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

BACKGROUND: Hip osteoarthritis (OA) is a prevalent and burdensome condition that leads to impaired quality of life and a substantial economic burden. Encouraging physical activity, particularly walking, is crucial for OA management, but many individuals with hip OA fail to meet recommended activity levels. Prefabricated contoured foot orthoses have shown promise in improving hip muscle efficiency during walking in laboratory settings, but their real-world feasibility and efficacy remain uncertain. OBJECTIVE: The aim of this study was to assess the feasibility of conducting a fully powered randomised controlled trial (RCT) to evaluate the effectiveness of prefabricated contoured foot orthoses, prescribed via telehealth, in people with hip OA. METHODS: This feasibility trial randomised 27 participants with hip OA into two groups: prefabricated contoured foot orthoses or flat shoe inserts. Feasibility outcomes were assessed, including recruitment rate, adherence, logbook completion, and dropout rate. Patient-reported outcomes and accelerometer-measured physical activity were collected as secondary outcomes. RESULTS: While the recruitment rate was low (0.88 people/week), adherence to the intervention (59%), logbook completion (93%), and dropout rates (7%) met or exceeded our predefined feasibility parameters. Participants found the intervention acceptable, and practicality was demonstrated with minor adverse events. Preliminary efficacy testing indicated that prefabricated contoured foot orthoses positively affected physical activity (adjusted mean difference = 2590 [260 to 4920] steps/day), with comparable outcomes for hip-related quality of life and pain. CONCLUSION: This trial supports proceeding to a fully powered RCT to assess the effect of teleheath prescribed prefabricated contoured foot orthoses on physical activity in people with hip OA. STUDY REGISTRATION NUMBER: National Institutes of Health Trial Registry (NCT05138380).

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

INTRODUCTION: The 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 ANALYSIS: We 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 DISSEMINATION: This 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 NUMBER: NCT05138380.

A feasibility study of brain-targeted treatment for people with painful knee osteoarthritis in tertiary care.

Purpose: To assess the feasibility and clinical impact of brain-targeted treatment (BT; aiming to target sensorimotor processing) in knee osteoarthritis patients attending tertiary care. Methods: Randomized replicated case series. The study involved three phases, each of 2 weeks duration: (1) no-treatment phase; (2) BT phase (left/right judgments and touch discrimination training); and (3) usual care (education, strengthening, and stretching training). Primary outcomes were: timely recruitment; number of participants completing the interventions; treatment compliance and barriers; follow-up rates; and treatment impact on pain and function. Fear-avoidance beliefs and clinical measures of cortical body representation (tactile acuity and left/right judgment performance) were secondary outcomes. Results: A total of 5% (19/355) of all assessed patients were eligible to participate and of these, 58% (11/19) agreed to participate. Ten patients completed the study, and 9 were successfully followed up, with treatment compliance varying between interventions. Compliance was poor for the touch discrimination component of BT. No significant effects were observed for pain relief or knee function after any treatment. A positive impact of treatment was found for fear-avoidance beliefs (usual care vs. washout, p = 0.007; BT vs. washout, p = 0.029) and left/right judgment accuracy (usual care vs. washout; p = 0.006). Conclusions: Clear barriers were identified to implementing BT in tertiary care for knee osteoarthritis. Access to all available services (especially the use of interpreters), and treatment options that do not require additional assistance to perform (e.g., touch discrimination training) represent the main lessons learned.