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

INTRODUCTION

Shoulder pain is among the most common reasons for visits to a general practitioner. The prevalence of shoulder pain accompanied by disability is approximately 20% in the general population. (1) Prospective studies in Europe have shown that approximately 11 out of 1,000 patients seen by a family practitioner have shoulder pain. Over 50% of patients diagnosed by a general practitioner to have shoulder tendinitis are referred for physical therapy. (2)

Numerous rehabilitation interventions are available for the management of shoulder pain, including thermotherapy, therapeutic ultrasound, transcutaneous electrical nerve stimulation (TENS), and therapeutic exercises. Among general practitioners, there is a wide variety of treatment approaches, likely related to uncertainty about the efficacy of these multiple interventions. (3) Furthermore, the interpretation of shoulder pain research is complicated by the broad inclusion criteria that allow mixed populations with different etiologies of shoulder pain.

Two systematic reviews of randomized controlled trials (RCTs) of physical treatments for shoulder pain reported no evidence of benefit for shoulder pain. (4,5) Evidence-based treatment guidelines for certain interventions have been published in the British Medical Journal (BMJ) clinical series for nonspecific shoulder pain. (6)

The purpose of this article is to describe the evidence-based clinical practice guidelines (EBCPGs) developed by the Philadelphia Panel regarding rehabilitation interventions for shoulder pain. The aim of developing the EBCPGs was to improve appropriate use of rehabilitation interventions for shoulder 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 "Philadelphia Panel 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 RCTs, nonrandomized controlled clinical trials (CCTs), or case control or cohort studies that evaluated the interventions of interest in a population with shoulder pain. Shoulder pain was defined as nonspecific shoulder pain, calcific tendinitis, bursitis, and capsulitis. Rheumatoid arthritis and osteoporotic shoulder pain were excluded from these guidelines because the underlying cause of pain is different. The outcomes of interest were chosen by consensus by the panel and included functional status, pain, ability to work, patient global assessment, patient satisfaction, and quality of life. The interventions assessed were massage, thermotherapy (hot or cold packs), electrical stimulation, TENS, therapeutic ultrasound, therapeutic exercises, and combinations of these rehabilitation interventions. Iontophoresis was excluded because it includes a mix of medication and ultrasound, and medication is not a physical rehabilitation intervention. Acceptable control groups received either a placebo therapy or no therapy. 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 (7) and modifications proposed by Haynes et al. (8) 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 on a 5-point validated scale that assigns 2 points each for randomization and double-blinding and 1 point for description of withdrawals. (9,10) 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.

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 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 a 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 in 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 rifled "Philadelphia Panel Evidence-Based Clinical Practice Guidelines on Selected Rehabilitation Interventions: Overview and Methodology"). A master grid showing each rehabilitation intervention assessed and the strength and level of evidence is shown in Table 2. For those interventions for which 1 or more eligible studies were found, the results follow the same order as this grid (from left to right, top to bottom).

Clinically important benefit was shown for therapeutic ultrasound for calcific tendinitis (Tab. 3). There is no evidence of clinically important benefit for therapeutic ultrasound for other types of shoulder pain (capsulitis, bursitis, tendinitis) (Tab. 4).

Therapeutic exercises, TENS, thermotherapy, and massage have limited evidence available, but the trials available were insufficient to draw conclusions (11-16) (Tab. 5). The Philadelphia Panel EBCPGs are compared with other published guidelines in Appendix 1.

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.

RESULTS

Literature Search

The electronic literature search and hand-searching identified 2,496 citations that pertained to shoulder pain. Of these, 54 were retrieved for closer examination after screening the titles and abstracts. Of these, only 23 met the inclusion criteria, and 12 citations that met the inclusion criteria were excluded due to irrelevant outcomes or lack of appropriate control group (Fig. 1).

[FIGURE 1 OMITTED]

CALCIFIC SHOULDER TENDINITIS

Eligible studies were identified only for therapeutic ultrasound.

