Treating Heel Pain in Adults: A Randomized Controlled Trial of Hard vs Modified Soft Custom Orthotics and Heel Pads.

OBJECTIVES: This study compared the effectiveness of soft vs hard orthotics in treating heel pain and plantar fasciitis in adults. It also compared the level of function after orthotic use, cost, and number of visits for orthotics and explored whether age was a factor in orthotic effectiveness. DESIGN: Randomized controlled trial. Before randomization, patients were stratified by age (younger vs older adults) in blocks of 4 to ensure that there were an equal number of participants in each group (soft vs hard orthotics). SETTING: An orthotic clinic in a community-based hospital and a private orthotic clinic. PARTICIPANTS: The participants were adults aged 18 years or older (N=44) with heel pain and plantar fasciitis. INTERVENTION: Participants received hard or soft customized orthotics. MAIN OUTCOME MEASURES: Participants rated their pain intensity and pain interference before and after orthotic use using subscales from the Brief Pain Inventory. Function was similarly measured using the Late Life Function and Disability Instrument: Function component. Analyses of age, cost, and number of visits were also compared. RESULTS: There was a reduction in pain intensity (P=.010) and pain interference (P<.001) but no change in function over time (P=.333), and no difference between the groups who received hard vs soft orthotics. Age had no effect on orthotic effectiveness. Soft orthotics were less expensive (P<.0001) and required fewer visits for fabrication (P<.0001). CONCLUSION: Both soft and hard orthotics provided effective pain relief, but soft orthotics are less expensive.

Cost-effectiveness of 12 weeks of supervised treatment compared to written advice in patients with knee osteoarthritis: a secondary analysis of the 2-year outcome from a randomized trial.

OBJECTIVE: To assess the 24-month cost-effectiveness of supervised treatment compared to written advice in knee osteoarthritis (OA). DESIGN: 100 adults with moderate-severe OA not eligible for total knee replacement (TKR) randomized to a 12-week individualized, supervised treatment (exercise, education, diet, insoles and pain medication) or written advice. Effectiveness was measured as change in quality-adjusted life years (QALYs) from baseline to 24 months, including data from baseline, 3, 6, 12 and 24 months, while healthcare costs and transfer payments were derived from national registries after final follow-up. Incremental costs, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs) were calculated. A sensitivity analysis resampling existing data was conducted and the probability of cost-effectiveness was estimated using a 22,665 Euros/QALY threshold. In a sensitivity analysis, cost-effectiveness was calculated for different costs of the supervised treatment (actual cost in study; cost in private practice; and in-between cost). RESULTS: Average costs were similar between groups (6,758 Euros vs 6,880 Euros), while the supervised treatment were close to being more effective (incremental effect (95% CI) of 0.075 (-0.005 to 0.156). In the primary analysis excluding deaths, this led the supervised treatment to be cost-effective, compared to written advice. The sensitivity analysis demonstrated that the results were sensitive to changes in the cost of treatment, but in all scenarios the supervised treatment was cost-effective (ICERs of 6,229 to 20,688 Euros/QALY). CONCLUSIONS: From a 24-month perspective, a 12-week individualized, supervised treatment program is cost-effective compared to written advice in patients with moderate-severe knee OA not eligible for TKR. TRIAL REGISTRATION: ClinicalTrials.gov number: NCT01535001.

Systematic review on the comparative effectiveness of foot orthoses in patients with rheumatoid arthritis.

