The Clinical Efficacy of Belting Stabilization for Shoulder Pain
1 other identifier
interventional
64
1 country
1
Brief Summary
Application of a belt for stabilization while exercising accelerate and optimize recovery in patients diagnosed with shoulder impingement syndrome.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jan 2009
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2009
CompletedFirst Submitted
Initial submission to the registry
January 20, 2009
CompletedFirst Posted
Study publicly available on registry
January 22, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedJuly 11, 2013
July 1, 2013
4.3 years
January 20, 2009
July 9, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (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).
Outcome measures are collected before the initial treatment, at 3 weeks, and at 6 weeks following the initial treatment
Study Arms (2)
True Stabilization Group
ACTIVE COMPARATORPatients 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.
Sham Stabilization
SHAM COMPARATORPatients receive sham stabilization. The sham procedure imitates the treatment without any true effect.
Interventions
Patients receive true stabilization.
Eligibility Criteria
You may qualify if:
- Diagnosis of impingement syndrome or post-surgical stiffness with an abnormal scapulothoracic rhythm
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Holland Orthopaedic and Arthritic Centre
Toronto, Ontario, M4Y 1H1, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Helen Razmjou, PhD
Sunnybrook Health Sciences Centre
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr. Helen Razmjou, Physical Therapist
Study Record Dates
First Submitted
January 20, 2009
First Posted
January 22, 2009
Study Start
January 1, 2009
Primary Completion
May 1, 2013
Study Completion
June 1, 2013
Last Updated
July 11, 2013
Record last verified: 2013-07