NCT01441830UnknownPhase 3
Treatment of Subacromial Shoulder Pain
Oslo University Hospital2 sites in 1 country150 target enrollmentStarted: September 1, 2011Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 3
- Sponsor
- Enrollment
- 150
- Locations
- 2
- Primary Endpoint
- Shoulder Pain and Disability Index (SPADI)
Study Overview
Brief Summary
The purpose of this study is to determine whether rESWT (radial extracorporeal shock wave therapy) combined with supervised exercises will improve function and reduce pain in subacromial shoulder pain compared with supervised exercises alone.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 25 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Dysfunction or pain on abduction
- •Pain on one of two isometric tests (abduction or external rotation)
- •Positive Hawkins sign
- •Normal passive glenohumeral range of motion
Exclusion Criteria
- •Previous surgery on affected shoulder
- •Instability
- •Total rupture of the rotator cuff (evaluated clinically or by US)
- •Clinical signs of a cervical syndrome
- •Infection in the area
- •Exclusion criteria cont.
- •Patients considered unable to fill out questionnaires or to go through the treatment
- •Use of anticoagulant drugs or bleeding disorder
- •Pregnancy
- •Previous experience of one of the study interventions
- •Corticosteroid injection in the past 6 weeks.
- •SPADI < 20
Outcomes
Primary Outcomes
Shoulder Pain and Disability Index (SPADI)
Time Frame: 24 weeks
Secondary Outcomes
- Return to work(6 weeks, 12 weeks, 24 weeks and 1 year)
- Pain and function measured on a 11 point Likert type scale(6 weeks, 12 weeks, 24 weeks and 1 year)
- Health-related quality of life (Eq-5d)(24 weeks and 1 year)
Investigators
Study Sites (2)
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