Therapeutic Ultrasound for Calcific Shoulder Tendinitis, Level I (RCT), Grade A for Pain and Function (Clinically Important Benefit)

Summary of Trials: One RCT (N=61) was included of therapeutic ultrasound versus a placebo for calcific tendinitis of the shoulder. (17) One CCT was excluded because no outcomes of interest were reported (18) (only range of motion [ROM] and size of calcified deposit were reported). One RCT (N=22) was excluded because acetic acid iontophoresis was combined with therapeutic ultrasound. (19)

Efficacy: Clinically important benefit demonstrated. There was a clinically important and statistically significant reduction in pain (77% relative to the control group) and improvement in functional status (15% relative to the control group) after 2 months of therapy (Tab. 6, Fig. 2). There was also a decrease in calcification of 37% relative to placebo (17) (Tab. 7) (P < .05). There were no differences between groups at 9 months posttherapy. (17)

[FIGURE 2 OMITTED]

Strength of Published Evidence in Comparison With Other Guidelines: The Philadelphia Panel found good evidence (level I, RCT) of benefit with therapeutic ultrasound at 2 months, but no difference after the end of 9 months of therapy.

Clinical Recommendation in Comparison With Other Guidelines: The Philadelphia Panel recommends there is good evidence to include continuous therapeutic ultrasound (5 times per week) as an intervention for short-term pain relief of calcific shoulder tendinitis (level I, grade A for pain and function) for a 2-month period.

Practitioner Agreement

* Response rate for this EBCPG: 49%

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

* Agree with recommendation: 76%

* Think a majority of my colleagues would agree: 61%

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

Practitioner Comments

1. No difference at 9 months, so why recommend?

2. Frequency of treatment was very high in study by Ebenlicher et al (17) (5 times per week for 3 weeks).

3. Exercise is very helpful for these patients. Why was it not evaluated?

Panel's Response: The EBCPG clearly specifies the lack of effect at 9 months, so that clinicians can decide whether a short-term benefit is desirable. The frequency of treatment is now specified in the EBCPG. No trials of exercise for shoulder tendinitis met the inclusion criteria for the EBCPG development process, as described in Table 5.

NONSPECIFIC SHOULDER PAIN

Therapeutic Ultrasound for Nonspecific Shoulder Pain (Capsulitis, Bursitis, Tendinitis), Level I (RCT), Grade C for Pain, Patient Global Assessment, and Function (No Evidence of Benefit)

Summary of Trials: Four RCTs (20-23) and 3 CCTs (24-26) were identified that compared therapeutic ultrasound with a placebo. Three trials were excluded due to lack of a placebo (or untreated) control group. (14,16,27) One retrospective study of therapeutic ultrasound versus no intervention was excluded. (28)

Efficacy: None demonstrated. Two RCTs (N=40) compared continuous therapeutic ultrasound with a placebo. (20,21) Meta-analysis of pain and function showed no evidence of benefit at 2, 4, or 8 weeks. Two RCTs (N=253) compared pulsed therapeutic ultrasound with a palcebo and found no difference in pain or function. (22,23) The results from 2 CCTs (N=50) also failed to show a significant or minimal clincally important benefit of therapeutic ultrasound on pain, patient global assessment, or function as measured by activities of daily living (ADL). (24-26) The pooled results for pain and ADL are shown in Figure 3. One CCT (n=20) demonstrated a 37% relative difference in pain between therapeutic ultrasound (81%, 9 out of 11 patients) and placebo (44%, 4 out of 9 patients) 3 weeks posttherapy, but this difference was not staistically significant. (25)

[FIGURE 3 OMITTED]

Strength of Published Evidence in Comparison With Other Guidelines: The Philadelphia Panel found good scientific evidence (level I, RCTs), which showed no evidence of benefit.

Clinical Recommendation in Comparison With Other Guidelines: The Philadelphia Panel recommends there is poor evidence to include or exclude either continuous or pulsed therapeutic ultrasound alone (grade C for pain, patient global assessment, and function) as an intervention for nonspecific shoulder pain (due to capsulitis, bursitis, or tendinitis).