BACKGROUND: Foot orthoses (FOs) are prescribed as an important conservative treatment option in patients with foot problems related to rheumatoid arthritis. However, a broad variation in FOs is used, both in clinical practice and in research. To date, there is no overview on the outcomes of the treatment with different kinds of FOs in patients with rheumatoid arthritis and a specific foot problem. The objectives of the present study were to summarize the comparative effectiveness of FOs in the treatment of various foot problems in patients with rheumatoid arthritis, on the primary outcomes foot function and foot pain, and the secondary outcomes physical functioning, health related quality of life, compliance, adverse events, the costs of FOs and patient satisfaction. METHODS: Studies comparing different kinds of FOs, with a presumed therapeutic effect, in the treatment of foot problems related to rheumatoid arthritis were included. A literature search was conducted in The Cochrane Central Registry for Controlled Trials (CENTRAL), PubMed, EMBASE and PEDro up to May 18th, 2018. Data was meta-analyzed, when this was not possible qualitative data analysis was performed. RESULTS: Ten studies were identified, with a total number of 235 patients. These studies made a comparison between different materials used (soft versus semi-rigid), types of FOs (custom-made versus ready-made; total-contact versus non-total contact), or modifications applied (metatarsal bars versus domes). Also, different techniques to construct custom-made FOs were compared (standard custom-molding techniques versus more sophisticated techniques). A medium effect for (immediate) reduction of forefoot plantar pressure was found in favor of treatment with soft FOs compared to semi-rigid FOs (SMD 0.60, 95% CI 0.07-1.14; P = 0.03; 28 participants). Other comparisons between FOs resulted in non-significant effects or inconclusive evidence for one kind of FOs over the other. CONCLUSIONS: Foot orthoses made of soft materials may lead to more (immediate) forefoot plantar pressure reduction compared to foot orthoses constructed of semi-rigid materials. Definitive high quality RCTs, with adequate sample sizes and long-term follow-up, are needed to investigate the comparative (cost-) effectiveness of different kinds of foot orthoses for the treatment of foot problems related to rheumatoid arthritis.

The clinical- and cost-effectiveness of functional electrical stimulation and ankle-foot orthoses for foot drop in Multiple Sclerosis: a multicentre randomized trial.

OBJECTIVE: To compare the clinical- and cost-effectiveness of ankle-foot orthoses (AFOs) and functional electrical stimulation (FES) over 12 months in people with Multiple Sclerosis with foot drop. DESIGN: Multicentre, powered, non-blinded, randomized trial. SETTING: Seven Multiple Sclerosis outpatient centres across Scotland. SUBJECTS: Eighty-five treatment-naïve people with Multiple Sclerosis with persistent (>three months) foot drop. INTERVENTIONS: Participants randomized to receive a custom-made, AFO (n = 43) or FES device (n = 42). OUTCOME MEASURES: Assessed at 0, 3, 6 and 12 months; 5-minute self-selected walk test (primary), Timed 25 Foot Walk, oxygen cost of walking, Multiple Sclerosis Impact Scale-29, Multiple Sclerosis Walking Scale-12, Modified Fatigue Impact Scale, Euroqol five-dimension five-level questionnaire, Activities-specific Balance and Confidence Scale, Psychological Impact of Assistive Devices Score, and equipment and National Health Service staff time costs of interventions. RESULTS: Groups were similar for age (AFO, 51.4 (11.2); FES, 50.4(10.4) years) and baseline walking speed (AFO, 0.62 (0.21); FES 0.73 (0.27) m/s). In all, 38% dropped out by 12 months (AFO, n = 21; FES, n = 11). Both groups walked faster at 12 months with device (P < 0.001; AFO, 0.73 (0.24); FES, 0.79 (0.24) m/s) but no difference between groups. Significantly higher Psychological Impact of Assistive Devices Scores were found for FES for Competence (P = 0.016; AFO, 0.85(1.05); FES, 1.53(1.05)), Adaptability (P = 0.001; AFO, 0.38(0.97); FES 1.53 (0.98)) and Self-Esteem (P = 0.006; AFO, 0.45 (0.67); FES 1 (0.68)). Effects were comparable for other measures. FES may offer value for money alternative to usual care. CONCLUSION: AFOs and FES have comparable effects on walking performance and patient-reported outcomes; however, high drop-outs introduces uncertainty.

A randomised controlled trial and cost-consequence analysis of traditional and digital foot orthoses supply chains in a National Health Service setting: application to feet at risk of diabetic plantar ulceration.

