Radial Extracorporeal Shock Wave Therapy (rESWT) Treatment of Subacromial Shoulder Pain

Phase 3

• Conditions: Subacromial Shoulder Pain; Shoulder Impingement Syndrome
• Interventions: Device: Radial extracorporeal shock wave therapy

• Registration Number: NCT01441830
• Lead Sponsor: Oslo University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-09-15
• Study First Submitted QC: 2011-09-27
• Study First Posted: 2011-09-28
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-17
• Last Update Posted: 2014-12-18
• Primary Completion: 2015-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
rESWT	Radial extracorporeal shock wave therapy	-
sham rESWT	Radial extracorporeal shock wave therapy	-

Primary Outcome Measures

Name	Time	Method
Shoulder Pain and Disability Index (SPADI)	24 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Oslo University Hospital, Ulleval, department for physical medicine and rehabilitation; 🇳🇴 Oslo, Norway