METHODS - A randomised controlled trial of METhotrexate to treat Hand Osteoarthritis with Synovitis: study protocol for a randomised controlled trial

Abstract Background Hand osteoarthritis is a common and disabling problem without effective therapies. Accumulating evidence suggests the role of local inflammation in causing pain and structural progression in hand osteoarthritis, and hand osteoarthritis with synovitis is a commonly encountered cli...

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Autores principales:	Yuanyuan Wang, Andrew J. Teichtahl, Graeme Jones, Helen I. Keen, Catherine L. Hill, Anita E. Wluka, Jessica Kasza, Flavia M. Cicuttini
Formato:	article
Lenguaje:	EN
Publicado:	BMC 2021
Materias:	Methotrexate Osteoarthritis Hand Pain Function Diseases of the musculoskeletal system RC925-935
Acceso en línea:	https://doaj.org/article/acea74d1b50448f286de7ee43ed13544
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spelling	oai:doaj.org-article:acea74d1b50448f286de7ee43ed135442021-11-21T12:27:49ZMETHODS - A randomised controlled trial of METhotrexate to treat Hand Osteoarthritis with Synovitis: study protocol for a randomised controlled trial10.1186/s12891-021-04842-01471-2474https://doaj.org/article/acea74d1b50448f286de7ee43ed135442021-11-01T00:00:00Zhttps://doi.org/10.1186/s12891-021-04842-0https://doaj.org/toc/1471-2474Abstract Background Hand osteoarthritis is a common and disabling problem without effective therapies. Accumulating evidence suggests the role of local inflammation in causing pain and structural progression in hand osteoarthritis, and hand osteoarthritis with synovitis is a commonly encountered clinical phenotype. Methotrexate is a well-established, low-cost, and effective treatment for inflammatory arthritis with a well-described safety profile. The aim of this multicentre, randomised, double-blind, placebo-controlled trial is to determine whether methotrexate reduces pain over 6 months in patients with hand osteoarthritis and synovitis. Methods Ninety-six participants with hand osteoarthritis and synovitis will be recruited through the Osteoarthritis Clinical Trial Network (Melbourne, Hobart, Adelaide, and Perth), and randomly allocated in a 1:1 ratio to receive either methotrexate 20 mg or identical placebo once weekly for 6 months. The primary outcome is pain reduction (assessed by 100 mm visual analogue scale) at 6 months. The secondary outcomes include changes in physical function and quality of life assessed using Functional Index for Hand Osteoarthritis, Australian Canadian Osteoarthritis Hand Index, Health Assessment Questionnaire, Michigan Hand Outcomes Questionnaire, Short-Form-36, tender and swollen joint count, and grip strength, and structural progression assessed using progression of synovitis and bone marrow lesions from magnetic resonance imaging and radiographic progression at 6 months. Adverse events will be recorded. The primary analysis will be by intention to treat, including all participants in their randomised groups. Discussion This study will provide high-quality evidence to address whether methotrexate has an effect on reducing pain over 6 months in patients with hand osteoarthritis and synovitis, with major clinical and public health importance. While a positive trial will inform international clinical practice guidelines for the management of hand osteoarthritis, a negative trial would be highly topical and change current trends in clinical practice. Trial registration Australian New Zealand Clinical Trials Registry (ANZCTR), ACTRN12617000877381. Registered 15 June 2017, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=373124Yuanyuan WangAndrew J. TeichtahlGraeme JonesHelen I. KeenCatherine L. HillAnita E. WlukaJessica KaszaFlavia M. CicuttiniBMCarticleMethotrexateOsteoarthritisHandPainFunctionDiseases of the musculoskeletal systemRC925-935ENBMC Musculoskeletal Disorders, Vol 22, Iss 1, Pp 1-11 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Methotrexate Osteoarthritis Hand Pain Function Diseases of the musculoskeletal system RC925-935
