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The Clinical Efficacy of Belting Stabilization for Shoulder Pain

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ClinicalTrials.gov Identifier: NCT00826293
Recruitment Status : Completed
First Posted : January 22, 2009
Last Update Posted : July 11, 2013
Sponsor:
Information provided by (Responsible Party):
Dr. Helen Razmjou, Sunnybrook Health Sciences Centre

January 20, 2009
January 22, 2009
July 11, 2013
January 2009
May 2013   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00826293 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
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.
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.
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Rotator Cuff Impingement Syndrome
  • Procedure: Stabilization belt
    Patients receive true stabilization.
    Other Name: Belt Stabilization
  • Procedure: Stabilization belt
    Patients receive sham stabilization.
    Other Name: Ineffective stabilization
  • 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.
    Intervention: Procedure: Stabilization belt
  • Sham Comparator: Sham Stabilization
    Patients receive sham stabilization. The sham procedure imitates the treatment without any true effect.
    Intervention: Procedure: Stabilization belt
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
64
Same as current
June 2013
May 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT00826293
224-2008
No
Not Provided
Not Provided
Dr. Helen Razmjou, Sunnybrook Health Sciences Centre
Sunnybrook Health Sciences Centre
Not Provided
Principal Investigator: Helen Razmjou, PhD Sunnybrook Health Sciences Centre
Sunnybrook Health Sciences Centre
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP