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Clinical Trials/NCT01441830
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

Sponsor
Oslo University Hospital
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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