Abstract
BackgroundThis article describes the design of a parallel-group, participant- and assessor-blinded randomised controlled trial comparing the effectiveness of shoe-stiffening inserts versus sham shoe insert(s) for reducing pain associated with first metatarsophalangeal joint (MTPJ) osteoarthritis (OA).MethodsNinety participants with first MTPJ OA will be randomised to receive full-length shoe-stiffening insert(s) (Carbon Fibre Spring Plate, Paris Orthotics, Vancouver, BC, Canada) plus rehabilitation therapy or sham shoe insert(s) plus rehabilitation therapy. Outcome measures will be obtained at baseline, 4, 12, 24 and 52 weeks; the primary endpoint for assessing effectiveness being 12 weeks. The primary outcome measure will be the foot pain domain of the Foot Health Status Questionnaire (FHSQ). Secondary outcome measures will include the function domain of the FHSQ, severity of first MTPJ pain (using a 100-mm Visual Analogue Scale), global change in symptoms (using a 15-point Likert scale), health status (using the Short-Form-12® Version 2.0 and EuroQol (EQ-5D-5L™) questionnaires), use of rescue medication and co-interventions, self-reported adverse events and physical activity levels (using the Incidental and Planned Activity Questionnaire). Data will be analysed using the intention-to-treat principle. Economic analysis (cost-effectiveness and cost-utility) will also be performed. In addition, the kinematic effects of the interventions will be examined at 1 week using a three-dimensional motion analysis system and multisegment foot model.DiscussionThis study will determine whether shoe-stiffening inserts are a cost-effective intervention for relieving pain associated with first MTPJ OA. The biomechanical analysis will provide useful insights into the mechanism of action of the shoe-stiffening inserts.Trial registrationAustralian New Zealand Clinical Trials Registry, identifier: ACTRN12616000552482. Registered on 28 April 2016.
Highlights
This article describes the design of a parallel-group, participant- and assessor-blinded randomised controlled trial comparing the effectiveness of shoe-stiffening inserts versus sham shoe insert(s) for reducing pain associated with first metatarsophalangeal joint (MTPJ) osteoarthritis (OA)
First metatarsophalangeal joint (MTPJ) osteoarthritis (OA) (International Classification of Diseases (ICD-10) code M20.20) is a common degenerative disorder of the foot estimated to occur in 7.8% in people aged 50 years or older, with a higher prevalence observed in women, older people, and those from lower socioeconomic backgrounds [1]
We have found that prefabricated arch-contouring foot orthoses with a cut-out beneath the first MTPJ are effective as rockersole footwear for reducing foot pain in people with this condition [14]
Summary
This article describes the design of a parallel-group, participant- and assessor-blinded randomised controlled trial comparing the effectiveness of shoe-stiffening inserts versus sham shoe insert(s) for reducing pain associated with first metatarsophalangeal joint (MTPJ) osteoarthritis (OA). There are structural changes (joint-space narrowing and the formation of osteophytes at the dorsal aspect) that characterise first MTPJ OA and lead to a restriction in dorsiflexion motion at the joint. The restricted joint dorsiflexion that occurs in first MTPJ OA is associated with overloading of the hallux and lesser forefoot during propulsion [6, 7], as well as a shortened step length and longer stance phase duration [8]. These changes may lead to the development of secondary musculoskeletal complaints
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