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Rotator Cuff Calcific Tendonitis: Needle US-guided treatment vs. Subacromial corticosteroids – A Randomized Controlled Trial.


- candidate number7925
- NTR NumberNTR2282
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR12-apr-2010
- Secondary IDsP09.239 METC
- Public TitleRotator Cuff Calcific Tendonitis: Needle US-guided treatment vs. Subacromial corticosteroids – A Randomized Controlled Trial.
- Scientific TitleRotator Cuff Calcific Tendonitis: Needle US-guided treatment vs. Subacromial corticosteroids – A Randomized Controlled Trial.
- ACRONYMRCCT-trial
- hypothesisWe hypothesize that US-guided treatment (barbotage) in combination with corticosteroid injections gives better short-term clinical and radiographical results, compared to treatment with solely corticosteroid injections. Secondly, we expect that patients report more complaints in the first 2 weeks after US guided treatment. After one year of follow-up, we expect to find no differences between the two groups.
- Healt Condition(s) or Problem(s) studiedRotator cuff, Calcific tendonitis
- Inclusion criteria1. Calcifying tendonitis on x-rays (< 6 weeks before eventual inclusion);
2. Age: 18-65 years;
3. Diffuse lateral shoulder pain without improvement (> 3 months);
4. Referred to orthopedics or radiology department for treatment;
5. Pain at night or after activities;
6. Worsening of complaints with elevation or abduction of the arm.
- Exclusion criteria1. Comorbidities of the affected shoulder (with physical examination, X-rays, US). Subacromial impingement syndrome is not an exclusion criterium;
2. >1 subacromial corticosteroid injections <3 months before eventual exclusion;
3. Previous barbotage treatment of the affected shoulder;
4. History of trauma or surgery on the affected shoulder;
5. Instability of the shoulder;
6. Frozen shoulder (<90 degrees of external rotation when in 90 degrees of abduction);
7. No informed consent.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 16-feb-2010
- planned closingdate16-aug-2012
- Target number of participants80
- Interventions2 Usual care methods:
1. Group A: Ultrasound-guided barbotage treatment combined with subacromial corticosteroid injection;
2. Group B: Ultrasound-guided treatment with subacromial corticosteroid injection.
- Primary outcomeConstant Shoulder Score (CS), measured at pre-intervention and at 6 weeks, 3 months, 6 months and 1 year after intervention.
- Secondary outcomePre-intervention, and at 6 weeks, 3 months, 6 months and 1 year after treatment:
1. VAS-scores for pain during motion, pain at rest and shoulder function;
2. DASH-score;
3. RAND-36;
4. Western Ontario Rotator Cuff index.

Pre-intervention:
1. Demographic data (duration of symptoms, gender, age, BMI, sports/employment);
2. Calcific depositions and location of these depositions on radiographs of the shoulder: Gärtner-classification.

Immediately after intervention:
1. VAS-scores for pain during motion, pain at rest and shoulder function;
2. Barbotage Score form: Signs of bursitis, other shoulder injuries (impingement, acromioclavicular osteoarthritis, rotator cuff ruptures), substantion of the calcific depositions (hard, pulver, viscous), aspiration (yes/no), perforation (yes/no), location of calcific depostions.

Immediately after intervention, 6 weeks, and 1 year after intervention:
1. Presence of calcific depositions on standard radiographs (anteroposterior): Gärtner score.
- TimepointsPre-intervention, post-intervention, 6 weeks, 3 months, 6 months and 1 year.
- Trial web sitehttp://www.lumc.nl/con/2020/82590/81211114221579/1002220312095711/
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD P.B. Witte, de
- CONTACT for SCIENTIFIC QUERIESMD P.B. Witte, de
- Sponsor/Initiator Leiden University Medical Center (LUMC), Rijnland Hospital
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development, Reumafonds
- PublicationsN/A
- Brief summaryCalcifying tendinitis (CAT) of the shoulder is frequently diagnosed in case of shoulder complaints. It is a self-limiting disease, but there is much discussion about whether or not to treat CaT and which treatment methods can be applied. Recently, in the “Medisch Contact” journal, it was stated that ultrasound-guided needle treatment for CaT (barbotage) is more effective than conservative treatment methods in patients diagnosed with CaT. This conclusion was based on a recent article of Serafini et al. in “Radiology”: a non-randomized trial in which patients were treated with barbotage in combination with subacromial corticosteroid injections. However, treatment and inclusion criteria of the control group were unclear. A randomized controlled trial, in which both the patient and the control group are treated with subacromial corticosteroid injections, would provide more insight in the effectiveness of barbotage-treatment in patients with CaT.

Objective of the study:
To compare short (6 weeks, 3 months) and longer term (6 months, 1 year) results of ultrasound-guided barbotage treatment combined with subacromial corticosteroid injection treatment, versus ultrasound-guided treatment with subacromial corticosteroids injection, in patients with calcific tendonitis.
- Main changes (audit trail)
- RECORD12-apr-2010 - 23-apr-2010


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