The Clinical Efficacy of Belting Stabilization for Shoulder Pain
Primary Purpose
Rotator Cuff Impingement Syndrome
Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Stabilization belt
Stabilization belt
Sponsored by
About this trial
This is an interventional treatment trial for Rotator Cuff Impingement Syndrome
Eligibility Criteria
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
Sites / Locations
- Holland Orthopaedic and Arthritic Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
True Stabilization Group
Sham Stabilization
Arm Description
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.
Patients receive sham stabilization. The sham procedure imitates the treatment without any true effect.
Outcomes
Primary Outcome Measures
The Primary outcome measure is a subjective measure, the Quick Disability of the Arm, Shoulder and Hand (QuickDASH)
Secondary Outcome Measures
The secondary subjective outcomes include a joint specific measure, the American shoulder and Elbow Surgeons (ASES) score, and the work limitation questionnaire (WLQ-25).
Full Information
NCT ID
NCT00826293
First Posted
January 20, 2009
Last Updated
July 9, 2013
Sponsor
Sunnybrook Health Sciences Centre
1. Study Identification
Unique Protocol Identification Number
NCT00826293
Brief Title
The Clinical Efficacy of Belting Stabilization for Shoulder Pain
Official Title
The Clinical Efficacy of Belting Stabilization for Shoulder Pain: A Double Blinded Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sunnybrook Health Sciences Centre
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Impingement Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
True Stabilization Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Sham Stabilization
Arm Type
Sham Comparator
Arm Description
Patients receive sham stabilization. The sham procedure imitates the treatment without any true effect.
Intervention Type
Procedure
Intervention Name(s)
Stabilization belt
Other Intervention Name(s)
Belt Stabilization
Intervention Description
Patients receive true stabilization.
Intervention Type
Procedure
Intervention Name(s)
Stabilization belt
Other Intervention Name(s)
Ineffective stabilization
Intervention Description
Patients receive sham stabilization.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helen Razmjou, PhD
Organizational Affiliation
Sunnybrook Health Sciences Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Holland Orthopaedic and Arthritic Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4Y 1H1
Country
Canada
12. IPD Sharing Statement
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The Clinical Efficacy of Belting Stabilization for Shoulder Pain
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