Abstract
BackgroundFirst metatarsophalangeal (MTP) joint osteoarthritis (OA) is a painful and debilitating condition affecting nearly one in 10 people aged over 50 years. Non-drug, non-surgical treatments are recommended by OA clinical guidelines, yet there have only ever been two randomised controlled trials (RCTs) evaluating such strategies in people with first MTP joint OA. Foot orthoses are a common non-drug, non-surgical strategy used by allied health professionals for people with first MTP joint OA, however, it is unknown whether these devices are effective in improving the symptoms associated with the condition. This clinical trial aimed to determine whether contoured foot orthoses lead to greater reductions in first MTP joint pain on walking compared to sham flat insoles in people with first MTP joint OA.MethodsThe FORT trial (Foot ORthoses for big Toe joint osteoarthritis) is a two-arm participant- and assessor-blinded, multi-site RCT conducted in Melbourne, Sydney, Brisbane and the Gold Coast, Australia. We are recruiting 88 community-dwelling people with symptomatic radiographic first MTP joint OA. Following baseline assessment, participants are randomized to receive either: i) contoured foot orthoses; or ii) sham flat insoles following baseline assessment. Participants have two visits with a study podiatrist where they are provided with their allocated insoles, to be worn daily for 12 weeks at all times when wearing shoes. The primary outcome is self-reported first MTP joint pain on walking (numerical rating scale), assessed at baseline and 12 weeks. Secondary outcomes include additional measures of first MTP joint and foot pain, physical function, quality of life, participant-perceived global ratings of change (pain and function), and level of physical activity.DiscussionThis study will provide novel evidence about whether contoured foot orthoses improve pain and other symptoms compared to sham insoles in people with first MTP joint OA. Outcomes will help to inform clinical guidelines and practice about the use of foot orthoses for managing symptoms in this under-researched group of people with OA.Trial registrationProspectively registered with the Australian New Zealand Clinical Trials Registry (reference: ACTRN12619000926134) on 3/07/2019.
Highlights
First metatarsophalangeal (MTP) joint osteoarthritis (OA) is a painful and debilitating condition affecting nearly one in 10 people aged over 50 years
Primary outcome First MTP joint pain on walking Overall average pain intensity on walking in the last week is assessed at baseline and 12-weeks using an 11-point numerical rating scale (NRS) with terminal descriptors of Physical activity Physical activity over the previous week is measured using the Physical Activity Scale for the Elderly (PASE) [35] which has been validated against accelerometry [36]
The funders have no role in conduct, analysis or reporting of this study. This protocol outlines the first Randomised controlled trial (RCT) comparing the effects of contoured foot orthoses to sham flat insoles on pain and other symptoms in people with first MTP joint OA
Summary
Study design The FORT (Foot ORthoses for big Toe joint osteoarthritis) RCT is a participant- and assessor-blinded trial, conducted at sites in Melbourne, Sydney, Brisbane and the Gold Coast in Australia. Participants in both groups have two visits with a study podiatrist, one in week 1 and one in week 3. Secondary outcomes Foot pain Foot pain over the past week is measured using the pain subscale of the Foot Health Status Questionnaire (FHSQ), a foot-specific tool with high internal consistency and testretest reliability [32] This subscale contains 4 questions related to overall foot pain, each rated on a 5-point Likert scale from 0 (none) to 4 (severe). Primary outcome First MTP joint pain on walking Overall average pain intensity on walking in the last week is assessed at baseline and 12-weeks using an 11-point numerical rating scale (NRS) with terminal descriptors of Physical activity Physical activity over the previous week is measured using the Physical Activity Scale for the Elderly (PASE) [35] which has been validated against accelerometry [36]. Final 12-week follow-up data collection was expected to be completed by August 2020, but this will be revised upon recommencement of recruitment
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