Interventions With Insufficient Evidence

For therapeutic exercises, 2 CCTs were identified of therapeutic exercises versus a control for shoulder pain, but these trials were excluded due to nonvalidated outcomes (11) and poorly defined diagnoses. (12) One RCT (N=80) compared a group that received exercise with a control group that received detuned laser. (29) There was better functional status (as indicated by the Neer shoulder score) and less pain in the exercise group at both 3 and 6 months; however, no variance was available, so the data could not be analyzed. (29) Several trials without control groups were excluded that compared different types of exercise. (30-33)

For thermotherapy, one CCT of ice versus a control was excluded because no outcomes of interest were measured (ROM only). (34)

For TENS, one comparative RCT versus therapeutic ultrasound was excluded. (16)

Therapeutic massage was used as a cointervention in a physical therapy group, but the effects of the individual massage component of the program could not be determined. (15)

Electromyographic (EMG) biofeedback was superior to traditional exercises for anterior shoulder instability in one RCT. (32) However, because there was no control group, it is impossible to draw conclusions about the efficacy of EMG biofeedback.

Electrical stimulation was not used in any of the studies identified.

DISCUSSION

A thorough literature search, data synthesis using meta-analysis, quality assessment, and consensus panel assessment have reviewed the evidence for 7 rehabilitation interventions for shoulder pain. Only 1 intervention (therapeutic ultrasound for calcified shoulder tendinitis) was shown to have a clinically important benefit.

As with other systematic reviews and guideline development projects, there are methodologic limitations. These limitations are discussed in the accompanying methodology article (see article titled "Philadelphia Panel Evidence-Based Clinical Practice Guidelines on Selected Rehabilitation Interventions: Overview and Methodology" in this issue).

The effectiveness of rehabilitation interventions for the management of shoulder pain is a complex issue. Rehabilitation specialists use concomitant treatment interventions in daily practice. (15,35) The therapeutic application of several concurrent rehabilitation interventions are based on empirical experience, (35-37) and the measurement of their effects is complex. (38) The practice of rehabilitation requires a better theoretical basis (39,40) and well-designed controlled trials. (41)

The Philadelphia Panel EBCPGs for the management of shoulder pain are largely in agreement with previous and recent EBCPGs (6) for shoulder joint pain exhibited in Appendix 1. The Philadelphia Panel EBCPGs for shoulder joint pain have the advantage that they were developed based on a systematic grading of the evidence determined by an expert panel, and the evidence was derived from systematic reviews and metaanalyses using the Cochrane Collaboration methodology. The finalized EBCPGs 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 the management of shoulder joint pain in their daily practice.

There are very few published guidelines for the management of shoulder pain. Managed care guidelines have been developed based on observations and expert opinion. (42) Preferred conservative treatment programs are described by the American Physical Therapy Association. (43) However, these guidelines are vague concerning which interventions should be used and are not based on a scientific review of the evidence.

There are several rehabilitation interventions that were not assessed by this panel, such as the use of intraarticular corticosteroid injections. There is evidence from meta-analysis and clinical trials that these interventions may offer clinically important benefit on shoulder function and pain relief. (44,45) The practitioner managing a patient needs to consider other interventions that have not been assessed by this EBCPG development project.

Therapeutic Ultrasound

Therapeutic ultrasound showed clinically important benefit for calcified shoulder tendinitis. (17) However, ultrasound was not shown to provide clinically important benefit for nonspecific shoulder pain such as capsulitis, bursitis, or tendinitis. Phonophoresis was not considered in our systematic review. The Philadelphia Panel recommendation regarding nonspecific shoulder pain (level I, grade C) agrees with the BMJ guidelines, which also concluded that evidence for the effectiveness of ultrasound is lacking. It is suggested that therapeutic ultrasound is one of the rehabilitation interventions that is selectively effective, depending on the condition treated or the characteristics of therapeutic application. (46,47)

The RCTs were of good quality (4 out of 5 on the Jadad scale (9,10)) (Appendix 2). The highest methodological quality was found in the more recent RCTs. (17,23) The type of therapeutic ultrasound was continuous in all trials, except for one trial (23) in which a pulsed therapeutic ultrasound type was used for a chronic shoulder condition. It is clinically recommended to use a continuous mode in chronic conditions. (48) There was a wide variety of diagnostic groups, therapeutic applications, and follow-up durations. Calibration of the therapeutic ultrasound device was not described in most studies. These results concur partially with previous systematic reviews (5,35,49) of nonspecific shoulder pain or soft tissue shoulder disorders. These 3 systematic reviews did not include the most recent trial on calcified shoulder tendinitis (17) in their analyses. Further investigations should be conducted on the optimal therapeutic application of therapeutic ultrasound in relation to the type of conditions managed. (35,48)

