Efficacy of arch contouring foot orthoses for midfoot osteoarthritis: Protocol for a randomised controlled trial.

INTRODUCTION: Midfoot osteoarthritis (OA) is a painful and disabling condition. Arch contouring foot orthoses have been recommended for midfoot OA, yet there is no high-quality evidence from randomised controlled trials to support their use. This clinical trial aims to evaluate the efficacy of arch contouring foot orthoses for midfoot OA. METHODS: This will be a parallel-group randomised controlled superiority trial. One-hundred and forty community-dwelling people with painful midfoot OA will be randomised to receive either arch contouring foot orthoses or flat sham inserts. Outcome measures will be obtained at baseline, 4, 8 and 12 weeks; the primary endpoint for assessing efficacy being 12 weeks. The primary outcome measure will be average midfoot pain whilst walking over the last 7 days on an 11-point numerical rating scale. Secondary outcome measures include function (walking/standing subscale of the Manchester-Oxford Foot Questionnaire), participants' perception of overall treatment effect (self-reported global rating of change on a 15-point Likert scale), physical activity (Incidental and Planned Exercise Questionnaire), general health-related quality of life (Short Form-12 Version® 2.0), use of co-interventions and adverse events. DISCUSSION: This trial will evaluate the efficacy of arch contouring foot orthoses for relieving pain and improving function, physical activity and health-related quality of life in people with midfoot OA. The findings will provide high-quality evidence as to whether arch contouring foot orthoses are efficacious and will help to inform clinical guidelines about the use of foot orthoses for midfoot OA. TRIAL REGISTRATION: Australian and New Zealand Clinical Trial Registry (ACTRN12623000953639).

Effectiveness of footwear and foot orthoses in reducing medial metatarsophalangeal joint pressure in women with hallux valgus.

BACKGROUND: Hallux valgus is a common condition where the subluxation of the first metatarsophalangeal joint and lateral deviation of the hallux at the interphalangeal joint creates difficulty with footwear fit. Footwear and foot orthoses are commonly prescribed nonsurgical treatments for hallux valgus. RESEARCH QUESTION: Do extra-width footwear and foot orthoses influence peak pressure at the medial aspect of the metatarsophalangeal and interphalangeal joints in women with hallux valgus? METHODS: Community-dwelling women with symptomatic hallux valgus underwent gait testing when wearing their own shoes and when wearing extra-width footwear fitted with three-quarter length, arch-contouring prefabricated foot orthoses. Peak pressure (kPa) on the medial aspect of the metatarsophalangeal and medial interphalangeal joints and on the plantar surface of the foot (hallux, lesser toes, metatarsophalangeal joint 1, metatarsophalangeal joints 2-5, midfoot and heel) were measured using the novel pedar®-X system with the pedar® pad and pedar® insole, respectively (Novel, GmbH, Munich, Germany). Paired samples t-tests were used to calculate the differences between the two conditions, and the magnitude of observed differences was calculated using Cohen's d. RESULTS: We tested 28 participants (aged 44-80 years, mean 60.7, standard deviation 10.7). Compared to their own footwear, wearing the intervention footwear and orthoses was associated with a statistically significant decrease in pressure on the medial aspect of the metatarsophalangeal joint (58.3 ± 32.8 versus 42.6 ± 32.8, p=0.026, d=0.49), increased pressure under the midfoot (70.7 ± 25.7 versus 78.7 ± 23.6, p=0.029, d=0.33) and decreased pressure underneath the heel (137.3 ± 39.0 versus 121.3 ± 34.8, p=0.019, d=0.45). SIGNIFICANCE: The intervention footwear and orthoses significantly decreased peak pressure on the medial aspect of the first metatarsophalangeal joint but had no significant effect on the interphalangeal joint. Further studies are required to determine whether these changes are associated with improvements in symptoms associated with hallux valgus.

Nonsurgical management of hallux valgus: findings of a randomised pilot and feasibility trial.

BACKGROUND: Hallux valgus is a common and disabling condition. This randomised pilot and feasibility trial aimed to determine the feasibility of conducting a parallel group randomised trial to evaluate the effectiveness of a nonsurgical intervention for reducing pain associated with hallux valgus. METHODS: Twenty-eight community-dwelling women with painful hallux valgus were randomised to receive either a multifaceted, nonsurgical intervention (footwear, foot orthoses, foot exercises, advice, and self-management) or usual care (advice and self-management alone). Outcome measures were obtained at baseline, 4, 8 and 12 weeks. The primary outcome was feasibility, evaluated according to demand (recruitment rate and conversion rate), acceptability, adherence, adverse events, and retention rate. Limited efficacy testing was conducted on secondary outcome measures including foot pain, foot muscle strength, general health-related quality of life, use of cointerventions, and participants' perception of overall treatment effect. RESULTS: Between July 8, 2021, and April 22, 2022, we recruited and tested 28 participants (aged 44 to 80 years, mean 60.7, standard deviation 10.7). This period encompassed two COVID-related stay-at-home orders (July 16 to July 27, and August 5 to October 21, 2021). The predetermined feasibility thresholds were met for retention rate, foot pain, mental health-related quality of life, and use of cointerventions, partly met for acceptability, adverse events, and muscle strength, and not met for demand (recruitment rate or conversion rate), adherence, physical health-related quality of life and perception of overall treatment effect. CONCLUSION: In its current form, a randomised trial of footwear, foot orthoses, foot exercises, advice and self-management for relieving pain associated with hallux valgus is not feasible, particularly due to the low adherence with the intervention. However, it is difficult to determine whether the trial would be feasible under different circumstances, particularly due to COVID-19 stay-at-home orders. Future trials will need to consider improving the aesthetics of the footwear and making the exercise program less burdensome. TRIAL REGISTRATION: Australian and New Zealand Clinical Trial Registry (ACTRN12621000645853).

Efficacy of non-surgical interventions for midfoot osteoarthritis: a systematic review.

This systematic review aims to investigate the efficacy of non-surgical interventions for midfoot osteoarthritis (OA). Key databases and trial registries were searched from inception to 23 February 2023. All trials investigating non-surgical interventions for midfoot OA were included. Quality assessment was performed using the National Institutes of Health Quality Assessment Tool. Outcomes were pain, function, health-related quality of life, and adverse events. Effects (mean differences, standardised mean differences, risk ratios) were calculated where possible for the short (0 to 12 weeks), medium (> 12 to 52 weeks), and long (> 52 weeks) term. Six trials (231 participants) were included (one feasibility trial and five case series) - all were judged to be of poor methodological quality. Two trials reported arch contouring foot orthoses to exert no-to-large effects on pain in the short and medium term, and small-to-very-large effects on function in the short and medium term. Two trials reported shoe stiffening inserts to exert medium-to-huge effects on pain in the short term, and small effects on function in the short term. Two trials of image-guided intra-articular corticosteroid injections reported favourable effects on pain in the short term, small effects on pain and function in the medium term, and minimal long term effects. Two trials reported minor adverse events, and none reported health-related quality of life outcomes. The current evidence suggests that arch contouring foot orthoses, shoe stiffening inserts and corticosteroid injections may be effective for midfoot OA. Rigorous randomised trials are required to evaluate the efficacy of non-surgical interventions for midfoot OA.