BACKGROUND: Diabetic foot ulceration is a considerable cost to the NHS and foot orthotic provision is a core strategy for the management of the people with diabetes and a moderate to high risk of foot ulceration. The traditional process to produce a custom-made foot orthotic device is to use manual casting of foot shape and physical moulding of orthoses materials. Parts of this process can be undertaken using digital tools rather than manual processes with potential advantages. The aim of this trial was to provide the first comparison of a traditional orthoses supply chain to a digital supply chain over a 6 month period. The trial used plantar pressure, health status, and health service time and cost data to compare the two supply chains. METHODS: Fifty-seven participants with diabetes were randomly allocated to each supply chain. Plantar pressure data and health status (EQ5D, ICECAP) was assessed at point of supply and at six-months. The costs for orthoses and clinical services accessed by participants were assessed over the 6 months of the trial. Primary outcomes were: reduction in peak plantar pressure at the site of highest pressure, assessed for non-inferiority to current care. Secondary outcomes were: reduction in plantar pressure at foot regions identified as at risk (> 200 kPa), cost-consequence analysis (supply chain, clinician time, service use) and health status. RESULTS: At point of supply pressure reduction for the digital supply chain was non-inferior to a predefined margin and superior (p < 0.1) to the traditional supply chain, but both supply chains were inferior to the margin after 6 months. Custom-made orthoses significantly reduced pressure for at risk regions compared to a flat control (traditional - 13.85%, digital - 20.52%). The digital supply chain was more expensive (+£13.17) and required more clinician time (+ 35 min). There were no significant differences in health status or service use between supply chains. CONCLUSIONS: Custom made foot orthoses reduce pressure as expected. Given some assumptions about the cost models we used, the supply chain process adopted to produce the orthoses seems to have marginal impact on overall costs and health status. TRIAL REGISTRATION: Retrospectively registered on ISRCTN registry (ISRCTN10978940, 04/11/2015).

Cost-Effectiveness of a Multifaceted Podiatry Intervention for the Prevention of Falls in Older People: The REducing Falls with Orthoses and a Multifaceted Podiatry Intervention Trial Findings.

BACKGROUND: Falls are a major cause of morbidity among older people. Multifaceted interventions may be effective in preventing falls and related fractures. OBJECTIVE: To evaluate the cost-effectiveness alongside the REducing Falls with Orthoses and a Multifaceted podiatry intervention (REFORM) trial. METHODS: REFORM was a pragmatic multicentre cohort randomised controlled trial in England and Ireland; 1,010 participants (> 65 years) were randomised to receive either a podiatry intervention (n = 493), including foot and ankle strengthening exercises, foot orthoses, new footwear if required, and a falls prevention leaflet, or usual podiatry treatment plus a falls prevention leaflet (n = 517). PRIMARY OUTCOME: incidence of falls per participant in the 12 months following randomisation. SECONDARY OUTCOMES: proportion of fallers and quality of life (EQ-5D-3L) which was converted into quality-adjusted life years (QALYs) for each participant. Differences in mean costs and QALYs at 12 months were used to assess the cost-effectiveness of the intervention relative to usual care. Cost-effectiveness analyses were conducted in accordance with National Institute for Health and Clinical Excellence reference case standards, using a regression-based approach with costs expressed in GBP (2015 price). The base case analysis used an intention-to-treat approach on the imputed data set using multiple imputation. RESULTS: There was a small, non-statistically significant reduction in the incidence rate of falls in the intervention group (adjusted incidence rate ratio 0.88, 95% CI 0.73-1.05, p = 0.16). Participants allocated to the intervention group accumulated on average marginally higher QALYs than the usual care participants (mean difference 0.0129, 95% CI -0.0050 to 0.0314). The intervention costs were on average GBP 252 more per participant compared to the usual care participants (95% CI GBP -69 to GBP 589). Incremental cost-effectiveness ratios ranged between GBP 19,494 and GBP 20,593 per QALY gained, below the conventional National Health Service cost-effectiveness thresholds of GBP 20,000 to GBP 30,000 per additional QALY. The probability that the podiatry intervention is cost-effective at a threshold of GBP 30,000 per QALY gained was 0.65. The results were robust to sensitivity analyses. CONCLUSION: The benefits of the intervention justified the moderate cost. The intervention could be a cost-effective option for falls prevention when compared with usual care in the UK.

A protocol for a randomised controlled trial of prefabricated versus customised foot orthoses for people with rheumatoid arthritis: the FOCOS RA trial [Foot Orthoses - Customised v Off-the-Shelf in Rheumatoid Arthritis].

