Overview

This trial is active, not recruiting.

Condition shoulder pain
Treatments physical therapy method called supervised exercises, radial extracorporeal shockwave therapy
Phase phase 3
Sponsor Ullevaal University Hospital
Collaborator South Eastern Area Health Service
Start date July 2006
End date September 2007
Trial size 104 participants
Trial identifier NCT00653081, VT, rESWT

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
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
physical therapy method called supervised exercises
Performed at ullevaal Hospital, 45 min each time, 2-3 times pr week in max 12 weeks
(Active Comparator)
Radial Shock Wave therapy performed at ulleval Hospital, once a week, 4-6 times, 3-5 points each time.
radial extracorporeal shockwave therapy
Radial Shock Wave therapy performed at ulleval Hospital, once a week, 4-6 times, 3-5 points each time.

Primary Outcomes

Measure
Shoulder Pain and Disability Index (SPADI)
time frame: Baseline, 6 weeks, 12 weeks, 18 weeks and 12 months

Secondary Outcomes

Measure
Pain intensity labelled "no pain" and "severe pain" at its extremes, are measured on nine point scales for activity and rest during last week.
time frame: Baseline, 6 weeks, 12 weeks, 18 weeks and 12 months

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

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.

Additional Information

Official title Supervised Exercises Compared With Radial Extracorporal Shock Wave Therapy (rESWT) in Patients With Subacromial Impingement Syndrome: A Single Blind Clinical Randomized Study
Principal investigator Kaia Engebretsen, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2008.
Information provided to ClinicalTrials.gov by Ullevaal University Hospital.