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Radial Extracorporeal Shock Wave Therapy (rESWT) Treatment of Subacromial Shoulder Pain
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2014 by Oslo University Hospital.
Recruitment status was: Active, not recruiting
Recruitment status was: Active, not recruiting
Sponsor:
Oslo University Hospital
Information provided by (Responsible Party):
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01441830
First received: September 15, 2011
Last updated: December 17, 2014
Last verified: December 2014
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Purpose
The purpose of this study is to determine whether rESWT (radial extracorporeal shock wave therapy) combined with supervised exercises will improve function and reduce pain in subacromial shoulder pain compared with supervised exercises alone.
| Condition | Intervention | Phase |
|---|---|---|
| Shoulder Impingement Syndrome Subacromial Shoulder Pain | Device: Radial extracorporeal shock wave therapy | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Treatment of Subacromial Shoulder Pain |
Resource links provided by NLM:
Further study details as provided by Oslo University Hospital:
Primary Outcome Measures:
- Shoulder Pain and Disability Index (SPADI) [ Time Frame: 24 weeks ]
Secondary Outcome Measures:
- Health-related quality of life (Eq-5d) [ Time Frame: 24 weeks and 1 year ]
- Return to work [ Time Frame: 6 weeks, 12 weeks, 24 weeks and 1 year ]
- Pain and function measured on a 11 point Likert type scale [ Time Frame: 6 weeks, 12 weeks, 24 weeks and 1 year ]
| Estimated Enrollment: | 150 |
| Study Start Date: | September 2011 |
| Estimated Primary Completion Date: | May 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Sham Comparator: sham rESWT |
Device: Radial extracorporeal shock wave therapy
The shockwave treatment will be administered once a week for four weeks on one to three specific points (supraspinatus, infraspinatus or subscapular tendon)and with a pressure between 1,5-3 Bar
Other Names:
|
| Active Comparator: rESWT |
Device: Radial extracorporeal shock wave therapy
The shockwave treatment will be administered once a week for four weeks on one to three specific points (supraspinatus, infraspinatus or subscapular tendon)and with a pressure between 1,5-3 Bar
Other Names:
|
Eligibility| Ages Eligible for Study: | 25 Years to 70 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Dysfunction or pain on abduction
- Pain on one of two isometric tests (abduction or external rotation)
- Positive Hawkins sign
- Normal passive glenohumeral range of motion
Exclusion Criteria:
- Previous surgery on affected shoulder
- Instability
- Total rupture of the rotator cuff (evaluated clinically or by US)
- Clinical signs of a cervical syndrome
- Infection in the area
- Exclusion criteria cont.
- Patients considered unable to fill out questionnaires or to go through the treatment
- Use of anticoagulant drugs or bleeding disorder
- Pregnancy
- Previous experience of one of the study interventions
- Corticosteroid injection in the past 6 weeks.
- SPADI < 20
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01441830
Please refer to this study by its ClinicalTrials.gov identifier: NCT01441830
Locations
| Norway | |
| Oslo University Hospital, Ulleval, department for physical medicine and rehabilitation | |
| Oslo, Norway, 0450 | |
Sponsors and Collaborators
Oslo University Hospital
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Oslo University Hospital |
| ClinicalTrials.gov Identifier: | NCT01441830 History of Changes |
| Other Study ID Numbers: |
2011/5347 |
| Study First Received: | September 15, 2011 |
| Last Updated: | December 17, 2014 |
Keywords provided by Oslo University Hospital:
|
shoulder subacromial impingement tendinopathy |
rESWT shock wave ESWT RSWT |
Additional relevant MeSH terms:
|
Shoulder Pain Shoulder Impingement Syndrome Arthralgia Joint Diseases Musculoskeletal Diseases |
Pain Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on June 23, 2017