1. Efficacy and safety of a supplement combination for hand osteoarthritis pain: protocol for an internet-based randomised placebo-controlled trial (The RADIANT study)
- Author
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Xiaoqian Liu, Sarah R Robbins, Tatyana Fedorova, Sonika Virk, David J. Hunter, Andrew J. McLachlan, Leticia A Deveza, and Jillian P Eyles
- Subjects
medicine.medical_specialty ,Curcumin ,Visual analogue scale ,Placebo-controlled study ,Placebo ,03 medical and health sciences ,0302 clinical medicine ,Quality of life (healthcare) ,Double-Blind Method ,Rheumatology ,Osteoarthritis ,medicine ,Humans ,Pain Management ,Dimethyl Sulfoxide ,Sulfones ,030212 general & internal medicine ,Adverse effect ,Randomized Controlled Trials as Topic ,030203 arthritis & rheumatology ,Protocol (science) ,Internet ,clinical trials ,business.industry ,Australia ,General Medicine ,Hand ,Symptomatic relief ,3. Good health ,Clinical trial ,Treatment Outcome ,hand & wrist ,Quality of Life ,Physical therapy ,Medicine ,Plant Preparations ,musculoskeletal disorders ,business - Abstract
IntroductionHand 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 analysisThe 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 containingBoswellia serrataextract, 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 disseminationThis 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 numberAustralian New Zealand Clinical Trials Registry (ACTRN12619000835145); Pre-results
- Published
- 2020
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