The Clinical Efficacy of Belting Stabilization for Shoulder Pain

Study Overview
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Brief Summary
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Application of a belt for stabilization while exercising accelerate and optimize recovery in patients diagnosed with shoulder impingement syndrome.

Detailed Description
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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.

Official Title
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The Clinical Efficacy of Belting Stabilization for Shoulder Pain: A Double Blinded Randomized Clinical Trial

Conditions
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Rotator Cuff Impingement Syndrome

Intervention / Treatment
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* Procedure: Stabilization belt
* Procedure: Stabilization belt


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of impingement syndrome or post-surgical stiffness with an abnormal scapulothoracic rhythm Exclusion Criteria: Inability to speak or read English Evidence of major joint trauma causing fracture Infection Underlying metabolic or inflammatory disease Avascular necrosis Frozen shoulder Major medical illness Psychiatric illness that precluded informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: True Stabilization Group<br>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 of the rotator cuff tendons. | Procedure: Stabilization belt<br>* Patients receive true stabilization.<br>* Other names: Belt Stabilization;|
| Sham Comparator: Sham Stabilization<br>Patients receive sham stabilization. The sham procedure imitates the treatment without any true effect. | Procedure: Stabilization belt<br>* Patients receive sham stabilization.<br>* Other names: Ineffective stabilization;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Primary outcome measure is a subjective measure, the Quick Disability of the Arm, Shoulder and Hand (QuickDASH) |  | Outcome measures are collected before the initial treatment, at 3 weeks, and at 6 weeks following the initial treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The secondary subjective outcomes include a joint specific measure, the American shoulder and Elbow Surgeons (ASES) score, and the work limitation questionnaire (WLQ-25). |  | Outcome measures are collected before the initial treatment, at 3 weeks, and at 6 weeks following the initial treatment |