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Clinical Trials/NCT01441830
NCT01441830
Unknown
Phase 3

Treatment of Subacromial Shoulder Pain

Oslo University Hospital1 site in 1 country150 target enrollmentSeptember 2011

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Shoulder Impingement Syndrome
Sponsor
Oslo University Hospital
Enrollment
150
Locations
1
Primary Endpoint
Shoulder Pain and Disability Index (SPADI)
Last Updated
11 years ago

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.

Registry
clinicaltrials.gov
Start Date
September 2011
End Date
May 2015
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Oslo University Hospital
Responsible Party
Sponsor

Eligibility Criteria

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

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)

Study Sites (1)

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