Ultrasound Guided Needling Versus Ultrasound Guided Corticosteroid Injection Alone, a Randomized Controlled Trial. (BARB-01)

July 11, 2012 updated by: Eva Genbrugge, Medisch Spectrum Twente

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 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.

Study Overview

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

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Enschede, Netherlands, 7513 ER
        • Recruiting
        • Medisch Spectrum Twente
        • Contact:
        • Principal Investigator:
          • Eva Genbrugge, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:
  • Barbotage
Active Comparator: corticosteroid injection
Us guided subacromial bursa injection with 20 mg triamcinolone with 1cc lidocaine 1%.
Us guided subacromial bursa injection with 20 mg triamcinolone with 1cc lidocaine 1%.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VAS score on long term
Time Frame: 1 year
1 year
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.
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
baseline,6 weeks, 3 months and 6 months
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
DASH score
Time Frame: baseline, 6 weeks, 3 months, 6 months and 1 year.
This score measures the disability of the shoulder in daily life, work, sports and hobby over time.
baseline, 6 weeks, 3 months, 6 months and 1 year.
Gärtner score of the shoulder calcifications on x-ray
Time Frame: at baseline, directly post-interventional, at 6 weeks and one year.
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
Time Frame: at baseline, directly post-interventional, at 6 weeks and one year.
at baseline, directly post-interventional, at 6 weeks and one year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Eva Genbrugge, MD, MST

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Anticipated)

July 1, 2013

Study Completion (Anticipated)

July 1, 2014

Study Registration Dates

First Submitted

November 30, 2011

First Submitted That Met QC Criteria

February 18, 2012

First Posted (Estimate)

February 24, 2012

Study Record Updates

Last Update Posted (Estimate)

July 12, 2012

Last Update Submitted That Met QC Criteria

July 11, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

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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