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

Primary Purpose

Calcific Tendinitis

Status
Unknown status
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Us guided needling
corticosteroid injection
Sponsored by
Medisch Spectrum Twente
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Calcific Tendinitis focused on measuring calcifying tendinitis, rotator cuff

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medisch Spectrum TwenteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Us guided needling

corticosteroid injection

Arm 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.

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

Outcomes

Primary Outcome Measures

VAS score on long term
Constant score on long term
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
To have a more insight over time the constant score will be measured at baseline, 6 weeks, 3 months and 6 months
VAS score
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
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
Scoring system presented by Chiou et all. of the calcifications of the supraspinatus tendon on ultrasound

Full Information

First Posted
November 30, 2011
Last Updated
July 11, 2012
Sponsor
Medisch Spectrum Twente
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1. Study Identification

Unique Protocol Identification Number
NCT01538758
Brief Title
Ultrasound Guided Needling Versus Ultrasound Guided Corticosteroid Injection Alone, a Randomized Controlled Trial.
Acronym
BARB-01
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 Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Unknown status
Study Start Date
July 2012 (undefined)
Primary Completion Date
July 2013 (Anticipated)
Study Completion Date
July 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medisch Spectrum Twente

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Calcific Tendinitis
Keywords
calcifying tendinitis, rotator cuff

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Us guided needling
Arm Type
Active Comparator
Arm 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 Title
corticosteroid injection
Arm Type
Active Comparator
Arm Description
Us guided subacromial bursa injection with 20 mg triamcinolone with 1cc lidocaine 1%.
Intervention Type
Other
Intervention Name(s)
Us guided needling
Other Intervention Name(s)
Barbotage
Intervention 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.
Intervention Type
Other
Intervention Name(s)
corticosteroid injection
Intervention Description
Us guided subacromial bursa injection with 20 mg triamcinolone with 1cc lidocaine 1%.
Primary Outcome Measure Information:
Title
VAS score on long term
Time Frame
1 year
Title
Constant score on long term
Description
The constant score is a validated scale, measuring the shoulder function. It is a objective measurement independent of the shoulder pain.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Constant score
Description
To have a more insight over time the constant score will be measured at baseline, 6 weeks, 3 months and 6 months
Time Frame
baseline,6 weeks, 3 months and 6 months
Title
VAS score
Description
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.
Time Frame
Baseline, 2 weeks, 6 weeks, 3 months and 6 months
Title
DASH score
Description
This score measures the disability of the shoulder in daily life, work, sports and hobby over time.
Time Frame
baseline, 6 weeks, 3 months, 6 months and 1 year.
Title
Gärtner score of the shoulder calcifications on x-ray
Time Frame
at baseline, directly post-interventional, at 6 weeks and one year.
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eva Genbrugge, MD
Phone
+31 53 4 87 20 00
Email
eva_genbrugge@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eva Genbrugge, MD
Organizational Affiliation
MST
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medisch Spectrum Twente
City
Enschede
ZIP/Postal Code
7513 ER
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eva Genbrugge, MD
Phone
+31 534872000
Email
eva_genbrugge@hotmail.com
First Name & Middle Initial & Last Name & Degree
Eva Genbrugge, MD

12. IPD Sharing Statement

Learn more about this trial

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

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