCTs. Inappropriate blinding (5/6 studies) could lead to an overestimate of the treatment effect. Complete blinding is difficult to achieve because of visual and other sensory differences between treatment and placebo as well as unintended communication between patient and evaluator. (62) Few investigators (1/6 studies) reported adequate information regarding withdrawals and loss to follow-up or indicated whether they were considered in the data analysis. These weaknesses contribute to the lower quality assessment scores in many of the systematic reviews conducted on rehabilitation interventions for cervical syndrome.

Ottenbacher (63) lists several difficulties for rehabilitation specialists: (1) discriminate between clinical and statistical significance, (2) low statistical power in detecting minimal clinical important differences, and (3) lack of replication of rehabilitation studies to strengthen evidence-based practice. Some studies (3/6 studies) did not use adequate sample sizes to detect important differences with confidence (Appendix 2). These issues contribute to nonconclusive results for several interventions. The Philadelphia Panel agreed that clinical importance be defined as an improvement of 15% or more relative to a control (see article titled "Evidence-Based Clinical Practice Guidelines on Selected Rehabilitation Interventions: Overview and Methodology"). Grade A or B recommendations were required to demonstrate both clinical importance and statistical significance.

The Philadelphia Panel EBCPGs for the management of cervical pain are mainly in agreement with previous and recent EBCPGs (7) for neck pain described in Appendix 1. The Philadelphia Panel EBCPGs for cervical pain have the advantage that they were developed based on a systematic grading of the evidence determined by an expert, transdisciplinary panel and the evidence was derived from systematic reviews and meta-analyses using the Cochrane Collaboration methodology. (64) The finalized guidelines were circulated for feedback from practitioners to verify their applicability and ease of use for practicing clinicians. This rigorous methodological procedure provides considerable credibility for rehabilitation specialists who intend to use these EBCPGs for cervical management in their daily practice.

Therapeutic Exercises

Our meta-analysis showed that proprioceptive and traditional therapeutic exercises are effective for pain relief in chronic cervical pain. No included studies considered exercises for acute or subacute conditions. In contrast to our results, 3 recent reviews concluded that there was insufficent evidence regarding therapeutic exercises for neck pain. (5,32,33) Functional exercises including proprioceptive phasic exercises have been described as effective in another review. (65) Types of exercise, intensity, and progression need to be clarified according to patient specific classification of physical dysfunction, needs, treatment goals, and outcomes. (4,66,67)

Mechanical Traction

Although 3 RCTs have been conducted in acute (12) and chronic (21) cervical pain, the results did not meet the criteria for a consistent clinically important benefit for intermittent traction. Static traction was not used by investigators in the included studies.

These results are mainly in concordance with previous systematic reviews for acute and chronic cervical pain management,(5,32,42) even though these authors did not clearly distinguish between manual and mechanical traction. Our systematic review included patients with cervical pain with neurological signs in I of the 2 trials. (21) Pennie et all (2) did not report whether their subjects with cervical soft tissue injuries exhibited neurological signs. According to the information provided by these trials, none of the included subjects had disk involvement. Furthermore, exclusion criteria, such as acute strain, sprains, presence of inflammation, or joint instability of the spine, were not consistently reported in the primary trials. The proposed clinical indication for static or sustained traction is the presence of a nuclear disk protrusion. (68,69) Thus, the use of intermittent traction by Goldie et al (21) is questionable. (70) This point shows the importance of identifying homogenous subgroups of patients with neck pain based on precise differential physical dysfunction diagnostic classes, such as nerve root adhesion, hypomobility dysfunction, and sacroiliac hypermobility. (71) The effectiveness of intermittent mechanical traction was not demonstrated by the existing studies, mainly due to the inclusion of patients with neurological signs, which required more likely a mechanical traction in static mode. Other confounding variables such as neck position, traction force, duration of traction, angle of pull, and position of the patient need to be further investigated. (72)

Therapeutic Ultrasound

Our systematic review found no evidence of clinically important benefit of therapeutic ultrasound for chronic cervical syndrome.(28) No studies were found on therapeutic ultrasound for acute neck conditions. Other research work is obviously needed for cervical syndrome at different stages of the condition. The Philadelphia Panel recommendation (level II, grade C) disagrees with the QTF quidelines, (6) which recommended therapeutic ultrasound for muscle spasm and pain relief, though no scientific evidence was described. The BMJ (7) guidelines did not evaluate therapeutic ultrasound.

