title: KALK study: ultrasound guided needling and lavage (barbotage) with steroid injection versus sham barbotage with and without steroid injection - protocol for a randomized, double-blinded, controlled, multicenter study.
abstract: For the treatment of calcific tendinitis of the shoulder a variety of treatment regimes exist. Commonly used treatment measures include medication with oral analgesics, corticosteroid injections, extracorporeal shockwave therapy, ultrasound guided needling and lavage, and surgical treatment. Earlier cohort studies suggest that patients may benefit from these treatments, but there are few randomized studies and conflicting evidence about the effectiveness of the various treatments. In the present study we aim to compare the effectiveness of ultrasound guided needling and lavage (barbotage) together with a steroid injection to sham barbotage with and without an additional steroid injection.
  
  
  
  The study will be performed in six secondary-care institutions in Norway and Sweden. It is designed as a pragmatic, randomized, three-arm, parallel group, double-blinded, sham-controlled clinical trial with a 2-year follow-up. It will be performed on 210 patients, aged 30 years or older, presenting with painful arc, positive impingement sign and a calcium deposit > 5 mm. Randomization to one of the three treatment options will be performed by using an online central randomization system. The three treatment groups are barbotage together with a subacromial steroid injection (the barbotage group), sham barbotage together with a subacromial steroid injection (the steroid group) or sham barbotage without a subacromial steroid injection (the placebo group). In the placebo group the steroid injection will be replaced by a short-acting local anaesthetic. Standardized home-based post-treatment physiotherapy will be performed by all patients for 8 weeks. Follow-ups are at 2 and 6 weeks, 4, 8, 12 and 24 months after treatment was given and will be performed with the patients and the outcome assessors blinded for group assignment. Primary outcome will be the Oxford shoulder score at 4 month follow-up. Secondary outcome measures are the QuickDASH upper extremity score, the EQ-5D-5L general health score and visual analogue scales for pain at rest, during activity, and at night.
  
  
  
  The scientific evidence from this placebo-controlled trial will be of importance for future treatment recommendations in patients with calcific tendinitis.
  
  
  
  ClinicalTrials.gov: NCT02419040 , registered 10 April 2015 EudraCT: 2015-002343-34, registered 23 September 2015 (retrospectively registered).
authors.affiliation: Orthopedic Department, Martina Hansens Hospital, Dønskiveien 8, 1346, Gjettum, Norway. st.moos@online.no.
authors.forename: Stefan
authors.identifier: 0000-0003-2518-7599
authors.initials: S
authors.lastname: Moosmayer
authors.affiliation: Department for Physical Medicine and Rehabilitation, Helse Fonna Hospital, Stord, Tysevegen 64, Stord Sjukehus HF, 5416, Stord, Norway.
authors.forename: Ole Marius
authors.initials: OM
authors.lastname: Ekeberg
authors.affiliation: Orthopedic Department, Linköping University Hospital, Garnisonsvägen 10, 581 85, Linköping, Sweden.
authors.forename: Hanna Bjørnsson
authors.initials: HB
authors.lastname: Hallgren
authors.affiliation: Department for Physical Medicine and Rehabilitation, Vestfold Hospital, Stavern, Kysthospitalveien 61, 3294, Stavern, Norway.
authors.forename: Ingar
authors.initials: I
authors.lastname: Heier
authors.affiliation: Department for Physical Medicine and Rehabilitation, Oslo University Hospital, P.O.B. 4956, Nydalen, 0424, Oslo, Norway.
authors.forename: Synnøve
authors.initials: S
authors.lastname: Kvalheim
authors.affiliation: Orthopedic Department, Haraldsplass Deaconess Hospital, P.O.B. 6165, 5892, Bergen, Norway.
authors.forename: Jesper
authors.initials: J
authors.lastname: Blomquist
authors.affiliation: Oslo Centre of Biostatistics and Epidemiology, Research Support Services, Oslo University Hospital, 0424, Oslo, Norway.
authors.forename: Are Hugo
authors.initials: AH
authors.lastname: Pripp
authors.affiliation: Department for Physical Medicine and Rehabilitation, Oslo University Hospital, P.O.B. 4956, Nydalen, 0424, Oslo, Norway.
authors.forename: Nils Gunnar
authors.initials: NG
authors.lastname: Juel
authors.affiliation: Department of Radiology, Haraldsplass Deaconess Hospital, P.O.B. 6165, 5892, Bergen, Norway.
authors.forename: Stein Harald
authors.initials: SH
authors.lastname: Kjellevold
authors.affiliation: Department for Physical Medicine and Rehabilitation, Oslo University Hospital, P.O.B. 4956, Nydalen, 0424, Oslo, Norway.
authors.forename: Jens Ivar
authors.initials: JI
authors.lastname: Brox
mesh_terms: D002114:Calcinosis / Q000150:complications / Q000628:therapy*; D004311:Double-Blind Method; D006801:Humans; D020069:Shoulder Pain / Q000209:etiology / Q000628:therapy*; D052256:Tendinopathy / Q000628:therapy*; D007507:Therapeutic Irrigation / Q000379:methods*; D018084:Ultrasonography, Interventional / Q000379:methods*
keywords: Barbotage; Calcific tendinitis; Corticosteroids; Placebo; Sham treatment; Ultrasound guided lavage