spellingShingle	Methotrexate Osteoarthritis Hand Pain Function Diseases of the musculoskeletal system RC925-935 Yuanyuan Wang Andrew J. Teichtahl Graeme Jones Helen I. Keen Catherine L. Hill Anita E. Wluka Jessica Kasza Flavia M. Cicuttini METHODS - A randomised controlled trial of METhotrexate to treat Hand Osteoarthritis with Synovitis: study protocol for a randomised controlled trial
description	Abstract Background Hand osteoarthritis is a common and disabling problem without effective therapies. Accumulating evidence suggests the role of local inflammation in causing pain and structural progression in hand osteoarthritis, and hand osteoarthritis with synovitis is a commonly encountered clinical phenotype. Methotrexate is a well-established, low-cost, and effective treatment for inflammatory arthritis with a well-described safety profile. The aim of this multicentre, randomised, double-blind, placebo-controlled trial is to determine whether methotrexate reduces pain over 6 months in patients with hand osteoarthritis and synovitis. Methods Ninety-six participants with hand osteoarthritis and synovitis will be recruited through the Osteoarthritis Clinical Trial Network (Melbourne, Hobart, Adelaide, and Perth), and randomly allocated in a 1:1 ratio to receive either methotrexate 20 mg or identical placebo once weekly for 6 months. The primary outcome is pain reduction (assessed by 100 mm visual analogue scale) at 6 months. The secondary outcomes include changes in physical function and quality of life assessed using Functional Index for Hand Osteoarthritis, Australian Canadian Osteoarthritis Hand Index, Health Assessment Questionnaire, Michigan Hand Outcomes Questionnaire, Short-Form-36, tender and swollen joint count, and grip strength, and structural progression assessed using progression of synovitis and bone marrow lesions from magnetic resonance imaging and radiographic progression at 6 months. Adverse events will be recorded. The primary analysis will be by intention to treat, including all participants in their randomised groups. Discussion This study will provide high-quality evidence to address whether methotrexate has an effect on reducing pain over 6 months in patients with hand osteoarthritis and synovitis, with major clinical and public health importance. While a positive trial will inform international clinical practice guidelines for the management of hand osteoarthritis, a negative trial would be highly topical and change current trends in clinical practice. Trial registration Australian New Zealand Clinical Trials Registry (ANZCTR), ACTRN12617000877381. Registered 15 June 2017, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=373124
format	article
author	Yuanyuan Wang Andrew J. Teichtahl Graeme Jones Helen I. Keen Catherine L. Hill Anita E. Wluka Jessica Kasza Flavia M. Cicuttini
author_facet	Yuanyuan Wang Andrew J. Teichtahl Graeme Jones Helen I. Keen Catherine L. Hill Anita E. Wluka Jessica Kasza Flavia M. Cicuttini
author_sort	Yuanyuan Wang
title	METHODS - A randomised controlled trial of METhotrexate to treat Hand Osteoarthritis with Synovitis: study protocol for a randomised controlled trial
title_short	METHODS - A randomised controlled trial of METhotrexate to treat Hand Osteoarthritis with Synovitis: study protocol for a randomised controlled trial
title_full	METHODS - A randomised controlled trial of METhotrexate to treat Hand Osteoarthritis with Synovitis: study protocol for a randomised controlled trial
title_fullStr	METHODS - A randomised controlled trial of METhotrexate to treat Hand Osteoarthritis with Synovitis: study protocol for a randomised controlled trial
title_full_unstemmed	METHODS - A randomised controlled trial of METhotrexate to treat Hand Osteoarthritis with Synovitis: study protocol for a randomised controlled trial
title_sort	methods - a randomised controlled trial of methotrexate to treat hand osteoarthritis with synovitis: study protocol for a randomised controlled trial
publisher	BMC
publishDate	2021
url	https://doaj.org/article/acea74d1b50448f286de7ee43ed13544
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METHODS - A randomised controlled trial of METhotrexate to treat Hand Osteoarthritis with Synovitis: study protocol for a randomised controlled trial

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