Author Names
Bennell, K., Wee, E., Coburn, S., Green, S., Harris, A., Staples, M., Forbes, A., Buchbinder, R.
Reviewer Name
Ericka Boeger, SPT
Reviewer Affiliation(s)
Duke University School of Medicine, Doctor of Physical Therapy Division
Paper Abstract
Objective: To investigate the efficacy of a programme of manual therapy and exercise treatment compared with placebo treatment delivered by physiotherapists for people with chronic rotator cuff disease.
Design: Randomised, participant and single assessor blinded, placebo-controlled trial.
Setting: Metropolitan region of Melbourne, Victoria, Australia.
Participants: 120 participants with chronic (>3 months) rotator cuff disease recruited through medical practitioners and from the community.
Interventions: The active treatment comprised a manual therapy and home exercise programme; the placebo treatment comprised inactive ultrasound therapy and application of an inert gel. Participants in both groups received 10 sessions of individual standardised treatment over 10 weeks. For the following 12 weeks, the active group continued the home exercise programme and the placebo group received no treatment.
Main outcome measures: The primary outcomes were pain and function measured by the shoulder pain and disability index, average pain on movement measured on an 11 point numerical rating scale, and participants’ perceived global rating of overall change.
Results: 112 (93%) participants completed the 22 week trial. At 11 weeks no difference was found between groups for change in shoulder pain and disability index (3.6, 95% confidence interval -2.1 to 9.4) or change in pain (0.7, -0.1 to 1.5); both groups showed significant improvements. More participants in the active group reported a successful outcome (defined as “much better”), although the difference was not statistically significant: 42% (24/57) of active participants and 30% (18/61) of placebo participants (relative risk 1.43, 0.87 to 2.34). The active group showed a significantly greater improvement in shoulder pain and disability index than did the placebo group at 22 weeks (between group difference 7.1, 0.3 to 13.9), although no significant difference existed between groups for change in pain (0.9, -0.03 to 1.7) or for the percentage of participants reporting a successful treatment outcome (relative risk 1.39, 0.94 to 2.03). Several secondary outcomes favoured the active group, including shoulder pain and disability index function score, muscle strength, interference with activity, and quality of life.
Conclusion: A standardised programme of manual therapy and home exercise did not confer additional immediate benefits for pain and function compared with a realistic placebo treatment that controlled for therapists’ contact in middle aged to older adults with chronic rotator cuff disease. However, greater improvements were apparent at follow-up, particularly in shoulder function and strength, suggesting that benefits with active treatment take longer to manifest.
NIH Risk of Bias Tool
Quality Assessment of Controlled Intervention Studies
- Was the study described as randomized, a randomized trial, a randomized clinical trial, or an RCT
- Yes
- Was the method of randomization adequate (i.e., use of randomly generated assignment)?
- Yes
- Was the treatment allocation concealed (so that assignments could not be predicted)?
- Yes
- Were study participants and providers blinded to treatment group assignment?
- No
- Were the people assessing the outcomes blinded to the participants’ group assignments?
- Yes
- Were the groups similar at baseline on important characteristics that could affect outcomes (e.g., demographics, risk factors, co-morbid conditions)?
- Yes
- Was the overall drop-out rate from the study at endpoint 20% or lower of the number allocated to treatment?
- Yes
- Was the differential drop-out rate (between treatment groups) at endpoint 15 percentage points or lower?
- Yes
- Was there high adherence to the intervention protocols for each treatment group?
- Yes
- Were other interventions avoided or similar in the groups (e.g., similar background treatments)?
- Yes
- Were outcomes assessed using valid and reliable measures, implemented consistently across all study participants?
- Yes
- Did the authors report that the sample size was sufficiently large to be able to detect a difference in the main outcome between groups with at least 80% power?
- Yes
- Were outcomes reported or subgroups analyzed prespecified (i.e., identified before analyses were conducted)?
- Yes
- Were all randomized participants analyzed in the group to which they were originally assigned, i.e., did they use an intention-to-treat analysis?
- Yes
Key Finding #1
The treatment and placebo group demonstrated significant improvements at 11 weeks. There was no significant between group differences for shoulder pain, disability index score, and pain on movement. However, the active group demonstrated improvements in strength for self-reported and objective measures at the 11-week follow-up.
Key Finding #2
At the 22-week follow-up, the treatment group demonstrated significantly greater improvement in shoulder pain and disability index than the placebo group. They also had greater improvements in muscle strength, interference with ADLs, and health related quality of life.
Key Finding #3
The benefits of exercise and manual therapy for chronic rotator cuff disease are not immediate and become apparent over time.
Please provide your summary of the paper
This purpose of this paper was to determine whether a 10-week home exercise program and manual therapy from a physical therapist improved shoulder pain and function more than placebo treatment for patients with chronic (>3 months) rotator cuff disease.
There were 112 participants diagnosed with chronic rotator cuff disease who attended 10 physical therapy sessions over 10 weeks and the follow-up appointments at week 11 and 22. Participants were assigned to a home exercise program and manual therapy group or a placebo group who received a sham ultrasound therapy and non-therapeutic gel to the shoulder region for 10 minutes, with no exercises or manual therapy. The treatment group received interventions aimed at improving dynamic scapular control, strengthening scapular stabilizer and rotator cuff muscles, improving shoulder and thoracic posture, and increasing range of motion for thoracic extension. Soft tissue massage, passive mobilization of glenohumeral joint, scapular retraining and postural taping, spinal mobilization, and home exercises were provided to the treatment group. Both groups completed the 10 week session, then were instructed to continue their daily routine for an additional 12 weeks (HEP for treatment group, nothing for placebo group). Adherence to HEP in the treat group was tacked using a book log.
The primary outcomes were shoulder pain (NPRS) and disability index (SPADI). They also measured average pain with movement, interference with ADLs, patient perceived amount of weakness and stiffness, and health related quality of life. Isometric shoulder strength (abduction, IR, ER) was also assessed.
The results demonstrated that at the 11-week follow-up (immediately after intervention), both groups had similar results for pain and function. However, at the 22-week follow-up, the treatment group had greater improvements in pain, function, strength, interference with activities, and quality of life. These results signify that exercise and manual therapy benefits may take several weeks before patients feel the effects.
The authors discussed how these results may be due to the fact that symptoms of chronic rotator cuff disease change over time and patients often seek care when symptoms are the worst. The placebo effect was also discussed and how 90% of participants expected a moderate to large benefit from active treatment (positive expectation is associated with improved outcomes). They mentioned the need for further research on individualized chronic rotator cuff protocols and on benefits of different physical therapy routines combined with drug treatments.
Please provide your clinical interpretation of this paper. Include how this study may impact clinical practice and how the results can be implemented.
This study impacts clinical practice because it indicates that exercise and manual therapy take time for the benefits to accumulate. It is important to educate patients with chronic rotator cuff disease on this because it is vital to stay consistent with PT exercise protocol. When in consistent pain (mild or moderate), it can be easy to feel disappointed and quit when something isn’t working. However, this study demonstrates the importance of continuing exercise and manual therapy for long term reductions in pain and improvements in function and strength. It is important to note that the treatment group received a standardized program, which may not have been specific to the patient’s presentation, dysfunction, and pain. In practice, it is important to create an intervention plan that is specific to that patient and their impairments. The authors mention that physical therapy interventions may be best at improving function, and not necessarily pain. If pain is the primary impairment, treatments that reduce pain (i.e. cortisone injections) should be used. If pain and loss of function are the impairments, then pain-relieving drugs and manual therapy / exercise should be utilized.
