The Clinical Efficacy of Belting Stabilization for Shoulder Pain

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

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

Study Overview

• Status: Completed
• Conditions: Rotator Cuff Impingement Syndrome
• Intervention / Treatment: Procedure: Stabilization belt; Procedure: Stabilization belt

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 Type: Interventional
• Enrollment (Actual): 64
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M4Y 1H1
      • Holland Orthopaedic and Arthritic Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: True Stabilization Group; 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; Patients receive true stabilization.; Other Names: Belt Stabilization; Procedure: Stabilization belt; Patients receive sham stabilization.; Other Names: Ineffective stabilization
Sham Comparator: Sham Stabilization; Patients receive sham stabilization. The sham procedure imitates the treatment without any true effect.	Procedure: Stabilization belt; Patients receive true stabilization.; Other Names: Belt Stabilization; Procedure: Stabilization belt; Patients receive sham stabilization.; Other Names: Ineffective stabilization

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Sunnybrook Health Sciences Centre
• Investigators: Principal Investigator: Helen Razmjou, PhD, Sunnybrook Health Sciences Centre

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: January 20, 2009
• First Submitted That Met QC Criteria: January 21, 2009
• First Posted (Estimate): January 22, 2009

Study Record Updates

• Last Update Posted (Estimate): July 11, 2013
• Last Update Submitted That Met QC Criteria: July 9, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Arthralgia; Shoulder Impingement Syndrome; Shoulder Pain
• Other Study ID Numbers: 224-2008