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

Despite the fact there is a positive physiological effect of these interventions, (46,50-55) there are no clinical data or insufficient clinical information on the effectiveness of therapeutic exercises, EMG biofeedback, TENS, thermotherapy, therapeutic massage, electrical stimulation, and combined rehabilitation interventions for shoulder joint pain. These results concur with recent systematic reviews on physical rehabilitation interventions for painful shoulders. (4,5,44) These researchers included comparative trials as well as placebo-controlled trials. Conclusions of head-to-head comparison could lead to results that 2 rehabilitation interventions are equally effective or equally ineffective. (44) Firm conclusions of efficacy require comparison with a standard treatment. Is there a standard treatment in physical rehabilitation? Obviously, there is an urgent need to conduct well-designed studies on the effectiveness of these interventions for shoulder pain.

Special attention on the characteristics of the therapeutic application (39) is needed in the field of rehabilitation. For example, the types of exercises used, adequate exercise intensity, and progression need to be clarified according to patient-specific classification of physical dysfunction, needs, treatment goals, and outcomes. (56,57) The effectiveness of massage could be influenced by the types of maneuvers used, the massage approach adopted, years of experience of the therapist, number and size of the muscles involved, the patient's position used, pressure exerted, rhythm and progression, and frequency and duration of the treatment sessions. (52) The characteristics of a specific clinical device and the selection of treatment variables are of key importance. (50,51,53,58-60)

The Philadelphia Panel was unable to make clinical recommendations regarding these interventions for shoulder pain. This is in agreement with the BMJ (6) for all of these rehabilitation interventions except for TENS. The BMJ (6) found good evidence regarding the effectiveness of TENS for the management of shoulder pain as opposed to the Philadelphia Panel, but this finding was based on the use of TENS during distension arthrography. This surgical intervention was excluded from the Philadelphia Panel review. For therapeutic exercises, the BMJ (6) reported no evidence for exercises compared with manual therapy for shoulder pain. No recommendation, however, was made for therapeutic exercises alone.

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.

There is an urgent need for RCTs to determine whether commonly applied rehabilitation interventions for shoulder pain are effective at reducing pain and improving long-term patient-important outcomes. This research should pay attention to the dosing schedule, in terms of device characteristics for electrical modalities and duration and frequency of sessions for physical treatments. Furthermore, the adherence to recommended therapy should be considered in the analysis.

CONCLUSION

There is evidence to support and recommend the use of therapeutic ultrasound for calcified shoulder tendinitis. There is a lack of evidence at present regarding whether to include or exclude the use of therapeutic exercises, thermotherapy, therapeutic massage, EMG biofeedback, TENS, electrical stimulation, and combined rehabilitation interventions for nonspecific shoulder pain 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
Shoulder Pain (a)

Rehabilitation
Intervention                           Philadelphia Panel (2001)

Therapeutic        Strength of         Fair scientific evidence (level
  exercises          published            II) for therapeutic
                     evidence            exercises  for nonspecific
                                         shoulder pain
                   Clinical            No evidence to include or
                     recommendations     exclude therapeutic exercises
                                         alone for shoulder pain

Therapeutic        Strength of         Good scientific evidence (level
  ultrasound         published           I) for therapeutic
                     evidence            ultrasound
                   Clinical            Good evidence to include or
                     recommendations     exclude (grade A for pain and
                                         function) therapeutic
                                         ultrasound alone as an
                                         intervention for calcified
                                         shoulder
                                       Poor evidence to include or
                                         exclude (grade C for pain,
                                         patient global assessment,
                                         and function) therapeutic
                                         ultrasound alone as an
                                         intervention for nonspecific
                                         shoulder pain

TENS               Strength of         Insufficient evidence
                     published
                     evidence
                   Clinical            Insufficient evidence to
                     recommendations     include or exclude TENS alone
                                         as an intervention for
                                         shoulder pain (ID)

