Radial Extracorporeal Shock Wave Therapy (rESWT) Treatment of Subacromial Shoulder Pain
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ClinicalTrials.gov Identifier: NCT01441830 |
Recruitment Status
: Unknown
Verified December 2014 by Oslo University Hospital.
Recruitment status was: Active, not recruiting
First Posted
: September 28, 2011
Last Update Posted
: December 18, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Shoulder Impingement Syndrome Subacromial Shoulder Pain | Device: Radial extracorporeal shock wave therapy | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 150 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Treatment of Subacromial Shoulder Pain |
Study Start Date : | September 2011 |
Estimated Primary Completion Date : | May 2015 |

Arm | Intervention/treatment |
---|---|
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:
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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:
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- Shoulder Pain and Disability Index (SPADI) [ Time Frame: 24 weeks ]
- 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 ]

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Ages Eligible for Study: | 25 Years to 70 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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): NCT01441830
Norway | |
Oslo University Hospital, Ulleval, department for physical medicine and rehabilitation | |
Oslo, Norway, 0450 |
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 |
First Posted: | September 28, 2011 Key Record Dates |
Last Update Posted: | December 18, 2014 |
Last Verified: | December 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 Shoulder Injuries Wounds and Injuries |