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Clinical and cost effectiveness of a corticosteroid injection versus exercise therapy for shoulder pain in general practice: protocol for a randomised controlled trial (SIX Study)

INTRODUCTION: Shoulder pain is common and the prognosis is often unfavourable. Dutch guidelines on the treatment of shoulder pain in primary care recommend a corticosteroid injection or a referral to exercise therapy, if initial pain management fails and pain persists. However, evidence of the effec...

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Autores principales: van Doorn, Pieter F, de Schepper, Evelien I T, Schiphof, Dieuwke, Ottenheijm, Ramon P G, Thoomes-de Graaf, Marloes, Koopmanschap, Marc A, van Ochten, John M, van der Windt, Danielle A, Bindels, Patrick J E, Koes, Bart W, Runhaar, Jos
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8011792/
https://www.ncbi.nlm.nih.gov/pubmed/33785496
http://dx.doi.org/10.1136/bmjopen-2021-050101
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author van Doorn, Pieter F
de Schepper, Evelien I T
Schiphof, Dieuwke
Ottenheijm, Ramon P G
Thoomes-de Graaf, Marloes
Koopmanschap, Marc A
van Ochten, John M
van der Windt, Danielle A
Bindels, Patrick J E
Koes, Bart W
Runhaar, Jos
author_facet van Doorn, Pieter F
de Schepper, Evelien I T
Schiphof, Dieuwke
Ottenheijm, Ramon P G
Thoomes-de Graaf, Marloes
Koopmanschap, Marc A
van Ochten, John M
van der Windt, Danielle A
Bindels, Patrick J E
Koes, Bart W
Runhaar, Jos
author_sort van Doorn, Pieter F
collection PubMed
description INTRODUCTION: Shoulder pain is common and the prognosis is often unfavourable. Dutch guidelines on the treatment of shoulder pain in primary care recommend a corticosteroid injection or a referral to exercise therapy, if initial pain management fails and pain persists. However, evidence of the effectiveness of a corticosteroid injection compared with exercise therapy, especially in the long term, is limited. This trial will assess the clinical effectiveness and cost effectiveness of a corticosteroid injection compared with physiotherapist-led exercise therapy over 12 months follow-up in patients with shoulder pain in primary care. METHODS AND ANALYSIS: The SIX Study is a multicentre, pragmatic randomised clinical trial in primary care. A total of 213 patients with shoulder pain, aged ≥18 years presenting in general practice will be included. Patients will be randomised (1:1) into two groups: a corticosteroid injection or 12 sessions of physiotherapist-led exercise therapy. The effect of the allocated treatment will be assessed through questionnaires at 6 weeks and after 3, 6, 9 and 12 months. The primary outcome is patient’s reported shoulder pain-intensity and function, measured with the Shoulder Pain and Disability Index, over 12 months follow-up. Secondary outcomes include cost effectiveness, pain-intensity, function, health-related quality of life, sleep quality, patient’s global perceived effect, work absence, healthcare utilisation and adverse events. Between group differences will be evaluated using a repeated measurements analysis with linear effects models. A cost-utility analysis will be performed to assess the cost effectiveness using quality-adjusted life years from a medical and societal perspective. ETHICS AND DISSEMINATION: This study was approved by the Medical Ethics Committee of Erasmus MC University Medical Center Rotterdam (MEC 2020-0300). All participants will give written informed consent prior to data collection. The results from this study will be disseminated in international journals and implemented in the primary care guidelines on shoulder pain. TRIAL REGISTRATION NUMBER: Dutch Trial Registry (NL8854).
