Dataset Information

Contoured, prefabricated foot orthoses demonstrate comparable mechanical properties to contoured, customised foot orthoses: a plantar pressure study.

ABSTRACT:

Background

Foot orthoses have been demonstrated to be effective in the management of a range of conditions, but there is debate as to the benefits of customised foot orthoses over less expensive, prefabricated devices.

Methods

In a randomised, cross-over trial, 15 flat-footed participants aged between 18 and 45 years were provided with semi-rigid, customised orthoses and semi-rigid, contoured, prefabricated orthoses. Pressures and forces were measured using an in-shoe system with subjects wearing shoes alone, wearing customised orthoses, and again when wearing contoured prefabricated orthoses. Two weeks acclimatisation was included between cross-over of therapy. Repeated measures ANOVA models with post-hoc, pair-wise comparisons were used to test for differences.

Results

When compared to wearing shoes alone, wearing either the customised orthoses or the prefabricated orthoses was associated with increases in force and force time integrals in the midfoot region. Peak and maximum mean pressure and pressure-time, and force-time integrals were reduced in both the medial and lateral forefoot. There were, however, no significant differences between the customised orthoses and the prefabricated orthoses at any site.

Conclusion

There was a similar change in loading with both the semi-rigid customised and the semi-rigid prefabricated orthoses when compared to the shoe alone condition. However, while customised devices offered minor differences over prefabricated orthoses in some variables, these were not statistically significant. The results suggest that there may be only minor differences in the effects on plantar pressures between the customised and the less expensive prefabricated orthoses tested in this study, however further research is warranted.

SUBMITTER: Redmond AC

PROVIDER: S-EPMC2711934 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundThe effectiveness of foot orthoses has been evaluated in many clinical trials with sham foot orthoses used as the control intervention in at least 10 clinical trials. However, the mechanical effects and credibility of sham orthoses has been rarely quantified. This study aimed to: (i) compare the effects on plantar pressures of three sham foot orthoses to a customised foot orthosis, and (ii) establish the perceived credibility and the expected benefit of each orthotic condition.MethodsThirty adults aged between 18 and 51 participated in this study. At 0 and 4 weeks, plantar pressure data were collected for the heel, midfoot and forefoot using the pedar(®)-X in-shoe system for the following five randomly assigned conditions: (i) shoe alone, (ii) customised foot orthosis, (iii) contoured polyethylene sham foot orthosis, (iv) contoured EVA sham foot orthosis, and (v) flat EVA sham foot orthosis. At the initial data collection session, each participant completed a Credibility/Expectancy Questionnaire (CEQ) to determine the credibility and expected benefit of each orthotic condition.ResultsCompared to the shoe alone at week 0, the contoured polyethylene sham orthosis was the only condition to not significantly effect peak pressure at any region of the foot. In contrast, the contoured EVA sham orthosis, the flat EVA sham orthosis and the customised orthosis significantly reduced peak pressure at the heel. At the medial midfoot, all sham orthoses provided the same effect as the shoe alone, which corresponded to effects that were significantly different to the customised orthosis. There were no differences in peak pressure between conditions at the other mask regions, the lateral midfoot and forefoot. When the conditions were compared at week 4, the differences between the conditions were generally similar to the findings observed at week 0. With respect to credibility and expected benefit, all orthotic conditions were considered the same with the exception of the contoured polyethylene sham orthosis, which was perceived as being less credible and less likely to provide benefits.ConclusionThe findings of this study indicate that all of the sham orthoses tested provided the same effect on plantar pressures at the midfoot and forefoot as a shoe alone. However, the contoured EVA sham orthosis and the flat EVA sham orthosis significantly reduced peak pressure under the heel, which was similar to the customised orthosis. In contrast, the contoured polyethylene sham orthosis had no significant effect on plantar pressure and was comparable to the shoe alone at all regions of the foot. Hence, lower plantar pressures were found under the heel with some sham orthoses, but not with others. Importantly, participants perceived the polyethylene sham orthosis - the sham that had no effect on plantar pressure - to be the least credible orthosis and the least likely to provide benefits. This may be critical for the design of future clinical trials as it may introduce confounding effects that produce inaccurate results. These findings provide some evidence for the mechanical effects, treatment credibility and expected benefit of sham foot orthoses, which should be considered when they are used as a control intervention in a clinical trial.

