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.

Ultrasound Guided Needling Versus Ultrasound Guided Corticosteroid Injection Alone, a Randomized Controlled Trial.

Sponsors

Lead sponsor: Medisch Spectrum Twente

Source Medisch Spectrum Twente
Brief Summary

Ultrasound guided needling is becoming an accepted treatment for patients with shoulder pain due to calcifying tendinitis. However, evidence for this treatment is lacking. The investigators expect that patients treated with us guided needling with corticosteroid injection compared with patients treated with only corticosteroid injections in the subacromial bursa have better clinical outcome after one year follow-up.

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.

Overall Status Unknown status
Start Date July 2012
Completion Date July 2014
Primary Completion Date July 2013
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
VAS score on long term 1 year
Constant score on long term 1 year
Secondary Outcome
Measure Time Frame
Constant score baseline,6 weeks, 3 months and 6 months
VAS score Baseline, 2 weeks, 6 weeks, 3 months and 6 months
DASH score baseline, 6 weeks, 3 months, 6 months and 1 year.
Gärtner score of the shoulder calcifications on x-ray at baseline, directly post-interventional, at 6 weeks and one year.
Scoring system presented by Chiou et all. of the calcifications of the supraspinatus tendon on ultrasound at baseline, directly post-interventional, at 6 weeks and one year.
Enrollment 80
Condition
Intervention

Intervention type: Other

Intervention name: Us guided needling

Description: 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.

Arm group label: Us guided needling

Other name: Barbotage

Intervention type: Other

Intervention name: corticosteroid injection

Description: Us guided subacromial bursa injection with 20 mg triamcinolone with 1cc lidocaine 1%.

Arm group label: corticosteroid injection

Eligibility

Criteria:

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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Eva Genbrugge, MD Principal Investigator MST
Overall Contact

Last name: Eva Genbrugge, MD

Phone: +31 53 4 87 20 00

Email: [email protected]

Location
facility status contact investigator
Medisch Spectrum Twente Recruiting Eva Genbrugge, MD +31 534872000 [email protected] Eva Genbrugge, MD Principal Investigator
Location Countries

Netherlands

Verification Date

July 2012

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Medisch Spectrum Twente

Investigator full name: Eva Genbrugge

Investigator title: Principal investigator

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Us guided needling

Arm group type: Active Comparator

Description: 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.

Arm group label: corticosteroid injection

Arm group type: Active Comparator

Description: Us guided subacromial bursa injection with 20 mg triamcinolone with 1cc lidocaine 1%.

Acronym BARB-01
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov