We 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…
ID
Bron
Verkorte titel
Aandoening
Rotator Cuff calcific tendonitis
Calcificerende tendinitis van de rotatoren manchet
Ondersteuning
Rijnland Hospital, Leiderdorp, the Netherlands
Reumafonds
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Constant Shoulder Score (CS), measured at pre-intervention and at 6 weeks, 3 months, 6 months and 1 year after intervention.
Achtergrond van het onderzoek
Calcifying 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.
Doel van het onderzoek
We 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.
Onderzoeksopzet
Pre-intervention, post-intervention, 6 weeks, 3 months, 6 months and 1 year.
Onderzoeksproduct en/of interventie
2 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.
Publiek
P.B. Witte, de
Albinusdreef 2, Room B-0-57
Leiden 2300 RC
The Netherlands
+31 (0)71 5263606
p.b.de_witte@lumc.nl
Wetenschappelijk
P.B. Witte, de
Albinusdreef 2, Room B-0-57
Leiden 2300 RC
The Netherlands
+31 (0)71 5263606
p.b.de_witte@lumc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. 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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. 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.
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL2158 |
| NTR-old | NTR2282 |
| Ander register | METC : P09.239 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |