An interventional study of Manual Therapy and Exercise and Exercise Only in Shoulder Impingement Syndrome, sponsored by Proaxis Therapy. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2013-03-28.
Sponsored by Proaxis Therapy · Not applicable, Interventional, and Treatment
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.
312 studies on the registry are indexed under Shoulder Impingement Syndrome; 58 are open to participants now.
This study's enrollment of 109 is above the median of 54 across 267 interventional studies indexed under Shoulder Impingement Syndrome.
Browse Shoulder Impingement Syndrome studies →This is the only study on the registry with Proaxis Therapy as lead sponsor.
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Diagnosis of shoulder impingement syndrome as evidence by all 3 criteria:
Exclusion Criteria:
Full-thickness rotator cuff tear, as evidenced by any one of the following:
Manual Therapy + Exercise
Other: Manual Therapy and Exercise
Exercise Only
Other: Exercise Only
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.
Also known as: Manual Therapy and Therapeutic Exercise
A prescribed progression of therapeutic exercise for the shoulder and spine aimed at improving shoulder function
Also known as: Therapeutic Exercise
Shoulder disability and pain
Time frame: 6 weeks and 3, 6,12 months
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
The record gives a start of Feb 2008, a primary completion of Sep 2012 and a completion of Sep 2012. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Mar 2013. You cannot join it, but the record below documents what was studied.
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Shoulder Impingement Syndrome →