Rotator Cuff Calcific Tendonitis

Het onderzoek

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

Project leaders

PhD students

Pieter Bas de Witte, MD, BSc

Advisors

  • Prof. J.L. Bloem, MD, PhD
  • A. Navas Canete, MD

Technology

  • Ultrasound treatment
  • Clinical scores

Start/End Date

01/09/2009– 01/09/2012

Grant giver

  • Dutch Arthritis Association (in dutch: Reumafonds)
  • ZonMw-Agiko

Academic partners

  • Department of Orthopedics, Rijnland Hospital, Leiderdorp
  • Department of Rehabilitation, LUMC, Leiden
  • Department of Radiology, LUMC, Leiden

Abstract

Rationale: Calcific 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 Dutch “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: 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.

Study design: Multicenter randomized controlled trial, double blinded

Study population: Patients diagnosed with CaT, referred for treatment of CaT, 18-65 years old. 

Intervention:

2 Usual care methods:
Group A: ultrasound-guided barbotage treatment combined with subacromial corticosteroid injection.
Group B: ultrasound-guided treatment with subacromial corticosteroid injection. 

Main outcome parameters:  All outcome parameters will be obtained before the intervention procedure, and at several moments in follow-up after the intervention.

Primary study parameters: Constant Shoulder Score

Secondary study parameters:

  • Demographic data
  • Barbotage Ultrasound parameters: signs of bursitis, other shoulder injuries, substance of the calcific depositions, aspiration (yes/no), perforation (yes/no), location of calcific depositions
  • Presence of calcific depositions on standard radiographs: Gärtner score
  • Clinical scores: VAS-scores for pain during motion, pain at rest and shoulder function, DASH-score, RAND-36, Western Ontario Rotator Cuff index

References

Serafini, G., Sconfienza, L. M., Lacelli, F., Silvestri, E., Aliprandi, A., and Sardanelli, F.: Rotator cuff calcific tendonitis: short-term and 10-year outcomes after two-needle us-guided percutaneous treatment--nonrandomized controlled trial. Radiology. 252:157-164, 2009