Supervised Exercises Compared With Radial Extracorporal Shock Wave Therapy (rESWT) in Patients With SIS

Study Overview
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Brief Summary
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The purpose of this study is to compare Supervised Exercises with another non-operative frequently used treatment, Radial Extracorporeal Shockwave Therapy (rESWT), for patients with subacromial impingement syndrome.

Detailed Description
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Shoulder pain is, in succession to back, neck, and knee, the fourth most frequently localized musculoskeletal pain reported by patients to general practitioners and physical therapists. A majority of shoulder complaints lasts for more than three months and become chronic. Few of the different interventions for rehabilitation of chronic shoulder pain, have documented effect. Patients with shoulder pain are associated with significant disability and loss of quality of life which interfere with activities related to daily living. Supervised exercises, a treatment method which has been compared to surgery and placebo laser, is one that has documented effect for both short (6 months) and long time (2½ years). The purpose of this study was to compare Supervised Exercises with another non-operative common used treatment method for these patients, radial Extracorporeal Shockwave Therapy (rESWT). The study is designed as a randomised, single blind clinical controlled study.

Official Title
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Supervised Exercises Compared With Radial Extracorporal Shock Wave Therapy (rESWT) in Patients With Subacromial Impingement Syndrome: A Single Blind Clinical Randomized Study

Conditions
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Shoulder Pain

Intervention / Treatment
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* Procedure: Physical therapy method called Supervised Exercises
* Procedure: Radial Extracorporeal Shockwave Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subacromial shoulder pain lasting for at least three months and age between 18 and 70 years. Dysfunction or pain on abduction Had a normal passive glenohumeral range of movement Pain during two of three isometric tests (abduction, external- or internal rotation at 0º or 30º) Positive Hawkins-Kennedys test. Exclusion Criteria: Shoulder pain bilateral (both shoulders required treatment) Earlier operated in affected shoulder Had multidirectional instability Had the cervical syndrome Rheumatoid arthritis Clinical and radiological findings indicating glenohumeral - or acromioclavicular joint pathology Not able to understand spoken or written Norwegian Considerable emotional distress Needed anticoagulant medicine Being pregnant Had had Shock Wave Therapy or Supervised Exercises before.

Ages Eligible for Study
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Minimum Age: 18 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>Supervised Exercises performed at ulleval Hospital for patients with shoulder pain. Dosage: 45 minutes each time, max 2-3 times a week in max 12 weeks | Procedure: Physical therapy method called Supervised Exercises<br>* Performed at ullevaal Hospital, 45 min each time, 2-3 times pr week in max 12 weeks<br>|
| Active Comparator: B<br>Radial Shock Wave therapy performed at ulleval Hospital, once a week, 4-6 times, 3-5 points each time. | Procedure: Radial Extracorporeal Shockwave Therapy<br>* Radial Shock Wave therapy performed at ulleval Hospital, once a week, 4-6 times, 3-5 points each time.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Shoulder Pain and Disability Index (SPADI) |  | Baseline, 6 weeks, 12 weeks, 18 weeks and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity labelled no pain and severe pain at its extremes, are measured on nine point scales for activity and rest during last week. |  | Baseline, 6 weeks, 12 weeks, 18 weeks and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Shoulder pain, Supervised Exercises, Radial Shock Wave Therapy