The single trial available was of medium quality (3 out of 5 on the Jadad scale(10,11)). The type of therapeutic ultrasound was continuous in this study. (28) It is usually recommended for chronic pain, (73) but does not seem to be effective. Other confounding variables such as randomization method, characteristics of the device, size of the head, and study duration (1 week) may have contributed to the lack of treatment effect of therapeutic ultrasound in this trial. (35,37) These results concur with a previous systematic review, (35) even though it was conducted for various musculoskeletal conditions.

TENS

The Philadelphia Panel recommended that there was poor evidence to include or exclude TENS for acute neck pain, based on the lack of measured effect in one RCT. (14) These results agree with other systematic reviews of cervical pain. (5,32) The Philadelphia Panel EBCPGs (level I, grade C) are in agreement with QTF guidelines, (6) which do not recommend TENS for cervical pain. However, the QTF guidelines6 do not differentiate between electroanalgesia and TENS. The BMJ guidelines (7) did not evaluate TENS for pain relief. Specific therapeutic application of TENS is of key importance. Vibratory stimulation has been recommended as part of the TENS application. (74-76) Nordemar et al (14) did not mention the use of vibratory stimulation' in their study. There is a need for strict and rigorous RCTs of TENS using combined vibratory stimulation. Identification of the appropriate target clientele may be also an important factor. (77)

EMG Biofeedback, Therapeutic Massage, Thermotherapy, Electrical Stimulation, and Combined Rehabilitation Interventions

There are many studies in the scientific literature showing the positive physiological effects of these interventions. (78-82) Despite the physiological effects, either there are no clinical data or there is insufficient clinical information on the effectiveness of EMG biofeedback, therapeutic massage, thermotherapy, electrical stimulation, and combined rehabilitation interventions for acute and chronic cervical syndrome. (83-85)

The Philadelphia Panel was unable to make a clinical recommendation regarding these specific interventions. This is in agreement with BMJ (7) and QTF (6) guidelines, which did not evaluate these interventions.

Overall

The main difficulty in determining the effectiveness of rehabilitation interventions is the lack of well-designed prospective RCTs. An enormous research effort should be done in conducting RCTs for almost each rehabilitation interventions for acute or chronic cervical syndrome. This situation is critical compared with the neck pain research area. Future research in physical therapy should also 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 scientific evidence to support and recommend the use of proprioceptive and therapeutic exercises for chronic neck pain. There is a lack of evidence at present regarding whether to include or exclude the use of thermotherapy, therapeutic massage, EMG biofeedback, mechanical traction, therapeutic ultrasound, TENS, electrical stimulation, and combined rehabilitation interventions in the daily practice of physical rehabilitation of patients with acute and chronic neck pain.

Appendix 1.

Strength of Published Evidence and Clinical Recommendations of
Previous Evidence-Based Clinical Practice Guidelines (EBCPGs) for
Acute and Chronic Neck Pain (a)

Rehabilitation
Intervention       Evidence-Based CPGs    Philadelphia Panel (2001)

Previous EBCPGs for Acute Neck Pain (< 4 Weeks)

Therapeutic        Quality of published   N/A
  exercises          evidence

                   Clinical               No data found
                     recommendations

Mechanical         Quality of published   Fair scientific evidence
  traction           evidence               (level I) for mechanical
                                            traction

                   Clinical               Insufficient evidence to
                     recommendations        include or exclude
                                            (grade ID) mechanical
                                            traction alone as an
                                            intervention for acute
                                            nonspecific neck pain

Therapeutic        Quality of published   N/A
  ultrasound         evidence

                   Clinical               No data found
                     recommendations

TENS               Quality of published   Good scientific evidence
                     evidence               (level I) for TENS

                   Clinical               Poor evidence to include
                     recommendations        or exclude (grade C for
                                            pain) TENS alone as an
                                            intervention for acute
                                            LBP

EMG biofeedback    Quality of published   N/A
                     evidence

                   Clinical               No data found
                     recommendations

Therapeutic        Quality of published   N/A
  massage            evidence

                   Clinical               No data found
                     recommendations

Thermotherapy      Quality of published   N/A
                     evidence

                   Clinical               No data found
                     recommendations

Electrical         Quality of published   N/A
  stimulation        evidence

                   Clinical               No data found
                     recommendations

Combined           Quality of published   N/A
  rehabilitation     evidence
  interventions
                   Clinical               No data found
                     recommendations

