Calcific TendinitisBARB-01NCT01538758
Ultrasound Guided Needling Versus Ultrasound Guided Corticosteroid Injection Alone, a Randomized Controlled Trial.
A study testing Us guided needling and corticosteroid injection in people with Calcific Tendinitis, run by Medisch Spectrum Twente at 1 site in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Calcific Tendinitis
- What is being tested?
- Us guided needling and corticosteroid injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteNetherlands
- Study dates
- Jul 2012to Jul 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Medisch Spectrum Twente
Enschede, 7513 ER
Eva Genbrugge, MD, +31 534872000, eva_genbrugge@hotmail.com
Eva Genbrugge, MD
About this study
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.
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.
Read the 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.
- Conditions
- Calcific Tendinitis
- Being tested
- Us guided needling, corticosteroid injection
- Keywords
- calcifying tendinitis, rotator cuff
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Us guided needlingOther
Also called Barbotage
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.
corticosteroid injectionOther
Us guided subacromial bursa injection with 20 mg triamcinolone with 1cc lidocaine 1%.
| Study group | Role | What they receive |
|---|---|---|
| Us guided needling | Active comparator | 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. Receives: Other: Us guided needling |
| corticosteroid injection | Active comparator | Us guided subacromial bursa injection with 20 mg triamcinolone with 1cc lidocaine 1%. Receives: Other: corticosteroid injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS score on long term
Measured: 1 year
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.
Measured: 1 year
Secondary outcomes (5)
Constant score
To have a more insight over time the constant score will be measured at baseline, 6 weeks, 3 months and 6 months
Measured: 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.
Measured: Baseline, 2 weeks, 6 weeks, 3 months and 6 months
DASH score
This score measures the disability of the shoulder in daily life, work, sports and hobby over time.
Measured: baseline, 6 weeks, 3 months, 6 months and 1 year.
Gärtner score of the shoulder calcifications on x-ray
Measured: 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
Measured: at baseline, directly post-interventional, at 6 weeks and one year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2012 (estimated)
- Study startJul 2012
- Primary completionJul 2013 (estimated)
- Study completionJul 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Calcific TendinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medisch Spectrum Twente
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eva Genbrugge, Medisch Spectrum Twente
- Investigators
- Eva Genbrugge, MD, Principal investigator, MST
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01538758
- Sponsor's protocol ID
- P12-03
- Acronym
- BARB-01
- Status last verified
- Jul 2012
- First submitted
- 30 Nov 2011
- Last updated
- 12 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01538758
- Acronym / sponsor ID
- BARB-01 / P12-03
- Conditions
- Calcific Tendinitis
- Keywords
- calcifying tendinitis, rotator cuff
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Medisch Spectrum TwenteUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Jul 2013 (estimated)
- Study completion
- Jul 2014 (estimated)
- First posted
- 24 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Us guided needling | Active comparator | Other: Us guided needlingUs 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. |
| corticosteroid injection | Active comparator | Other: corticosteroid injectionUs guided subacromial bursa injection with 20 mg triamcinolone with 1cc lidocaine 1%. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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,...)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Us guided needlingAlso: BarbotageUs 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 |
| corticosteroid injectionUs guided subacromial bursa injection with 20 mg triamcinolone with 1cc lidocaine 1%. | Other | corticosteroid injection |
Primary outcome
VAS score on long term
Time frame: 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.
5 secondary outcomes
Constant score
Time frame: baseline,6 weeks, 3 months and 6 months
VAS score
Time frame: Baseline, 2 weeks, 6 weeks, 3 months and 6 months
DASH score
Time frame: 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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eva Genbrugge, MD principal investigator
MST
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Us guided needling and corticosteroid injection in people with Calcific Tendinitis, run by Medisch Spectrum Twente at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eva Genbrugge, MD (+31 53 4 87 20 00, eva_genbrugge@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS score on long term (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2012.