Ultrasound Guided Needling Versus Ultrasound Guided Corticosteroid Injection Alone, a Randomized Controlled Trial.
NCT ID: NCT01538758
Last Updated: 2012-07-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
80 participants
INTERVENTIONAL
2012-07-31
2014-07-31
Brief Summary
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Detailed Description
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Calcifying tendinitis is regarded as a self-healing condition with usually spontaneous resolution of the calcifications. But some patients have chronic or recurrent pain and disability of the shoulder which requires treatment. The treatment should be minimally invasive and effective in short and long term. Symptomatic treatment is indicated first using non-steroidal anti-inflammatory drugs, therapeutic exercise and non ultrasound guided subacromial corticosteroids injection.
The role of corticosteroid injections is unknown due to the lack of good studies. Family doctors and orthopaedic surgeons inject corticosteroids in the shoulder without the guidance of ultrasound; with this method accurate needle placement in the subacromial bursa is not possible. When this treatment fails other therapeutical methods can be used. Ultrasound guided needling is a percutaneous technique of fragmentation or extraction of calcifications in the rotator cuff tendon.
Literature shows favourable results but only a few randomized controlled trials were executed. Randomised controlled trials are needed to give more insight in the effectiveness of us guided needling. Comparing two groups of patients treated with us guided corticosteroid injection and one group combined with us guided needling can provide information of the usefulness of us guided needling.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Us guided needling
Us guided needling is a therapeutical technique treating calcifying tendinitis of the shoulder. Calcifications in the rotator cuff tendon are visualised with ultrasound. Under ultrasound guidance a 20 gauge needle is inserted in the calcification. Lidocaine 1% in a 1cc syringe is injected in the calcification and aspirated. The calcification is flushed until the fluid is clear. Sometimes it is not possible to flush the calcification. In this case the calcification will be fragmented.
After flushing or fragmentation of the calcification, 20 mg triamcinolone with 1cc lidocaine 1% will be injected in de subacromial bursa under us guidance.
Us guided needling
Us guided needling is a therapeutical technique treating calcifying tendinitis of the shoulder. Calcifications in the rotator cuff tendon are visualised with ultrasound. Under ultrasound guidance a 20 gauge needle is inserted in the calcification. Lidocaine 1% in a 1cc syringe is injected in the calcification and aspirated. The calcification is flushed until the fluid is clear. Sometimes it is not possible to flush the calcification. In this case the calcification will be fragmented.
After flushing or fragmentation of the calcification, 20 mg triamcinolone with 1cc lidocaine 1% will be injected in de subacromial bursa under us guidance.
corticosteroid injection
Us guided subacromial bursa injection with 20 mg triamcinolone with 1cc lidocaine 1%.
corticosteroid injection
Us guided subacromial bursa injection with 20 mg triamcinolone with 1cc lidocaine 1%.
Interventions
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Us guided needling
Us guided needling is a therapeutical technique treating calcifying tendinitis of the shoulder. Calcifications in the rotator cuff tendon are visualised with ultrasound. Under ultrasound guidance a 20 gauge needle is inserted in the calcification. Lidocaine 1% in a 1cc syringe is injected in the calcification and aspirated. The calcification is flushed until the fluid is clear. Sometimes it is not possible to flush the calcification. In this case the calcification will be fragmented.
After flushing or fragmentation of the calcification, 20 mg triamcinolone with 1cc lidocaine 1% will be injected in de subacromial bursa under us guidance.
corticosteroid injection
Us guided subacromial bursa injection with 20 mg triamcinolone with 1cc lidocaine 1%.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Calcification on x-ray (Gartner type I of II) and ultrasound in the supraspinatus tendon less than 6 weeks before the treatment
* All patients are first seen and included by the orthopaedic surgeon
Exclusion Criteria
* Previous ultrasound guided needling of the shoulder
* Frozen shoulder
* Last corticosteroid injection less than 3 months ago
* Comorbidities of the painful shoulder on x-ray or ultrasound ( ruptured tendon, fracture, bursitis,...)
* No informed consent
* Pregnancy
18 Years
ALL
No
Sponsors
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Medisch Spectrum Twente
OTHER
Responsible Party
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Eva Genbrugge
Principal investigator
Principal Investigators
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Eva Genbrugge, MD
Role: PRINCIPAL_INVESTIGATOR
MST
Locations
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Medisch Spectrum Twente
Enschede, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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Eva Genbrugge, MD
Role: primary
Other Identifiers
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P12-03
Identifier Type: -
Identifier Source: org_study_id