Previous EBCPGs for Chronic Neck Pain (> 12 Weeks)

Therapeutic        Quality of published   Good scientific
  exercises          evidence               evidence (level I) for
                                            therapeutic exercises

                   Clinical               Good evidence (grade A for
                     recommendations        pain and function, grade
                                            B for patient global
                                            assessment) to include
                                            supervised therapeutic
                                            exercises

Mechanical         Quality of published   Insufficient evidence
  traction           evidence

                   Clinical               Insufficient data to make a
                     recommendations        recommendation

Therapeutic        Quality of published   Fair scientific evidence
  ultrasound         evidence               (level II) for therapeutic
                                            ultrasound

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

TENS               Quality of published   N/A
                     evidence

                   Clinical               No data found
                     recommendations

EMG biofeedback    Strength of published  N/A
                     evidence

                   Clinical               No data found
                     recommendations

Therapeutic        Strength of published  N/A
  massage            evidence

                   Clinical               No data found
                     recommendations

Thermotherapy      Strength of published  N/A
                     evidence

                   Clinical               No data found
                     recommendations

Electrical         Strength of published  N/A
  stimulation        evidence

                   Clinical               No data found
                     recommendations

Combined           Strength of published  N/A
  rehabilitation     evidence
  interventions

                   Clinical               No data found
                     recommendations

Rehabilitation
Intervention       Evidence-Based CPGs    Qu&bec Task Force (6) (1987)

Previous EBCPGs for Acute Neck Pain (< 4 Weeks)

Therapeutic        Quality of published   Common practice, but no
  exercises          evidence               scientific evidence

                   Clinical               Listed as option to increase
                     recommendations        strength, ROM, and
                                            endurance

Mechanical         Quality of published   Not in common practice, but
  traction           evidence               no scientific evidence

                   Clinical               Listed as option to increase
                     recommendations        ROM

Therapeutic        Quality of published   Common practice, but no
  ultrasound         evidence               scientific evidence

                   Clinical               Ultrasound is grouped with
                     recommendations        thermotherapy and listed
                                            as an option to diminish
                                            muscle spasm and relieve
                                            symptomatic pain

TENS               Quality of published   Not in common practice, but
                     evidence               no scientific evidence

                   Clinical               Electroanalgesia is listed
                     recommendations        as an option for
                                            symptomatic pain relief

EMG biofeedback    Quality of published   Common practice, but no
                     evidence               scientific evidence

                   Clinical               EMG biofeedback is listed as
                     recommendations        an option to diminish
                                            muscle spasm

Therapeutic        Quality of published   Common practice, but no
  massage            evidence               scientific evidence

                   Clinical               Therapeutic massage is
                     recommendations        listed as an option to
                                            diminish muscle spasm

Thermotherapy      Quality of published   Common practice, but no
                     evidence               scientific evidence

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

Electrical         Quality of published   N/C
  stimulation        evidence

                   Clinical               N/C
                     recommendations

Combined           Quality of published   N/C
  rehabilitation     evidence
  interventions
                   Clinical               Recommended that physical
                     recommendations        therapists 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 Chronic Neck Pain (> 12 Weeks)

Therapeutic        Quality of published   Common practice, but no
  exercises          evidence               scientific evidence

                   Clinical               Listed as option to increase
                     recommendations        strength, ROM, and
                                            endurance

Mechanical         Quality of published   Common practice, but no
  traction           evidence               scientific evidence

                   Clinical               Listed as option to increase
                     recommendations        ROM

Therapeutic        Quality of published   Common practice, but no
  ultrasound         evidence               scientific evidence

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

TENS               Quality of published   Usefulness demonstrated by
                     evidence               nonrandomized controlled
                                            trial

                   Clinical               Electroanalgesia is listed as
                     recommendations        an option for symptomatic
                                            pain relief

EMG biofeedback    Strength of published  Common practice, but no
                     evidence               scientific evidence

                   Clinical               EMG biofeedback is listed as
                     recommendations        an option to diminish
                                            muscle spasm

Therapeutic        Strength of published  Common practice, but no
  massage            evidence               scientific evidence

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

Thermotherapy      Strength of published  Common practice, but no
                     evidence               scientific evidence

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

Electrical         Strength of published  N/C
  stimulation        evidence

                   Clinical               N/C
                     recommendations

Combined           Strength of published  N/C
  rehabilitation     evidence
  interventions