EMG                Strength of         None found
  biofeedback        published
                     evidence
                   Clinical            No data found
                     recommendations

Therapeutic        Strength of         Insufficient scientific
  massage            published           evidence (level ID) for
                     evidence            therapeutic massage
                   Clinical            Insufficient evidence to
                     recommendations     include or exclude (grade
                                         ID) therapeutic massage alone
                                         as an intervention for
                                         shoulder pain

Thermotherapy      Strength of         Insufficient scientific
                     published           evidence (level ID) for
                     evidence            cyrotherapy
                   Clinical            Insufficient evidence to
                     recommendations     include or exclude (grade ID)
                                         cryotherapy alone as an
                                         intervention for shoulder
                                         pain

Electrical         Strength of         N/A
  stimulation        published
                     evidence
                   Clinical            No data found
                     recommendations

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

Rehabilitation
Intervention                           BMJ (6) (2000)

Therapeutic        Strength of         N/R
  exercises          published
                     evidence
                   Clinical            No evidence that therapeutic
                     recommendations     exercises combined with
                                         manual therapy is effective
                                         for shoulder pain

Therapeutic        Strength of         N/R
  ultrasound         published
                     evidence
                   Clinical            Insufficient evidence of an
                     recommendations     effect of therapeutic
                                         ultrasound for shoulder pain

TENS               Strength of         N/R
                     published
                     evidence
                   Clinical            Good evidence on the effects of
                     recommendations     TENS on shoulder pain during
                                         distension arthrography

EMG                Strength of         N/R
  biofeedback        published
                     evidence
                   Clinical            N/C
                     recommendations

Therapeutic        Strength of         N/R
  massage            published
                     evidence
                   Clinical            N/C
                     recommendations

Thermotherapy      Strength of         N/R
                     published
                     evidence
                   Clinical            Insufficient evidence on the
                     recommendations     effects of cryotherapy for
                                         shoulder pain

Electrical         Strength of         N/C
  stimulation        published
                     evidence
                   Clinical            N/C
                     recommendations

Combined           Strength of         N/R
  rehabilitation     published
  interventions      evidence
                   Clinical            N/C
                     recommendations

(a) N/A=not applicable, N/C=not considered, N/R=not reported,
ID=insufficient data, TENS=transcutaneous electrical nerve
stimulation, EMG=electromyographic, BMJ=British Medical Journal.
Appendix 2.

Characteristics of Included Trials (a)

Author/Year          Sample Size      Population Details

Berry et al, (20)    24               Rotator cuff lesion
  1980

Brox et al, (29)     Placebo (n=30)   Shoulder pain >3 mo.
  1993               Exercise (n=50)    resistant to physical
                                        therapy

Downing and          20               Shoulder pain during
  Weinstein, (21)                       at least one activity
                                        and at the end
                                        range of at least
                                        one ROM test

Ebenbichler et       61               Radiographically
  al, (17) 1999                         verified calcific
                                        tendinitis (type 1 or
                                        type 2)

Mueller et al, (24)  14               Periarthritis
  1954

Munting, (25) 1978   29               Shoulder pain,
                                        limitation of active
                                        and passive ROM

Nykanen, (22)        73               Painful shoulder
  1995

Roman, (26) 1960     36               Bursitic shoulder
                                        conditions

van der Heijden      180              Pain in deltoid region,
  et al, (23) 1999                      aggravated by
                                        movement

                                                      Age (Mean,
                                      Symptom         SD for
Author/Year          Sample Size      Duration        Control)

Berry et al, (20)    24               Subacute to     56.2 y
  1980                                  chronic         (11.2 y)

Brox et al, (29)     Placebo (n=30)   >3 mo           48 y
  1993               Exercise (n=50)

Downing and          20               >1 mo and <1 y  52 y
  Weinstein, (21)

Ebenbichler et       61               >4 wk           54 (10) y
  al, (17) 1999

Mueller et al, (24)  14               7 wk to 6 y     36-74 y
  1954

Munting, (25) 1978   29               Mean=6.2-9.2    59.3 y
                                        mo

Nykanen, (22)        73               >2 mo           67 (9) y
  1995

Roman, (26) 1960     36               Not reported    Not reported

van der Heijden      180              17 mo           51 (14) y
  et al, (23) 1999

