TY - JOUR
T1 - Topical corticosteroid for treatment of hand osteoarthritis
T2 - study protocol for a randomised controlled trial
AU - Wang, Yuanyuan
AU - Hussain, Sultana Monira
AU - Gan, Desmond
AU - Lim, Yuan Z.
AU - Estee, Mahnuma Mahfuz
AU - Heritier, Stephane
AU - Wluka, Anita E.
AU - Cicuttini, Flavia M.
N1 - Funding Information:
The study is funded by an Investigator Grant from the National Health and Medical Research Council of Australia (NHMRC, APP1194829), and a Project Grant from Arthritis Australia. YW is the recipient of NHMRC Translating Research into Practice Fellowship (APP1168185). SMH is the recipient of NHMRC Early Career Fellowship (APP1142198). YZL is the recipient of NHMRC Clinical Postgraduate Scholarship (APP1133903) and Royal Australasian College of Physicians Woolcock Scholarship. MME is the recipient of Bangabandhu Science and Technology Fellowship from Ministry of Science and Technology, Government of the People’s Republic of Bangladesh. AEW is the recipient of the Royal Australian College of Physicians Fellows Career Development Fellowship. FMC is the recipient of NHMRC Investigator Grant (APP1194829). The funder of the study had no role in the study design and conduct of the study; collection, management, analysis and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Publisher Copyright:
© 2021, The Author(s).
PY - 2021/12/13
Y1 - 2021/12/13
N2 - Background: Hand 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. Methods: One 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. Discussion: This 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 registration: Australian New Zealand Clinical Trials Registry (ANZCTR), ACTRN12620000599976. Registered 22 May 2020.
AB - Background: Hand 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. Methods: One 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. Discussion: This 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 registration: Australian New Zealand Clinical Trials Registry (ANZCTR), ACTRN12620000599976. Registered 22 May 2020.
KW - Function
KW - Hand
KW - Osteoarthritis
KW - Pain
KW - Topical corticosteroid
UR - http://www.scopus.com/inward/record.url?scp=85121150491&partnerID=8YFLogxK
U2 - 10.1186/s12891-021-04921-2
DO - 10.1186/s12891-021-04921-2
M3 - Article
C2 - 34903211
AN - SCOPUS:85121150491
SN - 1471-2474
VL - 22
JO - BMC Musculoskeletal Disorders
JF - BMC Musculoskeletal Disorders
IS - 1
M1 - 1036
ER -