Shoe-stiffening inserts for first metatarsophalangeal joint osteoarthritis: a randomised trial

Munteanu, Shannon E.; Landorf, Karl B; McClelland, Jodie A.; Roddy, Edward; Cicuttini, Flavia Maria; Shiell, Alan; Auhl, Maria; Allan, Jamie J.; Buldt, Andrew K.; Menz, Hylton B.

doi:10.1016/j.joca.2021.02.002

Cited by 15 publications

(19 citation statements)

References 43 publications

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“…Therefore, as part of a larger randomized trial that evaluated the effectiveness of shoe-stiffening inserts for the treatment of first MTP joint OA (17,18), we conducted a nested biomechanical study to examine the effects of shoe-stiffening inserts and sham inserts on sagittal plane kinematics of the first MTP, ankle, knee, and hip joints.…”

Section: Introductionmentioning

confidence: 99%

Effects of Shoe‐Stiffening Inserts on Lower Extremity Kinematics in Individuals With First Metatarsophalangeal Joint Osteoarthritis

McClelland

Allan

Auhl

et al. 2022

Arthritis Care & Research

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Section: Introductionmentioning

confidence: 99%

Effects of Shoe‐Stiffening Inserts on Lower Extremity Kinematics in Individuals With First Metatarsophalangeal Joint Osteoarthritis

McClelland

Allan

Auhl

et al. 2022

Arthritis Care & Research

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“…This study aims to determine the feasibility of conducting a RCT on the efficacy of prefabricated contoured foot orthoses in the treatment of people with hip OA, a potentially innovative and cost-effective solution to a burdensome condition. Adherence to wearing othoses is high in other lower limb musculoskeletal conditions, [46][47][48] with wear times of approximately 40 hours a week, 46 allowing for the potential to provide a therapeutic effect during family, recreational and social settings. High adherence rates and wear time also enhance the opportunity to receive a therapeutic benefit and demonstrate a clinical meaningful effect at minimal cost, and negligible adverse events.…”

Section: Discussionmentioning

confidence: 99%

Prefabricated contoured foot orthoses to reduce pain and increase physical activity in people with hip osteoarthritis: protocol for a randomised feasibility trial

et al. 2022

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IntroductionThe aim of this randomised feasibility trial is to determine the feasibility of conducting an adequately powered randomised controlled trial (RCT) investigating the efficacy of prefabricated contoured foot orthoses in people with hip osteoarthritis (OA). The secondary aims of the trial are to compare the effect of prefabricated contoured foot orthoses to a flat shoe insert comparator on outcomes of hip-related pain, physical activity and quality of life. We hypothesise that the demand, implementation, acceptability and practicality of foot orthoses as a treatment option for people with hip OA will be deemed feasible, informing the development of an adequately powered RCT to evaluate the efficacy and long term outcomes.Methods and analysisWe will recruit 28 people with hip OA who will be randomised to receive either prefabricated contoured foot orthoses or flat shoe inserts to use for a 6-week period. Both groups will receive standardised education on hip OA and physical activity. The study’s primary outcome is the feasibility domains of demand, implementation, acceptability and practicality. The secondary outcomes include the change in Hip Osteoarthritis Outcome Score-12, Patient Health Questionnaire-9, Brief Fear of Movement Scale for OA, Physical activity accelerometry and the Physical Activity Questionnaire-short form. Descriptive statistics will be used to describe feasibility outcomes with limited efficacy analysis used for the secondary outcomes. Linear mixed models will be used to analyse between-group differences at 6 weeks, with baseline values used as covariates, treatment allocation as a fixed factor and participant as a random factor.Ethics and disseminationThis trial has been approved by the La Trobe University Human Research Ethics Committee (HEC20427), St. Vincent’s Hospital Melbourne, Human Research Ethics Committee (HREC 266/20) and Northern Health Research Governance (NH-2021-292862). The results will be disseminated via a peer-reviewed journal and presented at international conferences.Trial registration numberNCT05138380.

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“…Carbon fibre shoe-stiffening inserts, which reduce the rate and magnitude of big toe dorsiflexion, were superior to sham shoe inserts for reducing first MTP OA pain in a RCT (n ¼ 90) by Munteanu et al 43 . Carbon fibre shoe-stiffening inserts improved pain at week 12 (measured by the 0e100 Foot Health Status Questionnaire, adjusted mean difference 6.66, 95% CI 0.65, 12.67), however, minimum important difference in pain was not achieved and stiffening inserts were also linked to increased likelihood of foot pain (at joints other than the first MTP joint).…”

Section: Theme 7: Novel Pharmacotherapy Trialsmentioning

confidence: 97%

Osteoarthritis year in review 2021: epidemiology & therapy

Quicke

Conaghan

Corp

et al. 2022

Osteoarthritis and Cartilage

207

120

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Shoe-stiffening inserts for first metatarsophalangeal joint osteoarthritis: a randomised trial

Cited by 15 publications

References 43 publications

Effects of Shoe‐Stiffening Inserts on Lower Extremity Kinematics in Individuals With First Metatarsophalangeal Joint Osteoarthritis

Effects of Shoe‐Stiffening Inserts on Lower Extremity Kinematics in Individuals With First Metatarsophalangeal Joint Osteoarthritis

Prefabricated contoured foot orthoses to reduce pain and increase physical activity in people with hip osteoarthritis: protocol for a randomised feasibility trial

Osteoarthritis year in review 2021: epidemiology & therapy

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