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

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ClinicalTrials.gov Identifier: NCT01538758
Recruitment Status : Unknown
Verified July 2012 by Eva Genbrugge, Medisch Spectrum Twente.
Recruitment status was:  Recruiting
First Posted : February 24, 2012
Last Update Posted : July 12, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Calcific Tendinitis Other: Us guided needling Other: corticosteroid injection

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Study Start Date : July 2012
Estimated Primary Completion Date : July 2013
Estimated Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Steroids Ultrasound
U.S. FDA Resources

Arms and Interventions

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.

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%.


Outcome Measures

Primary Outcome Measures :
  1. VAS score on long term [ Time Frame: 1 year ]
  2. 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.


Secondary Outcome Measures :
  1. 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

  2. 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.


  3. 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.

  4. Gärtner score of the shoulder calcifications on x-ray [ Time Frame: at baseline, directly post-interventional, at 6 weeks and one year. ]
  5. 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. ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Eva Genbrugge, Principal investigator, Medisch Spectrum Twente
ClinicalTrials.gov Identifier: NCT01538758     History of Changes
Other Study ID Numbers: P12-03
First Posted: February 24, 2012    Key Record Dates
Last Update Posted: July 12, 2012
Last Verified: July 2012

Keywords provided by Eva Genbrugge, Medisch Spectrum Twente:
calcifying tendinitis
rotator cuff

Additional relevant MeSH terms:
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Tendon Injuries
Wounds and Injuries
Lidocaine
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors