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Special Issue |
Clinical Specialty Experts
(Orthopaedic Surgeon), American Academy of Orthopaedic Surgeons, USA
(Internist, Rheumatologist), American College of Physicians, USA
(Physiatrist)
(Internist), University of Pennsylvania, Philadelphia. USA
(Neurologist), American Academy of Neurology, USA
(Physical Therapist), American Physical Therapy Association, USA
(Physical Therapist), American College of Rheumatology, Association of Health Professionals, USA
(Physiatrist), American Academy of Physical Medicine and Rehabilitation, USA
(Internist), Cochrane Back Group. Academy of Family Physicians, USA
(Family Practice), American Academy of Family Physicians, USA
Ottawa Methods Group
(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
(Epidemiology), Chair, Centre for Global Health, Institute of Population Health
(Epidemiology and Biostatistics), Professor and Chairman, Department of Epidemiology and Community Medicine, University of Ottawa, Ottawa, Ontario, Canada
(Kinesiology), Research Associate, Clinical Epidemiology Unit, Ottawa Health Research Institute, Ottawa Civic Hospital, Ottawa, Ontario, Canada
(Medical Sociology), Medical Research Council Scholar, Clinical Epidemiology Unit, Ottawa Health Research Institute, Ottawa Hospital, Civic Campus, Ottawa, Ontario, Canada
(Epidemiology), Research Associate, Department of Medicine, University of Ottawa and Clinical Epidemiology Unit, Ottawa Health Research Institute, Ottawa Hospital, Civic Campus, Ottawa, Ontario, Canada
Director of the Medical Library, Ottawa Hospital, Ottawa, Ontario, Canada
Research Associate, Department of Medicine, Clinical Epidemiology Unit, Ottawa Health Research Institute, Ottawa Hospital, Civic Campus, Ottawa, Ontario, Canada
Program of Physiotherapy, School of Rehabilitation Sciences, Faculty of Health Sciences, University of Ottawa, Ottawa, Ontario, Canada
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 (ptugwell{at}uottawa.ca)
| Abstract |
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Key Words: Clinical practice guidelines Evidence-based practice Meta-analysis Physical therapy Rehabilitation Shoulder pain
| INTRODUCTION |
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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 |
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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 Collaboration7 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 posttherapy: 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 titled "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).
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| RESULTS |
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| CALCIFIC SHOULDER TENDINITIS |
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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 reported18 (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 placebo17 (Tab. 7) (P<.05). There were no differences between groups at 9 months posttherapy.17
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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
Practitioner Comments
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 |
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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).2426 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
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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 outcomes11 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.3033
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 |
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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,3537 and the measurement of their effects is complex.38 The practice of rehabilitation requires a better theoretical basis39,40 and well-designed controlled trials.41
The Philadelphia Panel EBCPGs for the management of shoulder pain are largely in agreement with previous and recent EBCPGs6 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 meta-analyses 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 intra-articular 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 scale9,10) (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 trial23 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 reviews5,35,49 of nonspecific shoulder pain or soft tissue shoulder disorders. These 3 systematic reviews did not include the most recent trial on calcified shoulder tendinitis17 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,46,5055 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 application39 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.50,51,53,5860
The Philadelphia Panel was unable to make clinical recommendations regarding these interventions for shoulder pain. This is in agreement with the BMJ6 for all of these rehabilitation interventions except for TENS. The BMJ6 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 BMJ6 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 |
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| Appendix 1. |
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| Appendix 2. |
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| Footnotes |
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Acknowledgments: Summer students: Sarah Milne, Michael Saginur, Marie-Josée Noël, Mélanie Brophy, Anne Mailhot
* Oxford, England: The Cochrane Collaboration, 2000. ![]()
| References |
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