Clinical Trial: Randomized Clinical Trial of Rehabilitation for Subacromial Impingement Syndrome

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary: 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 Summary: 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.
Sponsor: Proaxis Therapy

Current Primary Outcome: Shoulder disability and pain [ Time Frame: 6 weeks and 3, 6,12 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Patient satisfaction Quality of life (SF-36) Additional healthcare utilization and medication [ Time Frame: 6 weeks, and 3, 6, 12 months ]
  • Patient perceived global rating of effect [ Time Frame: 6 weeks and 3 months ]


Original Secondary Outcome: Same as current

Information By: Proaxis Therapy

Dates:
Date Received: March 4, 2008
Date Started: February 2008
Date Completion:
Last Updated: March 26, 2013
Last Verified: March 2013