The Clinical Efficacy of Belting Stabilization for Shoulder Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00826293
Recruitment Status : Completed
First Posted : January 22, 2009
Last Update Posted : July 11, 2013
Information provided by (Responsible Party):
Dr. Helen Razmjou, 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.

Condition or disease Intervention/treatment Phase
Rotator Cuff Impingement Syndrome Procedure: Stabilization belt Phase 1

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  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Clinical Efficacy of Belting Stabilization for Shoulder Pain: A Double Blinded Randomized Clinical Trial
Study Start Date : January 2009
Actual Primary Completion Date : May 2013
Actual Study Completion Date : June 2013

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 Name: Belt Stabilization

Sham Comparator: Sham Stabilization
Patients receive sham stabilization. The sham procedure imitates the treatment without any true effect.
Procedure: Stabilization belt
Patients receive sham stabilization.
Other Name: Ineffective stabilization

Primary Outcome Measures :
  1. The Primary outcome measure is a subjective measure, the Quick Disability of the Arm, Shoulder and Hand (QuickDASH) [ Time Frame: Outcome measures are collected before the initial treatment, at 3 weeks, and at 6 weeks following the initial treatment ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00826293

Canada, Ontario
Holland Orthopaedic and Arthritic Centre
Toronto, Ontario, Canada, M4Y 1H1
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Principal Investigator: Helen Razmjou, PhD Sunnybrook Health Sciences Centre

Responsible Party: Dr. Helen Razmjou, Dr. Helen Razmjou, Physical Therapist, Sunnybrook Health Sciences Centre Identifier: NCT00826293     History of Changes
Other Study ID Numbers: 224-2008
First Posted: January 22, 2009    Key Record Dates
Last Update Posted: July 11, 2013
Last Verified: July 2013

Additional relevant MeSH terms:
Shoulder Pain
Shoulder Impingement Syndrome
Joint Diseases
Musculoskeletal Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Shoulder Injuries
Wounds and Injuries