BACKGROUND: Foot pain is common in rheumatoid arthritis and appears to persist despite modern day medical management. Several clinical practice guidelines currently recommend the use of foot orthoses for the treatment of foot pain in people with rheumatoid arthritis. However, an evidence gap currently exists concerning the comparative clinical- and cost-effectiveness of prefabricated and customised foot orthoses in people with early rheumatoid arthritis. Early intervention with orthotics may offer the best opportunity for positive therapeutic outcomes. The primary aim of this study is to evaluate the comparative clinical- and cost-effectiveness of prefabricated versus customised orthoses for reducing foot pain over 12 months. METHODS/DESIGN: This is a multi-centre two-arm parallel randomised controlled trial comparing prefabricated versus customised orthoses in participants with early rheumatoid arthritis (< 2 years disease duration). A total of 160 (a minimum of 80 randomised to each arm) eligible participants will be recruited from United Kingdom National Health Service Rheumatology Outpatient Clinics. The primary outcome will be foot pain measured via the Foot Function Index pain subscale at 12 months. Secondary outcomes will include foot related impairments and disability via the Foot Impact Scale for rheumatoid arthritis, global functional status via the Stanford Health Assessment Questionnaire, foot disease activity via the Rheumatoid Arthritis Foot Disease Activity Index, and health-related quality of life at baseline, 6 and 12 months. Process outcomes will include recruitment/retention rates, data completion rates, intervention adherence rates, and participant intervention and trial participation satisfaction. Cost-utility and cost-effectiveness analyses will be undertaken. DISCUSSION: Outcome measures collected at baseline, 6 and 12 months will be used to evaluate the comparative clinical- and cost- effectiveness of customised versus prefabricated orthoses for this treatment of early rheumatoid arthritis foot conditions. This trial will help to guide orthotic prescription recommendations for the management of foot pain for people with early rheumatoid arthritis in future. TRIAL REGISTRATION: ISRCTN13654421. Registered 09 February 2016.

Clinical effectiveness and cost-effectiveness of foot orthoses for people with established rheumatoid arthritis: an exploratory clinical trial.

OBJECTIVES: Foot orthoses are commonly prescribed as an intervention for people with rheumatoid arthritis (RA). Data relating to the cost-effectiveness of foot orthoses in people with RA are limited. The aim was to evaluate the clinical and cost-effectiveness of two types of foot orthoses in people with established RA. METHOD: A single-blind randomized controlled trial was undertaken to compare custom-made foot orthoses (CMFOs) and simple insoles (SIs) in 41 people with established RA. The Foot Function Index (FFI) was used to measure foot pain, disability, and functional limitation. Costs were estimated from the perspective of the UK National Health Service (NHS), societal (patient and family) perspective, and secondary care resource use in terms of the intervention and staff time. Effects were assessed in terms of health gain expressed as quality-adjusted life years (QALYs). RESULTS: At baseline, 20 participants received a CMFO and 21 participants received an SI. After 16 weeks foot pain improved in both the CMFOs (p = 0.000) and the SIs (p < 0.01). However, disability scores improved for CMFOs (p < 0.001) but not for SIs (p = 0.40). The cost-effectiveness results demonstrated no difference in cost between the arms (CMFOs: £159.10; SIs: £79.10; p = 0.35), with the CMFOs being less effective in terms of cost per QALY gain (p < 0.001). CONCLUSIONS: In people with established RA, semi-rigid customized foot orthoses can improve pain and disability scores in comparison to simple insoles. From a cost-effectiveness perspective, the customized foot orthoses were far more expensive to manufacture, with no significant cost per QALY gain.

The STAP-study: The (cost) effectiveness of custom made orthotic insoles in the treatment for plantar fasciopathy in general practice and sports medicine: design of a randomized controlled trial.

