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  • Efficacy of combined conservative therapies on clinical outcomes in patients with thumb base osteoarthritis: protocol for a randomised, controlled trial (COMBO)

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Rheumatology
Protocol
Efficacy of combined conservative therapies on clinical outcomes in patients with thumb base osteoarthritis: protocol for a randomised, controlled trial (COMBO)
  1. Leticia A Deveza1,
  2. David J Hunter1,
  3. Anne Wajon2,
  4. Kim L Bennell3,
  5. Bill Vicenzino4,
  6. Paul Hodges4,
  7. Jillian P Eyles1,
  8. Ray Jongs5,
  9. Edward A Riordan1,
  10. Vicky Duong1,
  11. Win Min Oo1,
  12. Rachel O'Connell6,
  13. Sarah R F Meneses1
  1. 1Rheumatology Department, Royal North Shore Hospital and Institute of Bone and Joint Research, Kolling Institute, University of Sydney, Sydney, New South Wales, Australia
  2. 2Macquarie University Clinic, Macquarie Hand Therapy, Macquarie University, New South Wales, Australia
  3. 3Department of Physiotherapy, Centre for Health, Exercise and Sports Medicine, School of Health Sciences, The University of Melbourne, Melbourne, Victoria, Australia
  4. 4School of Health and Rehabilitation Sciences: Physiotherapy, The University of Queensland, Brisbane, St. Lucia, Australia
  5. 5Physiotherapy Department, Royal North Shore Hospital, Sydney, New South Wales, Australia
  6. 6National Health and Medical Research Council (NHMRC) Clinical Trial Centre, University of Sydney, Sydney, New South Wales, Australia
  1. Correspondence to Dr Leticia A Deveza; leticia.alle{at}sydney.edu.au

Abstract

Introduction Management of thumb base osteoarthritis (OA) using a combination of therapies is common in clinical practice; however, evidence for the efficacy of this approach is lacking. The aim of this study is to determine the effect of a combination of conservative therapies for the treatment of thumb base OA compared with an education control group.

Methods and analysis This is a randomised, controlled, single-centre, two-arm superiority trial with 1:1 allocation ratio; with assessor and statistician blinded. Participants are blinded to the trial's hypothesis and to the interventions received by the opposite group. A total of 204 participants will be recruited from the community and randomised using a computer-generated schedule. The intervention group will receive education for joint protection and OA, a splint for the base of the thumb, hand exercises and topical diclofenac sodium 1% gel over 6 weeks. The control group will receive education for joint protection and OA alone. Main inclusion criteria are pain ≥40 mm (Visual Analogue Scale, 0–100) at the base of the thumb, impairment in hand function ≥6 (Functional Index for Hand Osteoarthritis, 0–30) and radiographic thumb base OA (Kellgren Lawrence grade ≥2). Participants currently receiving any of the intervention components will be excluded. Outcomes will be measured at 2, 6 and 12 weeks. The primary outcome is change in pain and hand function from baseline to 6 weeks. Other outcomes include changes in grip and pinch strength, quality of life, presence of joint swelling and tenderness, duration of joint stiffness, patient's global assessment and use of rescue medication. Analysis will be performed according to the intention-to-treat principle. Adverse events will be monitored throughout the study.

Ethics and dissemination This protocol is approved by the local ethics committee (HREC/15/HAWKE/479). Dissemination will occur through presentations at international conferences and publication in peer-reviewed journals.

Trial registration number ACTRN12616000353493; Pre-results.

  • osteoarthritis
  • thumb
  • conservative

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 and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

http://dx.doi.org/10.1136/bmjopen-2016-014498

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    Footnotes

    • Twitter Follow David Hunter @ProfDavidHunter and Bill Vicenzino @Bill_Vicenzino

    • Contributors LAD, DJH, AW, KLB, BV, PH, EAR, JPE, RJ and SRFM contributed to study conception and design. VD, ROC and WMO contributed to study design. DJH, KLB, BV, PH and SRFM attained project funding. LAD drafted the first version of the manuscript. ROC will have access to the final trial data set and perform the statistical analysis. All authors revised the protocol critically for important intellectual content and read and approved the final version of the protocol. All authors agree to be accountable for all aspects of the work.

    • Funding This work was supported by National Health and Medical Research Council (NHMRC) Program Grant (grant number APP1091302) and by the Lincoln Centre for Bone and Joint Diseases. KLB is supported by an NHMRC Principal Research Fellowship. DJH is supported by an NHMRC Practitioner Fellowship.

    • Disclaimer The funder had no role in the study design.

    • Competing interests DJH is a consultant to Flexion, Nestle and Merck Serono.

    • Ethics approval Local ethics committee Royal North Shore Hospital (HREC/15/HAWKE/479).

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