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Sponsored by: |
Sunnybrook Health Sciences Centre |
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Information provided by: | Sunnybrook Health Sciences Centre |
ClinicalTrials.gov Identifier: | NCT00826293 |
Application of a belt for stabilization while exercising accelerate and optimize recovery in patients diagnosed with shoulder impingement syndrome.
Condition | Intervention | Phase |
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Rotator Cuff Impingement Syndrome |
Procedure: Stabilization belt |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | The Clinical Efficacy of Belting Stabilization for Shoulder Pain: A Double Blinded Randomized Clinical Trial |
Enrollment: | 64 |
Study Start Date: | January 2009 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Patients will be randomized to one of the two treatment groups (true stabilization vs. sham stabilization). Patients will be exercising with a belt that is expected to reduce impingement in the shoulder. |
Procedure: Stabilization belt
Patients receive true stabilization.
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2: Sham Comparator
Patients receive sham stabilization. The sham procedure imitates the treatment without any true effect.
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Procedure: Stabilization belt
Patients receive sham stabilization.
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Stabilization through belts is commonly used as an adjunct for treatment of musculoskeletal problems. Although this treatment is popular among clinicians, there is a paucity of evidence on its use for shoulder pathology. The objective of this double-blinded longitudinal randomized controlled trial (RCT) is to determine the clinical efficacy of stabilization belting applied to patients receiving rehabilitation treatment for shoulder impingement syndrome. The study population will include patients who have been referred to the physiotherapy department of the Holland Orthopaedic & Arthritic Centre for conservative treatment. Patients will be randomized into the treatment and control groups. The primary outcome measure is the Quick Disabilities of Arm, Shoulder and Hand (QuickDASH) questionnaire.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Helen Razmjou, PhD (C) ( Sunnybrook Health Sceinces Centre ) |
Study ID Numbers: | 224-2008 |
Study First Received: | January 20, 2009 |
Last Updated: | January 21, 2009 |
ClinicalTrials.gov Identifier: | NCT00826293 History of Changes |
Health Authority: | Canada: Ethics Review Committee |
Signs and Symptoms Musculoskeletal Diseases Shoulder Pain |
Joint Diseases Pain Arthralgia |
Signs and Symptoms Pathologic Processes Disease Musculoskeletal Diseases Shoulder Pain |
Joint Diseases Syndrome Pain Arthralgia |