Author/Year          Sample Size      Treatment

Berry et al, (20)    24               Therapeutic ultrasound
  1980

Brox et al, (29)     Placebo (n=30)   Supervised exercises 2 X/wk
  1993               Exercise (n=50)    + home exercises (relaxed
                                        repetitive movements)

Downing and          20               Therapeutic ultrasound
  Weinstein, (21)                       1.2 W/[cm.sup.2] followed by
                                        active-assisted and passive
                                        ROM

Ebenbichler et       61               Therapeutic ultrasound
  al, (17) 1999                         2.2 W/[cm.sup.2]

Mueller et al, (24)  14               Therapeutic ultrasound
  1954                                  2 W/[cm.sup.2], 5 min
                                        frequency=[10.sup.6] cycles
                                        per second

Munting, (25) 1978   29               Therapeutic ultrasound
                                        0.5 W/[cm.sup.2]

Nykanen, (22)        73               Therapeutic ultrasound
  1995                                  1 W/[cm.sup.2]

Roman, (26) 1960     36               Therapeutic ultrasound

van der Heijden      180              Pulsed therapeutic ultrasound
  et al, (23) 1999

Author/Year          Sample Size      Comparison Group

Berry et al, (20)    24               Placebo therapeutic
  1980                                  ultrasound

Brox et al, (29)     Placebo (n=30)   Detuned laser
  1993               Exercise (n=50)

Downing and          20               Placebo therapeutic
  Weinstein, (21)                       ultrasound followed by
                                        active-assisted and
                                        passive ROM exercises

Ebenbichler et       61               Placebo therapeutic
  al, (17) 1999                         ultrasound

Mueller et al, (24)  14               Placebo therapeutic
  1954                                  ultrasound

Munting, (25) 1978   29               Untreated

Nykanen, (22)        73               Placebo
  1995

Roman, (26) 1960     36               Placebo therapeutic
                                        ultrasound

van der Heijden      180              Placebo therapeutic
  et al, (23) 1999                      ultrasound

                                      Concurrent
Author/Year          Sample Size      Therapy

Berry et al, (20)    24               Paracetamol as
  1980                                  required

Brox et al, (29)     Placebo (n=30)   None
  1993               Exercise (n=50)

Downing and          20               Home exercises,
  Weinstein, (21)                       NSAIDS

Ebenbichler et       61               Occasional analgesics
  al, (17) 1999                         ultrasound

Mueller et al, (24)  14               None, asked to forego
  1954                                  other treatments

Munting, (25) 1978   29               Home and supervised
                                        exercise

Nykanen, (22)        73               Massage, group
  1995                                  gymnastics
                                        (stretching and
                                        strengthening),
                                        analgesics and anti-
                                        inflammatories
                                        allowed

Roman, (26) 1960     36               Moist heat,
                                        mobilization
                                        exercises

van der Heijden      180              Exercise therapy,
  et al, (23) 1999                      supervised and at
                                        home

                                      Sessions/
                                      Week, No.
Author/Year          Sample Size      of Weeks

Berry et al, (20)    24               2 X/wk 4 wk
  1980

Brox et al, (29)     Placebo (n=30)   2 X/wk
  1993               Exercise (n=50)    12, 24 wk

Downing and          20               3 X/wk
  Weinstein, (21)                       4 wk

Ebenbichler et       61               5 for 3 wk,
  al, (17) 1999                         then 3 for 3
                                        wk

Mueller et al, (24)  14               5X/wk
  1954                                  2 wk

Munting, (25) 1978   29               Week 1; 5X;
                                        week 2:
                                        3X; week
                                        3: 2X

Nykanen, (22)        73               3 X/wk
  1995                                  4 wk

Roman, (26) 1960     36               Alternating
                                        days, 10
                                        treatments

van der Heijden      180              2 X/wk
  et al, (23) 1999                      6 wk

                                      Follow-     Quality (9,10)
Author/Year          Sample Size      up          (R, B, W)

Berry et al, (20)    24               None        1, 0, 0
  1980

Brox et al, (29)     Placebo (n=30)   None        1, 0, 1
  1993               Exercise (n=50)