                   Clinical               Recommended that physical
                     recommendations        therapists 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

Rehabilitation
Intervention       Evidence-Based CPGs    BMJ (7) (2000)

Previous EBCPGs for Acute Neck Pain (< 4 Weeks)

Therapeutic        Quality of published   N/A
  exercises          evidence

                   Clinical               Good evidence that early
                     recommendations        mobilization physical
                                            therapy and return to
                                            normal activity were more
                                            effective than rest or
                                            immobilization for acute
                                            whiplash

Mechanical         Quality of published   N/R
  traction           evidence

                   Clinical               Insufficient evidence on the
                     recommendations        effects of traction in
                                            people with uncomplicated
                                            neck pain without
                                            neurological deficit

Therapeutic        Quality of published   N/C
  ultrasound         evidence

                   Clinical               N/C
                     recommendations

TENS               Quality of published   N/C
                     evidence

                   Clinical               N/C
                     recommendations

EMG biofeedback    Quality of published   N/R
                     evidence

                   Clinical               Insufficient evidence on the
                     recommendations        effects of biofeedback in
                                            uncomplicated neck pain
                                            without severe neurological
                                            deficit

Therapeutic        Quality of published   N/C
  massage            evidence

                   Clinical               N/C
                     recommendations

Thermotherapy      Quality of published   N/R
                     evidence

                   Clinical               Insufficient evidence on the
                     recommendations        effects of heat or cold in
                                            uncomplicated neck pain
                                            without severe neurological
                                            deficit

Electrical         Quality of published   N/C
  stimulation        evidence

                   Clinical               N/C
                     recommendations

Combined           Quality of published   N/R
  rehabilitation     evidence
  interventions
                   Clinical               Insufficient evidence of the
                     recommendations        effects of physical
                                            treatments in uncomplicated
                                            neck pain without severe
                                            neurological deficit

Previous EBCPGs for Chronic Neck Pain (> 12 Weeks)

Therapeutic        Quality of published   N/R
  exercises          evidence

                   Clinical               Insufficient evidence of the
                     recommendations        effects of exercises in
                                            people with uncomplicated
                                            neck pain without
                                            neurological deficit

Mechanical         Quality of published   N/R
  traction           evidence

                   Clinical               Insufficient evidence of the
                     recommendations        effects of traction in
                                            people with uncomplicated
                                            neck pain without
                                            neurological deficit

Therapeutic        Quality of published   N/C
  ultrasound         evidence

                   Clinical               N/C
                     recommendations

TENS               Quality of published   N/C
                     evidence

                   Clinical               N/C
                     recommendations

EMG biofeedback    Strength of published  N/R
                     evidence

                   Clinical               Insufficient evidence on the
                     recommendations        effects of biofeedback in
                                            people with uncomplicated
                                            neck pain without
                                            neurological deficit

Therapeutic        Strength of published  N/C
  massage            evidence

                   Clinical               N/C
                     recommendations

Thermotherapy      Strength of published  N/R
                     evidence

                   Clinical               Insufficient evidence of the
                     recommendations        effects of heat or ice in
                                            people with uncomplicated
                                            neck pain without
                                            neurological deficit

Electrical         Strength of published  N/C
  stimulation        evidence

                   Clinical               N/C
                     recommendations

Combined           Strength of published  N/R
  rehabilitation     evidence
  interventions

                   Clinical               Insufficient evidence of the
                     recommendations        effects of physical
                                            treatments in people with
                                            uncomplicated neck pain
                                            without neurological
                                            deficit

(a) N/A = not applicable, N/R = not reported, N/C = not considered,
ROM = range of motion.
Appendix 2.

Characteristics of Included Trials. (a)

                    Sample                       Symptom
Author/Year         Size     Population          Duration

Goldie and             73    Cervical pain       Chronic
  Landquist, (21)              radiating           (mean=5 y)
  1970                         down upper
                               extremities

Klemetti et           170    Tension neck        Chronic
  al, (19) 1997

Lee et al, (28)        26    Myofascial          Chronic
  1997                         trigger point

Nordemar and           20    No neurological     Acute <3 d
  Thomer, (14)                 symptoms in
  1981                         extremities

Pennie and            135    Neck soft-tissue    Acute
  Agambar, (12)                injuries from
  1990                         accident

