Supervised Exercises Compared With Radial Extracorporal Shock Wave Therapy (rESWT) in Patients With SIS
Recruitment status was Active, not recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Shoulder Pain |
Procedure: Physical therapy method called Supervised Exercises Procedure: Radial Extracorporeal Shockwave Therapy |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Supervised Exercises Compared With Radial Extracorporal Shock Wave Therapy (rESWT) in Patients With Subacromial Impingement Syndrome: A Single Blind Clinical Randomized Study |
- Shoulder Pain and Disability Index (SPADI) [ Time Frame: Baseline, 6 weeks, 12 weeks, 18 weeks and 12 months ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
| Enrollment: | 104 |
| Study Start Date: | July 2006 |
| Estimated Study Completion Date: | December 2008 |
| Primary Completion Date: | September 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| Norway | |
| Department for physical medicine and rehabilitation, Ullevaal University Hospital | |
| Oslo, Norway, 0407 | |
| Principal Investigator: | Kaia Engebretsen, PhD | Dep of Physical Medicine and rehabilitation, Ullevaal University Hospital, Oslo, Norway |
More Information
No publications provided by Ullevaal University Hospital
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | University of Oslo, South Eastern Area Health Service |
| ClinicalTrials.gov Identifier: | NCT00653081 History of Changes |
| Other Study ID Numbers: | VT, rESWT |
| Study First Received: | January 7, 2008 |
| Last Updated: | April 3, 2008 |
| Health Authority: | Norway:National Committee for Medical and Health Research Ethics Norway: Data Protection Authority |
Keywords provided by Ullevaal University Hospital:
|
Shoulder pain Supervised Exercises Radial Shock Wave Therapy |
Additional relevant MeSH terms:
|
Shock Shoulder Pain Shoulder Impingement Syndrome Pathologic Processes Arthralgia |
Joint Diseases Musculoskeletal Diseases Pain Signs and Symptoms |
ClinicalTrials.gov processed this record on May 16, 2013