Downing and          20               None        2, 2, 0
  Weinstein, (21)

Ebenbichler et       61               None        2, 2, 1
  al, (17) 1999

Mueller et al, (24)  14               2 wk        0, 2, 0
  1954

Munting, (25) 1978   29               12 wk       0, 0, 1

Nykanen, (22)        73               1 y         1, 2, 1
  1995

Roman, (26) 1960     36               Not         0, 0, 0
                                        reported

van der Heijden      180              1 y         2, 2, 1
  et al, (23) 1999

(a) R=randomization, B=blinding, W=withdrawals, ROM=range of motion,
NSAID=nosteroidal anti-inflammatory drug.
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 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 Shoulder Pain Guidelines (a)

                                                  Capsulitis, Bursitis
                          Calcific                Tendinitis,
                          Tendinitis              Nonspecific Pain

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

(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
randomized controlled trials.
Table 3.

Grade A Guideline: Clinically Important Benefit Demonstrated (a)

                                                  Relative    Study
Guideline         Recommendation  Outcomes        Difference  Design

Therapeutic       Grade A         Pain, 8 wk      77%         1 RCT
  ultrasound for  Grade A         Function, 8 wk  15%         (N=61)
  calcific        Grade A         Quality of      25%
  shoulder                          life, 8 wk
  tendinitis

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

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

Guideline                                            Recommendation

Therapeutic ultrasound for nonspecific shoulder      Grade C
pain (capsulitis, bursitis, tendinitis)              Grade C
                                                     Grade C

Guideline                                            Outcomes

Therapeutic ultrasound for nonspecific shoulder      Pain
pain (capsulitis, bursitis, tendinitis)              Function
                                                     Patient global
                                                       assessment

                                                     Relative
Guideline                                            Difference

Therapeutic ultrasound for nonspecific shoulder      No benefit
pain (capsulitis, bursitis, tendinitis)                demonstrated

Guideline                                            Study Design

Therapeutic ultrasound for nonspecific shoulder      3 RCTs, 3 CCTs
pain (capsulitis, bursitis, tendinitis)              (N=376)

(a) RCT=randomized controlled trial, CCT=nonrandomized controlled
clinical trial.
Table 5.

Rehabilitation Interventions With Insufficient Data (a)

Intervention and
Indication                    Details

Therapeutic exercises for     Two trials with poorly defined
  nonspecific shoulder          diagnosis (Ginn et al (11) defined
  pain                          nonspecific shoulder pain as
                                "unilateral shoulder pain," and
                                Pearlmutter et al (12) looked at
                                nonspecific shoulder pain and
                                nonvalidated outcomes [pain and
                                function scale] in women with
                                osteoporosis)

Thermotherapy for             1 CCT (N=20) with no relevant
  nonspecific shoulder          outcomes (range of motion only) (13)
  pain                          and 1 head-to-head CCT of ice
                                versus therapeutic ultrasound
                                (N=31) (14)

Massage for nonspecific       Head-to-head RCT (N=24) of massage,
  shoulder pain                 strengthening, and stretching versus
                                a different exercise program (15)

TENS for nonspecific          Head-to-head RCT (N=29) of
  shoulder pain                 therapeutic ultrasound versus
                                TENS (16)

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

Pain, Function, and Quality of Life After 2 Months of Therapeutic
Ultrasound for Calcific Shoulder Tendinitis (a)

                                                      No. of
Study          Treatment Group      Outcome           Patients

Ebenbichler    E: therapeutic       Pain, 0-15,       32
  et al (17)     ultrasound           15 better
                 2.2 W/[cm.sup.2]
               C: placebo                             29

Ebenbichler    E: therapeutic       Function: ADL     32
  et al (17)     ultrasound           index, 0-20,
                 2.2 W/[cm.sup.2]     20 better
               C: placebo                             29

Ebenbichler    E: therapeutic       Quality of        32
  et al (17)     ultrasound           life, 0-10
                 2.2 W/[cm.sup.2]     cm VAS
               C: placebo                             29

                                                      Baseline
Study          Treatment Group      Outcome           Mean

Ebenbichler    E: therapeutic       Pain, 0-15,        5.6
  et al (17)     ultrasound           15 better
                 2.2 W/[cm.sup.2]
               C: placebo                              6.9

