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Randomized Controlled Trial
. 2018 May 31:11:24.
doi: 10.1186/s13047-018-0272-3. eCollection 2018.

A protocol for a randomised controlled trial of prefabricated versus customised foot orthoses for people with rheumatoid arthritis: the FOCOS RA trial [Foot Orthoses - Customised v Off-the-Shelf in Rheumatoid Arthritis]

Kellie S Gallagher  1 , Jon Godwin  2 , Gordon J Hendry  2 , Martijn Steultjens  2 , Jim Woodburn  2
Affiliations
Randomized Controlled Trial

A protocol for a randomised controlled trial of prefabricated versus customised foot orthoses for people with rheumatoid arthritis: the FOCOS RA trial [Foot Orthoses - Customised v Off-the-Shelf in Rheumatoid Arthritis]

Kellie S Gallagher et al. J Foot Ankle Res. .

Abstract

Background: Foot pain is common in rheumatoid arthritis and appears to persist despite modern day medical management. Several clinical practice guidelines currently recommend the use of foot orthoses for the treatment of foot pain in people with rheumatoid arthritis. However, an evidence gap currently exists concerning the comparative clinical- and cost-effectiveness of prefabricated and customised foot orthoses in people with early rheumatoid arthritis. Early intervention with orthotics may offer the best opportunity for positive therapeutic outcomes. The primary aim of this study is to evaluate the comparative clinical- and cost-effectiveness of prefabricated versus customised orthoses for reducing foot pain over 12 months.

Methods/design: This is a multi-centre two-arm parallel randomised controlled trial comparing prefabricated versus customised orthoses in participants with early rheumatoid arthritis (< 2 years disease duration). A total of 160 (a minimum of 80 randomised to each arm) eligible participants will be recruited from United Kingdom National Health Service Rheumatology Outpatient Clinics. The primary outcome will be foot pain measured via the Foot Function Index pain subscale at 12 months. Secondary outcomes will include foot related impairments and disability via the Foot Impact Scale for rheumatoid arthritis, global functional status via the Stanford Health Assessment Questionnaire, foot disease activity via the Rheumatoid Arthritis Foot Disease Activity Index, and health-related quality of life at baseline, 6 and 12 months. Process outcomes will include recruitment/retention rates, data completion rates, intervention adherence rates, and participant intervention and trial participation satisfaction. Cost-utility and cost-effectiveness analyses will be undertaken.

Discussion: Outcome measures collected at baseline, 6 and 12 months will be used to evaluate the comparative clinical- and cost- effectiveness of customised versus prefabricated orthoses for this treatment of early rheumatoid arthritis foot conditions. This trial will help to guide orthotic prescription recommendations for the management of foot pain for people with early rheumatoid arthritis in future.

Trial registration: ISRCTN13654421. Registered 09 February 2016.

Keywords: Cost-effectiveness; Orthoses; Randomised controlled trial; Rheumatoid arthritis.

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Conflict of interest statement

Ethical approval for this study has been obtained by the East of England – Essex Research Ethics Committee Ref: 15/EE/0410. Written consent will be obtained for all participants recruited for this trial.The authors declare that they have no competing interests.Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
CONSORT flow diagram outlining the flow of participants through the trial
Fig. 2
Fig. 2
Summary of prefabricated foot orthoses prescription protocol
Fig. 3
Fig. 3
Summary of customised foot orthoses prescription protocol
See this image and copyright information in PMC

References

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