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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

BACKGROUND: 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 treatm...

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Autores principales: Moosmayer, Stefan, Ekeberg, Ole Marius, Hallgren, Hanna Bjørnsson, Heier, Ingar, Kvalheim, Synnøve, Blomquist, Jesper, Pripp, Are Hugo, Juel, Nils Gunnar, Kjellevold, Stein Harald, Brox, Jens Ivar
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5379547/
https://www.ncbi.nlm.nih.gov/pubmed/28376756
http://dx.doi.org/10.1186/s12891-017-1501-9
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author Moosmayer, Stefan
Ekeberg, Ole Marius
Hallgren, Hanna Bjørnsson
Heier, Ingar
Kvalheim, Synnøve
Blomquist, Jesper
Pripp, Are Hugo
Juel, Nils Gunnar
Kjellevold, Stein Harald
Brox, Jens Ivar
author_facet Moosmayer, Stefan
Ekeberg, Ole Marius
Hallgren, Hanna Bjørnsson
Heier, Ingar
Kvalheim, Synnøve
Blomquist, Jesper
Pripp, Are Hugo
Juel, Nils Gunnar
Kjellevold, Stein Harald
Brox, Jens Ivar
author_sort Moosmayer, Stefan
collection PubMed
description BACKGROUND: 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. METHODS: 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. DISCUSSION: The scientific evidence from this placebo-controlled trial will be of importance for future treatment recommendations in patients with calcific tendinitis. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02419040, registered 10 April 2015 EudraCT: 2015-002343-34, registered 23 September 2015 (retrospectively registered) ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s12891-017-1501-9) contains supplementary material, which is available to authorized users.
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spelling pubmed-53795472017-04-07 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 Moosmayer, Stefan Ekeberg, Ole Marius Hallgren, Hanna Bjørnsson Heier, Ingar Kvalheim, Synnøve Blomquist, Jesper Pripp, Are Hugo Juel, Nils Gunnar Kjellevold, Stein Harald Brox, Jens Ivar BMC Musculoskelet Disord Study Protocol BACKGROUND: 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. METHODS: 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. DISCUSSION: The scientific evidence from this placebo-controlled trial will be of importance for future treatment recommendations in patients with calcific tendinitis. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02419040, registered 10 April 2015 EudraCT: 2015-002343-34, registered 23 September 2015 (retrospectively registered) ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s12891-017-1501-9) contains supplementary material, which is available to authorized users. BioMed Central 2017-04-04 /pmc/articles/PMC5379547/ /pubmed/28376756 http://dx.doi.org/10.1186/s12891-017-1501-9 Text en © The Author(s). 2017 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Study Protocol
Moosmayer, Stefan
Ekeberg, Ole Marius
Hallgren, Hanna Bjørnsson
Heier, Ingar
Kvalheim, Synnøve
Blomquist, Jesper
Pripp, Are Hugo
Juel, Nils Gunnar
Kjellevold, Stein Harald
Brox, Jens Ivar
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
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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5379547/
https://www.ncbi.nlm.nih.gov/pubmed/28376756
http://dx.doi.org/10.1186/s12891-017-1501-9
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