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

Study Overview
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Brief Summary
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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.

Official Title
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Treatment of Subacromial Shoulder Pain

Conditions
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Shoulder Impingement Syndrome, Subacromial Shoulder Pain

Intervention / Treatment
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* Device: Radial extracorporeal shock wave therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: sham rESWT<br> | Device: Radial extracorporeal shock wave therapy<br>* 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<br>* Other names: shock wave therapy;|
| Active Comparator: rESWT<br> | Device: Radial extracorporeal shock wave therapy<br>* 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<br>* Other names: shock wave therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Shoulder Pain and Disability Index (SPADI) |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health-related quality of life (Eq-5d) |  | 24 weeks and 1 year | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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shoulder, subacromial, impingement, tendinopathy, rESWT, shock wave, ESWT, RSWT