Revel et al, (18)      30    >3 mo,              Chronic
  1994                         rheumatology
                               outpatients

Takala et al, (20)     23    "Frequent neck      Chronic
  1994                         symptoms"

                              Age (y)
                    Sample   (Mean, SD,
Author/Year         Size     Controls)      Treatment

Goldie and             73    Not reported   1. Isometric exercise
  Landquist, (21)                           2. Intermittent traction
  1970                                        (25-40 lb)

Klemetti et           170    42 y           Physical treatment +
  al, (19) 1997                               exercise

Lee et al, (28)        26    43.7 (14.3)    1. Therapeutic
  1997                                        ultrasound 0.5
                                              W/[cm.sup.2]
                                            2. Electrotherapy
                                            3. Therapeutic
                                              ultrasound +
                                              electrotherapy

Nordemar and           20    34 (25-43)     TENS
  Thomer, (14)
  1981

Pennie and            135    Not reported   Traction (intermittent)
  Agambar, (12)
  1990

Revel et al, (18)      30    47 (25-74)     Proprioceptive
  1994                                        exercises based on
                                              eye-head coupling

Takala et al, (20)     23    43 (38-49)     Exercise
  1994

                    Sample   Comparison      Concurrent
Author/Year         Size     Group           Therapy

Goldie and             73    Untreated       Advice,
  Landquist, (21)                              paracetamol
  1970

Klemetti et           170    Untreated       None
  al, (19) 1997

Lee et al, (28)        26    Placebo         None
  1997                         ultrasound

Nordemar and           20    Neck collar     Analgesics
  Thomer, (14)                (control)
  1981

Pennie and            135    Neck collar     Advice +
Agambar, (12)                                  home active
  1990                                         exercises

Revel et al, (18)      30    Waiting list    None
  1994                         control

Takala et al, (20)     23    Untreated       None, but
  1994                                         crossover
                                               trial

                    Sample   Sessions/   Treatment
Author/Year         Size     Week        Duration    Follow-up

Goldie and             73    3           3 wk        6 mo
  Landquist, (21)
  1970

Klemetti et           170    2           4 wk        6 mo
  al, (19) 1997

Lee et al, (28)        26    1           1 session   None
  1997

Nordemar and           20    3           2 wk        3 mo
  Thomer, (14)
  1981

Pennie and            135    2           8 wk        None
  Agambar, (12)
  1990

Revel et al, (18)      30    2           8 wk        10 wk
  1994

Takala et al, (20)     23    N/A         2 mo        5 mo
  1994

                    Sample   Quality (10,11)
Author/Year         Size     (R, B, W)

Goldie and             73     0, 0, 0
  Landquist, (21)
  1970

Klemetti et           170     0, 0, 0
  al, (19) 1997

Lee et al, (28)        26     1, 2, 0
  1997

Nordemar and           20     1, 0, 1
  Thomer, (14)
  1981

Pennie and            135     0, 1, 0
  Agambar, (12)
  1990

Revel et al, (18)      30     1, 0, 0
  1994

Takala et al, (20)     23     1, 0, 0
  1994

(a) R=randomization, B=blinding, W=withdrawals, N/A=not available.
Table 1.

Details of Philadelphia Panel Classification System

          Clinical              Statistical
          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 Interventional for Neck Pain (a)

                                       Acute         Chronic

Exercise/neuromuscular re-education    nd            [check] A, I
Traction                               [check] C, I  [check] C, II
Therapeutic ultrasound                 nd            [check] C, I
TENS                                   [check] C, I  ID
Massage                                nd            ID
Thermotherapy                          nd            nd
Electrical stimulation                 ID            ID
EMG biofeedback                        nd            nd
Combined rehabilitation interventions  nd            ID

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

Grade A Guidelines: Clinically Important Benefit Demonstrated (a)

Guideline                Recommendation  Outcomes

Individual, supervised,  Grade B         Patient global assessment
  therapeutic exercises  Grade A         Function
  for chronic            Grade A         Pain
  nonspecific neck       No data         Return to work
  pain

                         Relative
Guideline                Difference      Study Design

Individual, supervised,  33%-41%         1 CCT (N=47)
  therapeutic exercises  49%             1 RCT (N=60)
  for chronic            36%
  nonspecific neck       No data
  pain

(a) CCT=controlled clinical trial, RCT=randomized controlled trial.
Table 4.