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Project description:Background Foot orthoses and corticosteroid injection are common interventions used for plantar heel pain, however few studies have investigated the variables that predict response to these interventions. Methods Baseline variables (age, weight, height, body mass index (BMI), sex, education, foot pain, foot function, fear-avoidance beliefs and feelings, foot posture, weightbearing ankle dorsiflexion, plantar fascia thickness, and treatment preference) from a randomised trial in which participants received either foot orthoses or corticosteroid injection were used to predict change in the Foot Health Status Questionnaire foot pain and foot function subscales, and first-step pain measured using a visual analogue scale. Multivariable linear regression models were generated for different dependent variables (i.e. foot pain, foot function and first-step pain), for each intervention (i.e. foot orthoses and corticosteroid injection), and at different timepoints (i.e. weeks 4 and 12). Results For foot orthoses at week 4, greater ankle dorsiflexion with the knee extended predicted reduction in foot pain (adjusted R2?=?0.16, p?=?0.034), and lower fear-avoidance beliefs and feelings predicted improvement in foot function (adjusted R2?=?0.43, p?=?0.001). At week 12, lower BMI predicted reduction in foot pain (adjusted R2?=?0.33, p?<?0.001), improvement in foot function (adjusted R2?=?0.37, p?<?0.001) and reduction in first-step pain (adjusted R2 0.19, p?=?0.011). For corticosteroid injection at week 4, there were no significant predictors for change in foot pain or foot function. At week 12, less weightbearing hours predicted reduction in foot pain (adjusted R2?=?0.25, p?=?0.004) and lower baseline foot pain predicted improvement in foot function (adjusted R2?=?0.38, p?<?0.001). Conclusions People with plantar heel pain who use foot orthoses experience reduced foot pain if they have greater ankle dorsiflexion and lower BMI, while they experience improved foot function if they have lower fear-avoidance beliefs and lower BMI. People who receive a corticosteroid injection experience reduced foot pain if they weightbear for fewer hours, while they experience improved foot function if they have less baseline foot pain.

Project description:BackgroundAchilles tendinopathy is a common condition that can cause marked pain and disability. Numerous non-surgical treatments have been proposed for the treatment of this condition, but many of these treatments have a poor or non-existent evidence base. The exception to this is eccentric calf muscle exercises, which have become a standard non-surgical intervention for Achilles tendinopathy. Foot orthoses have also been advocated as a treatment for Achilles tendinopathy, but the long-term efficacy of foot orthoses for this condition is unknown. This manuscript describes the design of a randomised trial to evaluate the efficacy of customised foot orthoses to reduce pain and improve function in people with Achilles tendinopathy.MethodsOne hundred and forty community-dwelling men and women aged 18 to 55 years with Achilles tendinopathy (who satisfy inclusion and exclusion criteria) will be recruited. Participants will be randomised, using a computer-generated random number sequence, to either a control group (sham foot orthoses made from compressible ethylene vinyl acetate foam) or an experimental group (customised foot orthoses made from semi-rigid polypropylene). Both groups will be prescribed a calf muscle eccentric exercise program, however, the primary difference between the groups will be that the experimental group receive customised foot orthoses, while the control group receive sham foot orthoses. The participants will be instructed to perform eccentric exercises 2 times per day, 7 days per week, for 12 weeks. The primary outcome measure will be the total score of the Victorian Institute of Sport Assessment - Achilles (VISA-A) questionnaire. The secondary outcome measures will be participant perception of treatment effect, comfort of the foot orthoses, use of co-interventions, frequency and severity of adverse events, level of physical activity and health-related quality of life (assessed using the Short-Form-36 questionnaire - Version two). Data will be collected at baseline, then at 1, 3, 6 and 12 months. Data will be analysed using the intention to treat principle.DiscussionThis study is the first randomised trial to evaluate the long-term efficacy of customised foot orthoses for the treatment of Achilles tendinopathy. The study has been pragmatically designed to ensure that the study findings are generalisable to clinical practice.Trial registrationAustralian New Zealand Clinical Trials Registry Number: ACTRN12609000829213.

Project description:UnlabelledBackgroundNeuropathic diabetic foot ulceration may be prevented if the mechanical stress transmitted to the plantar tissues is reduced. Insole therapy is one practical method commonly used to reduce plantar loads and ulceration risk. The type of insole best suited to achieve this is unknown. This trial compared custom-made functional insoles with prefabricated insoles to reduce risk factors for ulceration of neuropathic diabetic feet.MethodA participant-blinded randomised controlled trial recruited 119 neuropathic participants with diabetes who were randomly allocated to custom-made functional or prefabricated insoles. Data were collected at issue and six month follow-up using the F-scan in-shoe pressure measurement system. Primary outcomes were: peak pressure, forefoot pressure time integral, total contact area, forefoot rate of load, duration of load as a percentage of stance. Secondary outcomes were patient perceived foot health (Bristol Foot Score), quality of life (Audit of Diabetes Dependent Quality of Life). We also assessed cost of supply and fitting. Analysis was by intention-to-treat.ResultsThere were no differences between insoles in peak pressure, or three of the other four kinetic measures. The custom-made functional insole was slightly more effective than the prefabricated insole in reducing forefoot pressure time integral at issue (27% vs. 22%), remained more effective at six month follow-up (30% vs. 24%, p=0.001), but was more expensive (UK £656 vs. £554, p<0.001). Full compliance (minimum wear 7 hours a day 7 days per week) was reported by 40% of participants and 76% of participants reported a minimum wear of 5 hours a day 5 days per week. There was no difference in patient perception between insoles.ConclusionThe custom-made insoles are more expensive than prefabricated insoles evaluated in this trial and no better in reducing peak pressure. We recommend that where clinically appropriate, the more cost effective prefabricated insole should be considered for use by patients with diabetes and neuropathy.Trial registrationClinical trials.gov (NCT00999635). Note: this trial was registered on completion.