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

This study is currently recruiting participants.
Verified July 2012 by Medisch Spectrum Twente
Sponsor:
Information provided by (Responsible Party):
Eva Genbrugge, Medisch Spectrum Twente
ClinicalTrials.gov Identifier:
NCT01538758
First received: November 30, 2011
Last updated: July 11, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention
Calcific Tendinitis
Other: Us guided needling
Other: corticosteroid injection

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Medisch Spectrum Twente:

Primary Outcome Measures:
  • VAS score on long term [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Constant score on long term [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The constant score is a validated scale, measuring the shoulder function. It is a objective measurement independent of the shoulder pain.


Secondary Outcome Measures:
  • Constant score [ Time Frame: baseline,6 weeks, 3 months and 6 months ] [ Designated as safety issue: No ]
    To have a more insight over time the constant score will be measured at baseline, 6 weeks, 3 months and 6 months

  • VAS score [ Time Frame: Baseline, 2 weeks, 6 weeks, 3 months and 6 months ] [ Designated as safety issue: No ]

    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.


  • DASH score [ Time Frame: baseline, 6 weeks, 3 months, 6 months and 1 year. ] [ Designated as safety issue: No ]
    This score measures the disability of the shoulder in daily life, work, sports and hobby over time.

  • Gärtner score of the shoulder calcifications on x-ray [ Time Frame: at baseline, directly post-interventional, at 6 weeks and one year. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: July 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Other: 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.

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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01538758

Contacts
Contact: Eva Genbrugge, MD +31 53 4 87 20 00 eva_genbrugge@hotmail.com

Locations
Netherlands
Medisch Spectrum Twente Recruiting
Enschede, Netherlands, 7513 ER
Contact: Eva Genbrugge, MD    +31 534872000    eva_genbrugge@hotmail.com   
Principal Investigator: Eva Genbrugge, MD         
Sponsors and Collaborators
Medisch Spectrum Twente
Investigators
Principal Investigator: Eva Genbrugge, MD MST
  More Information

No publications provided

Responsible Party: Eva Genbrugge, Principal investigator, Medisch Spectrum Twente
ClinicalTrials.gov Identifier: NCT01538758     History of Changes
Other Study ID Numbers: P12-03
Study First Received: November 30, 2011
Last Updated: July 11, 2012
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Medisch Spectrum Twente:
calcifying tendinitis
rotator cuff

Additional relevant MeSH terms:
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Tendon Injuries
Wounds and Injuries
Triamcinolone
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 16, 2014