- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01538758
Ultrasound Guided Needling Versus Ultrasound Guided Corticosteroid Injection Alone, a Randomized Controlled Trial. (BARB-01)
Treatment of Calcifying Tendinitis of the Shoulder: Ultrasound Guided Needling With Subacromial Corticosteroid Injection Versus Ultrasound Guided Subacromial Corticosteroid Injection Only, a Randomized Controlled Trial.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Calcifying tendinitis of the shoulder is a common cause of shoulder pain with an incidence ranging from 2.7 % to 6.8 %. This disease of the rotator cuff tendons is characterised by calcifications in the tendons, most commonly in the supraspinatus tendon up to 82%. The aetiology remains unclear.
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Eva Genbrugge, MD
- Phone Number: +31 53 4 87 20 00
- Email: eva_genbrugge@hotmail.com
Study Locations
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Enschede, Netherlands, 7513 ER
- Recruiting
- Medisch Spectrum Twente
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Contact:
- Eva Genbrugge, MD
- Phone Number: +31 534872000
- Email: eva_genbrugge@hotmail.com
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Principal Investigator:
- Eva Genbrugge, MD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Shoulder pain without improvement after 3 months despite conservative treatment
- 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 operation of the shoulder
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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 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.
Other Names:
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Active Comparator: corticosteroid injection
Us guided subacromial bursa injection with 20 mg triamcinolone with 1cc lidocaine 1%.
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Us guided subacromial bursa injection with 20 mg triamcinolone with 1cc lidocaine 1%.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
VAS score on long term
Time Frame: 1 year
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1 year
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Constant score on long term
Time Frame: 1 year
|
The constant score is a validated scale, measuring the shoulder function.
It is a objective measurement independent of the shoulder pain.
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1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Constant score
Time Frame: baseline,6 weeks, 3 months and 6 months
|
To have a more insight over time the constant score will be measured at baseline, 6 weeks, 3 months and 6 months
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baseline,6 weeks, 3 months and 6 months
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VAS score
Time Frame: Baseline, 2 weeks, 6 weeks, 3 months and 6 months
|
To have a more insight over time the VAS score will be measured at baseline, 6 weeks, 3 months and 6 months. In practice patients seem to have a maximum pain shortly after the us guided needling. To measure this a VAS score will be taken after two weeks. |
Baseline, 2 weeks, 6 weeks, 3 months and 6 months
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DASH score
Time Frame: baseline, 6 weeks, 3 months, 6 months and 1 year.
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This score measures the disability of the shoulder in daily life, work, sports and hobby over time.
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baseline, 6 weeks, 3 months, 6 months and 1 year.
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Gärtner score of the shoulder calcifications on x-ray
Time Frame: at baseline, directly post-interventional, at 6 weeks and one year.
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at baseline, directly post-interventional, at 6 weeks and one year.
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Scoring system presented by Chiou et all. of the calcifications of the supraspinatus tendon on ultrasound
Time Frame: at baseline, directly post-interventional, at 6 weeks and one year.
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at baseline, directly post-interventional, at 6 weeks and one year.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Eva Genbrugge, MD, MST
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P12-03
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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