BACKGROUND: Plantar fasciopathy is a common cause of foot pain, accounting for 11 to 15% of all foot symptoms requiring professional care in adults. Although many patients have complete resolution of symptoms within 12 months, many patients wish to reduce this period as much as possible. Orthotic devices are a frequently applied option of treatment in daily practice, despite a lack of evidence on the effectiveness. Therefore, the objective is to study the (cost)-effectiveness of custom made insoles by a podiatrist, compared to placebo insoles and usual care in patients with plantar fasciopathy in general practice and sports medicine clinics. METHOD/DESIGN: This study is a multi-center three-armed participant and assessor-blinded randomized controlled trial with 6-months follow-up. Patients with plantar fasciopathy, with a minimum duration of complaints of 2 weeks and aged between 18 and 65, who visit their general practitioner or sport physician are eligible for inclusion. A total of 185 patients will be randomized into three parallel groups. One group will receive usual care by the general practitioner or sports physician alone, one group will be referred to a podiatrist and will receive a custom made insole, and one group will be referred to a podiatrist and will receive a placebo insole. The primary outcome will be the change from baseline to 12 weeks follow-up in pain severity at rest and during activity on a 0-10 numerical rating scale (NRS). Secondary outcomes include foot function (according to the Foot Function Index) at 6, 12 and 26 weeks, recovery (7-point Likert) at 6, 12 and 26 weeks, pain at rest and during activity (NRS) at 6 and 26 weeks and cost-effectiveness of the intervention at 26-weeks. Measurements will take place at baseline and at, 2, 4, 6, 12 and 26 weeks of follow-up. DISCUSSION: The treatment of plantar fasciopathy is a challenge for health care professionals. Orthotic devices are frequently applied, despite a lack of evidence of the effectiveness on patient reported outcome. The results of this randomized controlled trial will improve the evidence base for treating this troublesome condition in daily practice. TRIAL REGISTRATION: Dutch Trial Registration: NTR5346 . Date of registration: August 5(th) 2015.

Clinical efficacy and cost-effectiveness of bespoke and prefabricated foot orthoses for plantar heel pain: a prospective cohort study.

BACKGROUND: Plantar heel pain is a common reason for referral to podiatric practice, and one of the key interventions is the use of orthoses. The aim of the present study was to compare the clinical efficacy of bespoke, casted foot orthoses and prefabricated foot orthoses for plantar heel pain. METHODS: People with plantar heel pain were included if, following initial assessment, foot orthoses were indicated and participants received either bespoke, casted foot orthoses or prefabricated semi-rigid orthoses (Powerstep™). Clinical efficacy was assessed at eight weeks using the Manchester Foot Pain and Disability Questionnaire (MFPDQ). RESULTS: A total of 67 patients completed the trial and at baseline there were no appreciable differences in the two groups of patients in terms of the MFPDQ score; however, at eight weeks post-treatment both had significantly reduced foot pain and disability (both p < 0.0001). There was no significant difference in effectiveness between the bespoke or prefabricated orthoses. However, prefabricated devices were 38% cheaper per patient compared with the average costs of casted devices. CONCLUSION: For most patients with plantar heel pain, prefabricated semi-rigid insoles such as the Powerstep™ devices used in the present trial provide short-term benefit equivalent to that of bespoke, casted foot orthoses, but at considerably reduced costs.

Using a pilot study to establish experimental methods for inexpensive instrumented insoles used in dynamic skiing analysis.

Loss of balance leads to increased likelihood of falling for human locomotion. Determining the likelihood of falling for skiing locomotion is challenging because, unlike walking, normal locomotion is not clearly defined. One of the first learned styles of skiing is wedge style (WS). WS affords relatively easier balancing and speed control due to a wide base of support and greater resistance to forward movement, respectively. As skiers become more familiar with WS, their sensory, cognition, and actuation improve and they are able to apply more advanced styles, namely parallel style (PS), which requires refined balance. This paper studies the effects of WS and PS, on a single subject pilot study, and how they effect the likelihood of falling. A traditional laboratory setting was not suitable because of extreme difficulty and expense required to mimic the environment. Specially designed instrumented insoles were used to capture force data in a mountain environment.

Economic analysis of soft-heel casting for diabetic foot ulcer: prevention and treatment.

OBJECTIVE: To model the benefit of an innovative measure to manage patients with diabetes and a foot ulcer, or at high risk of ulceration, using a soft-heel casting, which can be applied by a podiatrist or other trained staff member and used in the hospital or community setting. METHOD: An audit of the patient outcomes associated with the casting at NHS Borders was undertaken for inpatients with ulcers. These data were combined with other published data and expert opinion to model the benefit of the casting for prevention and curative purposes compared to standard practice. Cost of healed and unhealed ulcers in various settings was estimated based on the treatment pathways adopted. RESULTS: The data from the economic model suggest that soft-heel castings could reduce the costs of managing these patients by approximately 10%; about £500 per inpatient and £425 per outpatient with an ulcer, and £205 per high-risk patient, when used for prevention. CONCLUSION: This cost-consequence analysis suggests the intervention could save about 10% of costs for managing patients with an active ulcer in inpatients or outpatients and offers potential savings if used as a preventive measure. Further studies are required to confirm the estimated clinical benefit and reduced resource use.