Randomized Clinical Trial of Rehabilitation for Subacromial Impingement Syndrome

Study Overview
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Brief Summary
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The purpose of this randomized double-blind clinical trial is to determine the effectiveness of manual therapy for patients with subacromial impingement syndrome of the shoulder. We hypothesize that a combination of therapeutic exercise and manual therapy to the shoulder and spine will be more effective in reducing pain and shoulder disability at short-term (6 wk) and long-term (3, 6, 12 months) as compared to therapeutic exercise only.

Detailed Description
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Subacromial impingement syndrome (SAIS) is a frequent cause of shoulder pain. Clinical trials investigating the effectiveness of manual therapy have demonstrated improvements in outcomes when manual therapy has been added to a program of therapeutic exercise. However, the these clinical trials (3) have significant limitations and generalizability. Two of the three 3 trials had a small number of subjects (14 & 22 subjects) and all 3 trials had only short term follow up (<12 weeks) and used non-validated self report outcome measures. These limitations reduce the confidence with which clinicians can apply these results to the patients they treat with SAIS. Clear evidence is needed to justify the cost and clinician time required to perform manual therapy in the delivery of patient care. Therefore, the purpose of this randomized clinical trial is to examine the short-term and long-term effectiveness of manual therapy in addition to therapeutic exercise as compared to therapeutic exercise only in patients diagnosed with SAIS.

Official Title
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Randomized Clinical Trial of Rehabilitation for Subacromial Impingement Syndrome: A Comparison of Manual Therapy + Exercise to Exercise Only

Conditions
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Shoulder Impingement Syndrome

Intervention / Treatment
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* Other: Manual Therapy and Exercise
* Other: Exercise Only


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Symptoms associated with athletic activity (35% of patients) Diagnosis of shoulder impingement syndrome as evidence by all 3 criteria: Reproduction of symptoms with impingement test: either Hawkins- Kennedy or Neer Test Pain during active shoulder elevation at or above 60 degrees Weakness of rotator cuff or pain during the Empty Can test or during resisted shoulder external rotation Shoulder disability: 25/100 (0 = no disability) Able to understand written and spoken Exclusion Criteria: Severe pain; pain is > 7/10 on NPRS (0 = no pain) Shoulder surgery on affected shoulder Traumatic shoulder dislocation within the past 3 months Previous rehabilitation for this episode of shoulder pain Reproduction of shoulder pain with active or passive cervical motion Systemic inflammatory joint disease Global loss of passive shoulder ROM, indicative of adhesive capsulitis Full-thickness rotator cuff tear, as evidenced by any one of the following: Markedly reduced shoulder external rotation strength Drop arm test External rotation lag sign Lift off test Positive findings on MRI or ultrasonography

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Manual Therapy + Exercise | Other: Manual Therapy and Exercise<br>* Manual therapy to the thoracic spine and shoulder, and therapeutic exercise to the shoulder and spine applied in a prescribed progression of therapeutic exercise aimed at improving shoulder function.<br>* Other names: Manual Therapy and Therapeutic Exercise;|
| Active Comparator: 2<br>Exercise Only | Other: Exercise Only<br>* A prescribed progression of therapeutic exercise for the shoulder and spine aimed at improving shoulder function<br>* Other names: Therapeutic Exercise;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Shoulder disability and pain |  | 6 weeks and 3, 6,12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction Quality of life (SF-36) Additional healthcare utilization and medication |  | 6 weeks, and 3, 6, 12 months | 
| Patient perceived global rating of effect |  | 6 weeks and 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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shoulder pain, shoulder impingement syndrome, manual therapy, rehabilitation