Shoulder Impingement Syndrome Clinical Trial
Official title:
Randomized Clinical Trial of Rehabilitation for Subacromial Impingement Syndrome: A Comparison of Manual Therapy + Exercise to Exercise Only
Verified date | March 2013 |
Source | Proaxis Therapy |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 109 |
Est. completion date | September 2012 |
Est. primary completion date | September 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Symptoms associated with athletic activity (35% of patients) - Diagnosis of shoulder impingement syndrome as evidence by all 3 criteria: 1. Reproduction of symptoms with impingement test: either Hawkins- Kennedy or Neer Test 2. Pain during active shoulder elevation at or above 60 degrees 3. 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: 1. Markedly reduced shoulder external rotation strength 2. Drop arm test 3. External rotation lag sign 4. Lift off test 5. Positive findings on MRI or ultrasonography |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Proaxis Therapy | Greenville | South Carolina |
Lead Sponsor | Collaborator |
---|---|
Proaxis Therapy | Arcadia University, National Athletic Trainers’ Association Research & Education Foundation (NATA Foundation), Virginia Commonwealth University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Shoulder disability and pain | 6 weeks and 3, 6,12 months | No | |
Secondary | Patient satisfaction Quality of life (SF-36) Additional healthcare utilization and medication | 6 weeks, and 3, 6, 12 months | No | |
Secondary | Patient perceived global rating of effect | 6 weeks and 3 months | No |
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