The Clinical Efficacy of Belting Stabilization for Shoulder Pain

Phase 1

Completed

• Conditions: Rotator Cuff Impingement Syndrome
• Interventions: Procedure: Stabilization belt

• Registration Number: NCT00826293
• Lead Sponsor: Sunnybrook Health Sciences Centre

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-01-20
• Study First Submitted QC: 2009-01-21
• Study First Posted: 2009-01-22
• Primary Completion: 2013-05
• Study Completion: 2013-06
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-09
• Last Update Posted: 2013-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham Stabilization	Stabilization belt	Patients receive sham stabilization. The sham procedure imitates the treatment without any true effect.
True Stabilization Group	Stabilization belt	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Holland Orthopaedic and Arthritic Centre; 🇨🇦 Toronto, Ontario, Canada