Grade C Rehabilitation Interventions: No Clinically Important Benefit
Demonstrated (a)

Guideline                Recommendation  Outcomes

TENS for acute neck      Grade C         Pain
  pain
Therapeutic ultrasound   Grade C         Pain
  for chronic neck pain

                         Relative
Guideline                Difference      Study Design

TENS for acute neck      No effect       1 RCT (N=20)
  pain
Therapeutic ultrasound   No effect       1 RCT (N=26)
  for chronic neck pain

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

Rehabilitation Interventions With Insufficient Data (a)

Intervention and         Details
indication

Mechanical traction for  One CCT (N=135) was excluded due to poor
  acute neck pain          quality (quality=1 out of 5). No other data
                           available.
Mechanical traction for  One CCT (N=73, quality=8) was excluded
  chronic nonspecific      due to low quality. (21) No other trials
  neck pain                were available.
TENS for chronic neck    Effect on pain measured immediately after 1
  pain                     treatment session; no ongoing therapy
                           schedule or follow-up. Panel agreed the
                           therapy was not relevant to practice (too
                           short).
Electrical stimulation   Effect on pain measured immediately after 1
  for chronic neck pain    treatment session; no ongoing therapy
                           schedule or follow-up. Panel agreed the
                           therapy was not relevant to practice (too
                           short).
Combined rehabilitation  Types of intervention poorly defined and not
  interventions for        comparable to each other.
  chronic neck pain
Massage for chronic      Head-to-head trial. No evidence versus
  neck pain                placebo available.

(a) CCT=controlled clinical trial, TENS=transcutaneous electrical
nerve stimulation.
Table 6.

Patient Global Assessment at 1 Month Post-exercise Therapy for Chronic
Neck Pain (a)

                                                          No.
Study              Treatment Group        Outcome         Improved

Goldie and         E: isometric exercise  Patient global  17
  Landquist, (21)                           improvement
  1970             C: untreated control                    7

                                                          No. of
Study              Treatment Group        Outcome         Patients

Goldie and         E: isometric exercise  Patient global  24
  Landquist, (21)                           improvement
  1970             C: untreated control                   23

                                                          Risk (% of
Study              Treatment Group        Outcome         Occurrence)

Goldie and         E: isometric exercise  Patient global  71%
  Landquist, (21)                           improvement
  1970             C: untreated control                   30%

                                                          Risk
Study              Treatment Group        Outcome         Difference

Goldie and         E: isometric exercise  Patient global  41%
  Landquist, (21)                           improvement
  1970             C: untreated control

(a) E=exercise group, C=control group.
Table 7.

Pain at 1 Month After Exercises for Chronic Neck Pain (a)

                   Treatment                            No. of
Study              Group              Outcome           Patients

Revel et al, (18)  E: proprioceptive  Pain, VAS 100 mm  30
  1994               re-education
                   C: control                           30

                   Treatment                            Baseline
Study              Group              Outcome           Mean

Revel et al, (18)  E: proprioceptive  Pain, VAS 100 mm  50.5
  1994               re-education
                   C: control                           45.9

                   Treatment                            End-of-Study
Study              Group              Outcome           Mean

Revel et al, (18)  E: proprioceptive  Pain, VAS 100 mm  28.7
  1994               re-education
                   C: control                           41.6

                   Treatment                            Absolute
Study              Group              Outcome           Benefit

Revel et al, (18)  E: proprioceptive  Pain, VAS 100 mm  -17.50 (I) on
  1994               re-education                       100-mm VAS
                   C: control

                                                        Relative
                                                        Difference in
                   Treatment                            Change From
Study              Group              Outcome           Baseline

Revel et al, (18)  E: proprioceptive  Pain, VAS 100 mm  36% (I)
  1994               re-education
                   C: control

E=exercise group, C=control group, VAS=visual analog scale.

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, Pa, 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, MD, 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,, Ottawa, Ontario, Canada

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 Hospital, Civic Campus, 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, 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

Lucie Poulin, MSc, Michel Tousignant, PhD, Helene Corriveau, PhD, Michelle Morin, BSc, Lucie Pelland, PhD, Lucie Laferriere, MHA, Lynn

Casimiro, Louis E Tremblay, PhD, Program of Physiotherapy, School of Rehabilitation Sciences, Faculty of Health Sciences, University of Ottawa, Ottawa, Ontario, Canada

* Oxford, England: The Cochrane Collaboration, 2000.

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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 KIN 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).