| March 4, 2008 |
| February 17, 2009 |
| February 2008 |
| January 2010 (final data collection date for primary outcome measure) |
| Shoulder disability and pain [ Time Frame: 6 weeks and 3, 6,12 months ] [ Designated as safety issue: No ] |
| Same as current |
| Complete list of historical versions of study NCT00633451 on ClinicalTrials.gov Archive Site |
- 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 ]
|
| Same as current |
| |
| Randomized Clinical Trial of Rehabilitation for Subacromial Impingement Syndrome |
| Randomized Clinical Trial of Rehabilitation for Subacromial Impingement Syndrome: A Comparison of Manual Therapy + Exercise to Exercise Only |
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. |
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. |
| |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Caregiver), Active Control, Parallel Assignment, Efficacy Study |
| Shoulder Impingement Syndrome |
- Other: Manual Therapy and Exercise
- Other: Exercise Only
|
- Experimental: Manual Therapy + Exercise
- Active Comparator: Exercise Only
|
| |
| |
| Recruiting |
| 100 |
| January 2011 |
| January 2010 (final data collection date for primary outcome measure) |
Inclusion Criteria:
Exclusion Criteria:
|
| Both |
| 18 Years to 75 Years |
| No |
|
|
| United States |
| |
| NCT00633451 |
| Charles A Thigpen, PT, PhD, ATC Clinical Research Scientist, Proaxis Therapy |
| 07-173 |
| Proaxis Therapy |
- Virginia Commonwealth University
- Arcadia University
- National Athletic Training Association Research and Education Foundation
|
| 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 |
|
|
| Proaxis Therapy |
| February 2009 |