Article Text

Download PDFPDF

Protocol
Efficacy and safety of a supplement combination for hand osteoarthritis pain: protocol for an internet-based randomised placebo-controlled trial (The RADIANT study)
  1. Xiaoqian Liu1,
  2. Sarah Robbins1,
  3. Jillian Eyles1,
  4. Tatyana Fedorova1,
  5. Sonika Virk1,
  6. Leticia A Deveza1,
  7. Andrew McLachlan2,
  8. David Hunter1
  1. 1Northern Clinical School, Institute of Bone and Joint Research, Kolling Institute of Medical Research, Rheumatology Department, Royal North Shore Hospital, The University of Sydney Faculty of Medicine and Health, Sydney, New South Wales, Australia
  2. 2School of Pharmacy, The University of Sydney Faculty of Medicine and Health, Sydney, New South Wales, Australia
  1. Correspondence to Professor David Hunter; david.hunter{at}sydney.edu.au

Abstract

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

  • rheumatology
  • clinical trials
  • musculoskeletal disorders
  • hand & wrist
http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

View Full Text

Statistics from Altmetric.com

Footnotes

  • Twitter @LeticiaDeveza, @ProfDavidHunter

  • Contributions DH conceived of the study. DH, XL, JE, SR, LAD, TF, SV and AM initiated the study design and XL, SR, TF and SV will facilitate the implementation. DH is the grant holder. XL will conduct the primary statistical analysis. All authors contributed to the refinement of the study protocol and approved this version. Three patients Cherie Burke, Julia Lipski and Peter Sexton contributed to the pilot study.

  • Funding The RADIANT study will be funded by an NHMRC Programme Grant (reference number: 1091302).

  • 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).

  • Patient consent for publication Not required.

  • Ethics approval Ethical approval has been obtained from The University of Sydney Human Research Ethics Committee (HREC No 2018/766).

  • Provenance and peer review Not commissioned; externally peer reviewed.

Request Permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.