Topical corticosteroid for treatment of hand osteoarthritis: study protocol for a randomised controlled trial

Yuan Z Lim,Yuanyuan Wang,Sultana Monira Hussain,Anita E Wluka,Stephane Heritier,Flavia M Cicuttini,Desmond Gan,Mahnuma Mahfuz Estee

doi:10.1186/s12891-021-04921-2

Yuan Z Lim, Yuanyuan Wang + Show 6 more

Open Access

https://doi.org/10.1186/s12891-021-04921-2

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Abstract

BackgroundHand osteoarthritis is a common and disabling chronic joint disease with a lack of effective therapies. Emerging evidence suggests the role of local inflammation in causing pain in hand osteoarthritis. Corticosteroids are potent anti-inflammatory drugs used in many rheumatic diseases. The aim of this randomised, double-blind, placebo-controlled trial is to determine whether topical corticosteroid reduces pain over 6 weeks in patients with hand osteoarthritis.MethodsOne hundred participants with hand osteoarthritis will be recruited from the community in Melbourne, Australia, and randomly allocated in a 1:1 ratio to receive either topical Diprosone OV or placebo ointment administered 3 times daily on the painful hand joints for 6 weeks. The primary outcome is pain reduction (assessed by 100 mm visual analogue scale) at 6 weeks. The secondary outcomes include changes in pain and function assessed using Functional Index for Hand Osteoarthritis, Australian Canadian Osteoarthritis Hand Index, Michigan Hand Outcomes Questionnaire, and tender and swollen joint count at 6 weeks. Adverse events will be recorded. The primary analysis will be by intention to treat, including all participants in their randomised groups.DiscussionThis study will provide high-quality evidence to determine whether topical corticosteroid reduces pain over 6 weeks in patients with hand osteoarthritis, with major clinical and public health importance by informing clinical practice guidelines for the management of hand osteoarthritis and reducing the burden of the disabling disease.Trial registrationAustralian New Zealand Clinical Trials Registry (ANZCTR), ACTRN12620000599976. Registered 22 May 2020.

Highlights

Hand osteoarthritis is a common and disabling chronic joint disease with a lack of effective therapies
We propose a randomised, double-blind, placebo-controlled trial to determine the effect of topical Diprosone OV ointment administered 3 times daily on painful hand joints compared to placebo in reducing pain and improving function in participants with hand OA over 6 weeks
Upon publication of the primary manuscript, participants will be informed of their group allocation and provided with the results. This randomised controlled trial is conducted to determine whether topical Diprosone OV ointment administered 3 times daily reduces pain over 6 weeks in participants with symptomatic hand OA

Summary

Introduction

Hand osteoarthritis is a common and disabling chronic joint disease with a lack of effective therapies. Corticosteroids are potent anti-inflammatory drugs used in many rheumatic diseases. The aim of this randomised, double-blind, placebo-controlled trial is to determine whether topical corticosteroid reduces pain over 6 weeks in patients with hand osteoarthritis. Hand osteoarthritis (OA) is a common chronic joint disease causing pain, functional disability, and decreased quality of life which result in substantial burden of disease [1, 2]. In people aged 55 years and over, 67% of the women and 54.8% of the men have radiographic OA in at least one hand joint, with 20% having disabling pain [4].

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