The Clinical Efficacy of Belting Stabilization for Shoulder Pain

Rotator Cuff Impingement Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00826293
• Other study ID #: 224-2008
• Status: Completed
• Phase: Phase 1
• First received: January 20, 2009
• Last updated: July 9, 2013
• Start date: January 2009
• Est. completion date: June 2013

Study information

• Verified date: July 2013
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: June 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rotator Cuff Impingement Syndrome
• Shoulder Pain

Intervention

Procedure:
• Stabilization belt
Patients receive true stabilization.
• Stabilization belt
Patients receive sham stabilization.

Locations

Country	Name	City	State
Canada	Holland Orthopaedic and Arthritic Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No