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

Shoulder Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00653081
• Other study ID #: VT
• Secondary ID: rESWT
• Status: Active, not recruiting
• Phase: Phase 3
• First received: January 7, 2008
• Last updated: April 3, 2008
• Start date: July 2006
• Est. completion date: December 2008

Study information

• Verified date: January 2007
• Source: Ullevaal University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research EthicsNorway: Data Protection Authority
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 104
• Est. completion date: December 2008
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Shoulder Impingement Syndrome
• Shoulder Pain

Intervention

Procedure:
• Physical therapy method called Supervised Exercises
Performed at ullevaal Hospital, 45 min each time, 2-3 times pr week in max 12 weeks
• Radial Extracorporeal Shockwave Therapy
Radial Shock Wave therapy performed at ulleval Hospital, once a week, 4-6 times, 3-5 points each time.

Locations

Country	Name	City	State
Norway	Department for physical medicine and rehabilitation, Ullevaal University Hospital	Oslo

Sponsors (3)

Lead Sponsor	Collaborator
Ullevaal University Hospital	South Eastern Area Health Service, University of Oslo

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Shoulder Pain and Disability Index (SPADI)		Baseline, 6 weeks, 12 weeks, 18 weeks and 12 months	No
Secondary	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	No