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spelling pubmed-80117922021-04-16 Clinical and cost effectiveness of a corticosteroid injection versus exercise therapy for shoulder pain in general practice: protocol for a randomised controlled trial (SIX Study) van Doorn, Pieter F de Schepper, Evelien I T Schiphof, Dieuwke Ottenheijm, Ramon P G Thoomes-de Graaf, Marloes Koopmanschap, Marc A van Ochten, John M van der Windt, Danielle A Bindels, Patrick J E Koes, Bart W Runhaar, Jos BMJ Open General practice / Family practice INTRODUCTION: Shoulder pain is common and the prognosis is often unfavourable. Dutch guidelines on the treatment of shoulder pain in primary care recommend a corticosteroid injection or a referral to exercise therapy, if initial pain management fails and pain persists. However, evidence of the effectiveness of a corticosteroid injection compared with exercise therapy, especially in the long term, is limited. This trial will assess the clinical effectiveness and cost effectiveness of a corticosteroid injection compared with physiotherapist-led exercise therapy over 12 months follow-up in patients with shoulder pain in primary care. METHODS AND ANALYSIS: The SIX Study is a multicentre, pragmatic randomised clinical trial in primary care. A total of 213 patients with shoulder pain, aged ≥18 years presenting in general practice will be included. Patients will be randomised (1:1) into two groups: a corticosteroid injection or 12 sessions of physiotherapist-led exercise therapy. The effect of the allocated treatment will be assessed through questionnaires at 6 weeks and after 3, 6, 9 and 12 months. The primary outcome is patient’s reported shoulder pain-intensity and function, measured with the Shoulder Pain and Disability Index, over 12 months follow-up. Secondary outcomes include cost effectiveness, pain-intensity, function, health-related quality of life, sleep quality, patient’s global perceived effect, work absence, healthcare utilisation and adverse events. Between group differences will be evaluated using a repeated measurements analysis with linear effects models. A cost-utility analysis will be performed to assess the cost effectiveness using quality-adjusted life years from a medical and societal perspective. ETHICS AND DISSEMINATION: This study was approved by the Medical Ethics Committee of Erasmus MC University Medical Center Rotterdam (MEC 2020-0300). All participants will give written informed consent prior to data collection. The results from this study will be disseminated in international journals and implemented in the primary care guidelines on shoulder pain. TRIAL REGISTRATION NUMBER: Dutch Trial Registry (NL8854). BMJ Publishing Group 2021-03-30 /pmc/articles/PMC8011792/ /pubmed/33785496 http://dx.doi.org/10.1136/bmjopen-2021-050101 Text en © Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ. https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.
spellingShingle General practice / Family practice
van Doorn, Pieter F
de Schepper, Evelien I T
Schiphof, Dieuwke
Ottenheijm, Ramon P G
Thoomes-de Graaf, Marloes
Koopmanschap, Marc A
van Ochten, John M
van der Windt, Danielle A
Bindels, Patrick J E
Koes, Bart W
Runhaar, Jos
Clinical and cost effectiveness of a corticosteroid injection versus exercise therapy for shoulder pain in general practice: protocol for a randomised controlled trial (SIX Study)
title Clinical and cost effectiveness of a corticosteroid injection versus exercise therapy for shoulder pain in general practice: protocol for a randomised controlled trial (SIX Study)
title_full Clinical and cost effectiveness of a corticosteroid injection versus exercise therapy for shoulder pain in general practice: protocol for a randomised controlled trial (SIX Study)
title_fullStr Clinical and cost effectiveness of a corticosteroid injection versus exercise therapy for shoulder pain in general practice: protocol for a randomised controlled trial (SIX Study)
title_full_unstemmed Clinical and cost effectiveness of a corticosteroid injection versus exercise therapy for shoulder pain in general practice: protocol for a randomised controlled trial (SIX Study)
title_short Clinical and cost effectiveness of a corticosteroid injection versus exercise therapy for shoulder pain in general practice: protocol for a randomised controlled trial (SIX Study)
title_sort clinical and cost effectiveness of a corticosteroid injection versus exercise therapy for shoulder pain in general practice: protocol for a randomised controlled trial (six study)
topic General practice / Family practice
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8011792/
https://www.ncbi.nlm.nih.gov/pubmed/33785496
http://dx.doi.org/10.1136/bmjopen-2021-050101
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