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Effectiveness of preformed foot orthoses in reducing lower limb pain, swollen and tender joints and in improving quality of life and gait parameters in children with juvenile idiopathic arthritis: a randomised controlled trial (Protocol)
  1. Antoni Fellas1,
  2. Davinder Singh-Grewal2,3,4,5,
  3. Jeffrey Chaitow2,
  4. Derek Santos6,
  5. Andrea Coda1
  1. 1 Faculty of Health and Medicine, School of Health Sciences, University of Newcastle, Newcastle, New South Wales, Australia
  2. 2 The Sydney Children’s Hospital Network, Randwick and Westmead, Australia
  3. 3 Discipline of Paediatrics and Child Health, University of Sydney, Sydney, New South Wales, Australia
  4. 4 School of Women’s and Children’s Health, University of New South Wales, Sydney, New South Wales, Australia
  5. 5 Discipline of Paediatrics, University of Western Sydney, Sydney, New South Wales, Australia
  6. 6 School of Health Sciences, Queen Margaret University, Edinburgh, UK
  1. Correspondence to Mr Antoni Fellas; antoni.fellas{at}


Background Many children and adolescents with juvenile idiopathic arthritis experience lower limb problems which may lead to physical disabilities significantly impacting on their quality of life and symptoms. Emerging evidence has identified the effective role of podiatry in the management of juvenile idiopathic arthritis, suggesting the clinical benefit of different orthotic therapies.

Methods This study will be a parallel-group designed, multicentre, randomised controlled trial, aiming to recruit 66 children and adolescents with juvenile idiopathic arthritis aged between 5 and 18 years. Those recruited will need to be diagnosed according to the International League of Associations for Rheumatology criteria, and present with lower limb joint pain, swelling and/or tenderness. Participants will be recruited from three outpatient hospital clinics in New South Wales, Australia. Participants will be randomly allocated to receive a trial or control intervention. The trial group will be prescribed a customised preformed foot orthoses; instead, the control group will receive a flat 1 mm insole with no corrective modifications. Primary outcome measure recorded will be pain. Secondary outcomes will be quality of life, foot disability, swollen and tender joint count and gait parameters (such as plantar pressures, walking speed, stance and swing time). The allocated foot orthoses will be worn for 12 months, with data collected at baseline, 4 weeks, 3, 6 and 12 months intervals. Group allocation will be concealed and all analyses will be carried out on an intention to treat.

Discussion The purpose of this trial is to explore the efficacy of a cost-effective, non-invasive podiatric intervention that will be prescribed at the initial biomechanical consultation. This approach will promote early clinical intervention, which is the gold standard in paediatric rheumatology. Furthermore, this study has the potential to provide new evidence for the effectiveness of a mechanical intervention alone to reduce swollen and tender joints in juvenile idiopathic arthritis.

Trial registration number This clinical trial has been registered with the Australian New Zealand Clinical Trials Registry: ACTRN12616001082493p. Ethics for this randomised controlled trial has been approved (16/09/21/4.03).

  • rheumatology

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  • Contributors AF, DS-G, DS, JC and AC were actively involved in the conception and design of the study. AF and AC drafted the protocol, and DS-G, DS and JC revised the draft and critically appraised for intellectual content. Finally, all authors read and approved the final manuscript prior to submitting for publication.

  • Funding University of Newcastle—part of a PhD scholarship.

  • Competing interests None declared.

  • Patient consent Obtained

  • Ethics approval Hunter New England Human Research Ethics Committee. Site authorisation has also been approved for all data collection sites by the relevant research governance committees. Ethical considerations: participants can withdraw from the trial at any stage without providing any reason. If participants in the trial group benefited from the FOs and their symptoms improved, they will be informed to keep them and given referral information to seek out further podiatric care if needed. If the trial intervention is found to be beneficial and data analysis confirms this, participants in the control group will be given the option of a free consultation and prescription of the trial FOs used in the study.

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

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