Overview

This trial is active, not recruiting.

Conditions shoulder impingement syndrome, subacromial shoulder pain
Treatment radial extracorporeal shock wave therapy
Phase phase 3
Sponsor Oslo University Hospital
Start date September 2011
End date May 2015
Trial size 150 participants
Trial identifier NCT01441830, 2011/5347

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Sham Comparator)
radial extracorporeal shock wave therapy rESWT
The shockwave treatment will be administered once a week for four weeks on one to three specific points (supraspinatus, infraspinatus or subscapular tendon)and with a pressure between 1,5-3 Bar
(Active Comparator)
radial extracorporeal shock wave therapy rESWT
The shockwave treatment will be administered once a week for four weeks on one to three specific points (supraspinatus, infraspinatus or subscapular tendon)and with a pressure between 1,5-3 Bar

Primary Outcomes

Measure
Shoulder Pain and Disability Index (SPADI)
time frame: 24 weeks

Secondary Outcomes

Measure
Health-related quality of life (Eq-5d)
time frame: 24 weeks and 1 year
Return to work
time frame: 6 weeks, 12 weeks, 24 weeks and 1 year
Pain and function measured on a 11 point Likert type scale
time frame: 6 weeks, 12 weeks, 24 weeks and 1 year

Eligibility Criteria

Male or female participants from 25 years up to 70 years old.

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

Additional Information

Official title Treatment of Subacromial Shoulder Pain
Trial information was received from ClinicalTrials.gov and was last updated in December 2014.
Information provided to ClinicalTrials.gov by Oslo University Hospital.