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. 2020 Feb 18;10(2):e035672.
doi: 10.1136/bmjopen-2019-035672.

Efficacy and Safety of a Supplement Combination for Hand Osteoarthritis Pain: Protocol for an Internet-Based Randomised Placebo-Controlled Trial (The RADIANT Study)

Free PMC article

Efficacy and Safety of a Supplement Combination for Hand Osteoarthritis Pain: Protocol for an Internet-Based Randomised Placebo-Controlled Trial (The RADIANT Study)

Xiaoqian Liu et al. BMJ Open. .
Free PMC article


Introduction: Hand osteoarthritis (HOA) is a highly prevalent disabling joint disease. The current management regimens are limited. Potentially as a consequence, many people turn to complementary and alternative medicines for symptomatic relief. A combination of two or more supplements is common in clinical practice; however, evidence for the efficacy of this approach is lacking. The aim of this study is to investigate the efficacy of a supplement combination for treating symptomatic HOA in comparison to placebo.

Methods and analysis: The RADIANT study is an internet-based, parallel, superiority, double-blind, placebo-controlled, randomised, two-arm clinical trial. A participatory design is used to facilitate the study procedures. One hundred and six participants aged over 40 years with painful HOA and structural change on X-ray (Kellgren and Lawrence grade (KLG) ≥2) will be recruited from the community and randomly allocated to receive either a supplement combination composed of: (1) combined supplement containing Boswellia serrata extract, pine bark extract and methylsulfonylmethane and (2) curcumin or placebo for 12 weeks. The primary outcome will be 12-week change in hand pain on a visual analogue scale (VAS). Main secondary outcomes include adverse events, change in hand function, patient global assessment of disease activity and quality of life. A range of additional measures will be recorded, and an individual patient placebo response will be performed. The primary analysis will be conducted using an intention-to-treat approach. Adverse events will be monitored weekly throughout the study.

Ethics and dissemination: This protocol has been approved by the University of Sydney Human Research Ethics Committee (HREC No. 2018/766). Dissemination will occur through conferences, social media, scientific publications and PhD thesis.

Trial registration number: Australian New Zealand Clinical Trials Registry (ACTRN12619000835145); Pre-results.

Keywords: clinical trials; hand & wrist; musculoskeletal disorders; rheumatology.

Conflict of interest statement

Competing interests: DJH is supported by an NHMRC Practitioner Fellowship and provides consulting advice for Merck Serono, TLC Bio, Tissuegene and Pfizer. Unity Health provides the Sydney Pharmacy School for a researcher’s salary for a project led by AM that maintains a database of herb–drug interaction. AM has served as pharmacokinetic consult to BOD Australia on a study investigating cannabidiol bioavailability (ACTRN12618000391279).


Figure 1
Figure 1
Flow diagram of the study protocol. IBJR, Institute of Bone and Joint Research.

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