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

April 3, 2008 updated by: Ullevaal University Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

104

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway, 0407
        • Department for physical medicine and rehabilitation, Ullevaal University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A
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
Performed at ullevaal Hospital, 45 min each time, 2-3 times pr week in max 12 weeks
Active Comparator: B
Radial Shock Wave therapy performed at ulleval Hospital, once a week, 4-6 times, 3-5 points each time.
Procedure: Radial Extracorporeal Shockwave Therapy
Radial Shock Wave therapy performed at ulleval Hospital, once a week, 4-6 times, 3-5 points each time.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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.
Time Frame: Baseline, 6 weeks, 12 weeks, 18 weeks and 12 months
Baseline, 6 weeks, 12 weeks, 18 weeks and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ullevaal University Hospital

Collaborators

University of Oslo
South Eastern Area Health Service

Investigators

  • Principal Investigator: Kaia Engebretsen, PhD, Dep of Physical Medicine and rehabilitation, Ullevaal University Hospital, Oslo, Norway

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Primary Completion (Actual)

September 1, 2007

Study Completion (Anticipated)

December 1, 2008

Study Registration Dates

First Submitted

January 7, 2008

First Submitted That Met QC Criteria

April 3, 2008

First Posted (Estimate)

April 4, 2008

Study Record Updates

Last Update Posted (Estimate)

April 4, 2008

Last Update Submitted That Met QC Criteria

April 3, 2008

Last Verified

January 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VT
  • rESWT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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