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

Phase 3

• Conditions: Shoulder Pain
• Interventions: Procedure: Physical therapy method called Supervised Exercises; Procedure: Radial Extracorporeal Shockwave Therapy

• Registration Number: NCT00653081
• Lead Sponsor: Ullevaal University Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2006-07
• Status Verified: 2007-01
• Primary Completion: 2007-09
• Study First Submitted: 2008-01-07
• Study First Submitted QC: 2008-04-03
• Last Update Submitted: 2008-04-03
• Study First Posted: 2008-04-04
• Last Update Posted: 2008-04-04
• Study Completion: 2008-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 104

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Physical therapy method called Supervised Exercises	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
B	Radial Extracorporeal Shockwave Therapy	Radial Shock Wave therapy performed at ulleval Hospital, once a week, 4-6 times, 3-5 points each time.

Primary Outcome Measures

Name	Time	Method
Shoulder Pain and Disability Index (SPADI)	Baseline, 6 weeks, 12 weeks, 18 weeks and 12 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Department for physical medicine and rehabilitation, Ullevaal University Hospital; 🇳🇴 Oslo, Norway