Ebenbichler    E: therapeutic       Function: ADL     15.0
  et al (17)     ultrasound           index,  0-20,
                 2.2 W/[cm.sup.2]     20 better
               C: placebo                             14.6

Ebenbichler    E: therapeutic       Quality of         6.1
  et al (17)     ultrasound           life, 0-10
                 2.2 W/[cm.sup.2]     cm VAS
               C: placebo                              6.6

                                                      End-of-
                                                      Study
Study          Treatment Group      Outcome           Mean

Ebenbichler    E: therapeutic       Pain, 0-15,       12
  et al (17)     ultrasound           15 better
                 2.2 W/[cm.sup.2]
               C: placebo                              8.5

Ebenbichler    E: therapeutic       Function: ADL     18.6
  et al (17)     ultrasound           index,  0-20,
                 2.2 W/[cm.sup.2]     20 better
               C: placebo                             16

Ebenbichler    E: therapeutic       Quality of         8.1
  et al (17)     ultrasound           life, 0-10
                 2.2 W/[cm.sup.2]     cm VAS           7
               C: placebo                              8.1

                                                      Absolute
Study          Treatment Group      Outcome           Benefit

Ebenbichler    E: therapeutic       Pain, 0-15,       4.80 (I) on
  et al (17)     ultrasound           15 better         15-point
                 2.2 W/[cm.sup.2]                       Likert scale
               C: placebo

Ebenbichler    E: therapeutic       Function: ADL     2.20 (I) on
  et al (17)     ultrasound           index,  0-20,     20-point
                 2.2 W/[cm.sup.2]     20 better         scale
               C: placebo

Ebenbichler    E: therapeutic       Quality of        1.60 (I) on
  et al (17)     ultrasound           life, 0-10        10-cm VAS
                 2.2 W/[cm.sup.2]     cm VAS
               C: placebo

                                                      Relative
                                                      Difference
                                                      in Change
                                                      From
Study          Treatment Group      Outcome           Baseline

Ebenbichler    E: therapeutic       Pain, 0-15,       77%(I)
  et al (17)     ultrasound           15 better
                 2.2 W/[cm.sup.2]
               C: placebo

Ebenbichler    E: therapeutic       Function: ADL     15%(I)
  et al (17)     ultrasound           index,  0-20,
                 2.2 W/[cm.sup.2]     20 better
               C: placebo

Ebenbichler    E: therapeutic       Quality of        25%(I)
  et al (17)     ultrasound           life, 0-10
                 2.2 W/[cm.sup.2]     cm VAS
               C: placebo

(a) E=exercise group, C=control group, ADL=activities of daily
living, VAS=visual analog scale.
Table 7.

Calcification 9 Months After Therapeutic Ultrasound for Calcific
Shoulder Tendinitis (a)

                                                      No.
Study          Treatment Group      Outcome           Improved

Ebenbichler    E: therapeutic       Decreased         15
  et al (17)     ultrasound           calcification
                 2.2 W/[cm.sup.2]
               C: placebo                              3

                                                      No. of
Study          Treatment Group      Outcome           Patients

Ebenbichler    E: therapeutic       Decreased         32
  et al (17)     ultrasound           calcification
                 2.2 W/[cm.sup.2]
               C: placebo                             29

                                                      Risk (% of
Study          Treatment Group      Outcome           Occurrence)

Ebenbichler    E: therapeutic       Decreased         47%
  et al (17)     ultrasound           calcification
                 2.2 W/[cm.sup.2]
               C: placebo                             10%

                                                      Risk
Study          Treatment Group      Outcome           Difference

Ebenbichler    E: therapeutic       Decreased         37%
  et al (17)     ultrasound           calcification
                 2.2 W/[cm.sup.2]
               C: placebo

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

Acknowledgments: Summer students: Sarah Milne, Michael Saginur, Marie-Josee Noel, Malanie 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 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. Academy of Family Physicians, USA

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, 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

Helene Corriveau, PhD, Michelle Morin, BSc, Lucie Pelland, PhD, Lucie Poulin, MSc, Michel Tousignant, PhD, Lucie Laferriare, 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 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).