Randomized Clinical Trial of Rehabilitation for Subacromial Impingement Syndrome
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Shoulder Impingement Syndrome |
Other: Manual Therapy and Exercise Other: Exercise Only |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver) Primary Purpose: Treatment |
| Official Title: | Randomized Clinical Trial of Rehabilitation for Subacromial Impingement Syndrome: A Comparison of Manual Therapy + Exercise to Exercise Only |
- Shoulder disability and pain [ Time Frame: 6 weeks and 3, 6,12 months ] [ Designated as safety issue: No ]
- Patient satisfaction Quality of life (SF-36) Additional healthcare utilization and medication [ Time Frame: 6 weeks, and 3, 6, 12 months ] [ Designated as safety issue: No ]
- Patient perceived global rating of effect [ Time Frame: 6 weeks and 3 months ] [ Designated as safety issue: No ]
| Enrollment: | 109 |
| Study Start Date: | February 2008 |
| Study Completion Date: | September 2012 |
| Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Manual Therapy + Exercise
|
Other: Manual Therapy and Exercise
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.
Other Name: Manual Therapy and Therapeutic Exercise
|
|
Active Comparator: 2
Exercise Only
|
Other: Exercise Only
A prescribed progression of therapeutic exercise for the shoulder and spine aimed at improving shoulder function
Other Name: Therapeutic Exercise
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, South Carolina | |
| Proaxis Therapy | |
| Greenville, South Carolina, United States, 29607 | |
| Principal Investigator: | Charles A Thigpen, PhD, PT, ATC | University of North Florida |
| Principal Investigator: | Lori A Michener, PhD, PT, ATC | Virginia Commonwealth University |
| Principal Investigator: | Phil McClure, PhD, PT | Arcadia University |
| Study Director: | Angela R Tate, PhD, PT | Arcadia University |
More Information
Additional Information:
No publications provided
| Responsible Party: | Chuck Thigpen, Clinical Research Scientist, Proaxis Therapy |
| ClinicalTrials.gov Identifier: | NCT00633451 History of Changes |
| Other Study ID Numbers: | 07-173 |
| Study First Received: | March 4, 2008 |
| Last Updated: | March 26, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Proaxis Therapy:
|
shoulder pain shoulder impingement syndrome manual therapy rehabilitation |
Additional relevant MeSH terms:
|
Shoulder Impingement Syndrome Joint Diseases Musculoskeletal Diseases |
ClinicalTrials.gov processed this record on May 16, 2013