Supervised Exercises Compared With Radial Extracorporal Shock Wave Therapy (rESWT) in Patients With SIS
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| ClinicalTrials.gov Identifier: NCT00653081 |
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Recruitment Status : Unknown
Verified January 2007 by Ullevaal University Hospital.
Recruitment status was: Active, not recruiting
First Posted : April 4, 2008
Last Update Posted : April 4, 2008
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Shoulder Pain | Procedure: Physical therapy method called Supervised Exercises Procedure: Radial Extracorporeal Shockwave Therapy | Phase 3 |
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 (Clinical Trial) |
| Actual Enrollment : | 104 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (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 |
| Study Start Date : | July 2006 |
| Actual Primary Completion Date : | September 2007 |
| Estimated Study Completion Date : | December 2008 |
| Arm | Intervention/treatment |
|---|---|
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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
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Procedure: Physical therapy method called Supervised Exercises
Performed at ullevaal Hospital, 45 min each time, 2-3 times pr week in max 12 weeks |
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Active Comparator: B
Radial Shock Wave therapy performed at ulleval Hospital, once a week, 4-6 times, 3-5 points each time.
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Procedure: Radial Extracorporeal Shockwave Therapy
Radial Shock Wave therapy performed at ulleval Hospital, once a week, 4-6 times, 3-5 points each time. |
- Shoulder Pain and Disability Index (SPADI) [ Time Frame: Baseline, 6 weeks, 12 weeks, 18 weeks and 12 months ]
- 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 ]
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| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00653081
| 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 |
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 |
| First Posted: | April 4, 2008 Key Record Dates |
| Last Update Posted: | April 4, 2008 |
| Last Verified: | January 2007 |
Keywords provided by Ullevaal University Hospital:
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Shoulder pain Supervised Exercises Radial Shock Wave Therapy |
Additional relevant MeSH terms:
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Shoulder Pain Shoulder Impingement Syndrome Arthralgia Joint Diseases Musculoskeletal Diseases Pain |
Neurologic Manifestations Nervous System Diseases Signs and Symptoms Shoulder Injuries Wounds and Injuries |