Cost-effectiveness of custom-made insoles versus usual care in patients with plantar heel pain in primary care: cost-effectiveness analysis of a randomised controlled trial.

OBJECTIVES: To evaluate the cost-effectiveness of custom-made insoles compared with general practitioner (GP)-led usual care after 26 weeks of follow-up in individuals with plantar heel pain (PHP) from a societal perspective. DESIGN: Cost-effectiveness analysis of a double-blinded randomised controlled trial. SETTING: General practice in the Netherlands. PARTICIPANTS: 116 participants with PHP for at least 2 weeks, aged 18-65 years and presenting to the GP. INTERVENTIONS: Participants were randomised to GP-led usual care (n=46) or referral to a podiatrist for treatment with a custom-made insole (n=70). Participant randomised to a sham insole (n=69) were excluded from this analysis. PRIMARY AND SECONDARY OUTCOMES: Outcomes comprised pain during rest and activity, and quality of life. Costs included healthcare and lost productivity costs. Statistical uncertainty was estimated using bootstrapping and presented using cost-effectiveness acceptability curves. RESULTS: Participants in the custom-made insole group experienced statistically significant more pain during activity at 26 weeks than participants in the usual care group (overall effect 1.06; 95% CI 0.36 to 1.75). There were no significant differences between groups in other outcomes. Total societal costs in the custom-made insole group were non-significantly higher than in the usual care group (mean difference €376; 95% CI -€1775 to €2038). The intervention with custom-made insoles was dominated by usual care by the GP (ie, more expensive and less effective) for pain during activity and quality of life outcomes. For the outcome pain at rest, the intervention was more expensive and more effective than usual care. However, the maximum probability of cost-effectiveness was only 0.59 at very high ceiling ratios. CONCLUSIONS: These findings show that that custom-made insoles are not cost-effective in comparison with GP-led usual care. Clinicians should be reserved in prescribing custom-made insoles for PHP as a primary intervention. TRIAL REGISTRATION NUMBER: NTR5346.

Custom insoles versus sham and GP-led usual care in patients with plantar heel pain: results of the STAP-study - a randomised controlled trial.

OBJECTIVES: To compare custom-made insoles to sham insoles and general practice (GP)-led usual care in terms of pain at rest and during activity at 12 weeks follow-up in individuals with plantar heel pain. METHODS: In this randomised clinical trial 185 patients aged 18 to 65 years, with a clinical diagnosis of plantar heel pain for at least 2 weeks, but no longer than 2 years were recruited. Patients were randomly allocated into three groups: (1) GP-led treatment, plus an information booklet with exercises (usual care; n=46), (2) referral to a podiatrist for treatment with a custom-made insole plus an information booklet with exercises (custom-made insole; n=70) and (3) referral to a podiatrist and treatment with a sham insole plus an information booklet with exercises (sham insole; n=69). As well as the primary outcome of pain severity (11-point Numerical Rating Scale) we used the Foot Function Index (0 to 100) as a secondary outcome. RESULTS: Of 185 randomised participants, 176 completed the 12-week follow-up. There was no difference in pain or function between the insole and the sham groups at 12 weeks. Participants in the GP-led usual care group reported less pain during activity at 12 weeks, (mean difference (MD) 0.94, 95% CI 0.23 to 1.65), less first step pain (MD 1.48, 95% CI 0.65 to 2.31), better function (MD 7.37, 95% CI 1.27 to 13.46) and higher recovery rates (RR 0.48, 95% CI 0.24 to 0.96) compared with participants in the custom insole group. CONCLUSIONS: Referral to a podiatrist for a custom-made insole does not lead to a better outcome compared to sham insoles or compared to GP-led usual care. TRIAL REGISTRATION NUMBER: NTR5346.

Incidence, prevalence, and management of plantar heel pain: a retrospective cohort study in Dutch primary care.

BACKGROUND: Plantar heel pain (PHP) is a common cause of foot complaints in general practice. However, information on the occurrence and practical management is scarce. AIM: The aim of this study was to determine the incidence and prevalence of PHP in Dutch primary care and to gain insight into the types of treatments provided to patients with PHP in primary care. DESIGN AND SETTING: A cohort study was conducted using a healthcare database containing the electronic general practice medical records of approximately 1.9 million patients throughout the Netherlands. METHOD: A search algorithm was defined and used to identify cases of PHP from January 2013 to December 2016. Descriptive statistics were used to obtain the incidence and prevalence. Data on the management of PHP were manually validated in a random sample of 1000 patients. RESULTS: The overall incidence of PHP was 3.83 cases (95% confidence interval [CI] = 3.77 to 3.89) per 1000 patient-years, the incidence in females was 4.64 (95% CI = 4.55 to 4.72), and 2.98 (95% CI = 2.91 to 3.05) in males. The overall prevalence of PHP was 0.4374% (95% CI = 0.4369 to 0.4378%). Incidence of PHP peaked in September and October of each calendar year. The most commonly applied strategies were a wait-and-see policy (18.0%, n = 168), use of non-steroidal anti-inflammatory drugs (NSAIDs) (19.9%, n = 186), referral to a paramedical podiatric specialist (19.7%, n = 184), and advice to wear insoles (16.4%, n = 153). Treatment strategies varied greatly among GPs. CONCLUSION: There was large variation in treatment strategies of GPs for patients with PHP. GPs should be aware of conflicting evidence for interventions, such as insoles, and focus more on exercises for which there is evidence for effectiveness.

Efficacy of foot orthoses for the treatment of plantar heel pain: a systematic review and meta-analysis.

BACKGROUND: Plantar heel pain (PHP) is common. Foot orthoses are often applied as treatment for PHP, even though there is little evidence to support this. OBJECTIVE: To investigate the effects of different orthoses on pain, function and self-reported recovery in patients with PHP and compare them with other conservative interventions. DESIGN: Systematic review and meta-analysis. DATA SOURCES: A systematic literature search was conducted in MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, Web of Science, CINAHL and Google Scholar up to January 2017. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: Randomised controlled trials comparing foot orthoses with a control (defined as no intervention, sham or other type of conservative treatment) reporting on pain, function or self-reported recovery in patients with PHP. RESULTS: Twenty studies investigating eight different types of foot orthoses were included in the review. Most studies were of high quality. Pooled data from six studies showed no difference between prefabricated orthoses and sham orthoses for pain at short term (mean difference (MD) of 0.26 (95% CI -0.09 to 0.60)). No difference was found between sham orthoses and custom orthoses for pain at short term (MD 0.22 (95% CI -0.05 to 0.50)), nor was there a difference between prefabricated orthoses and custom orthoses for pain at short term (MD 0.03 (95% CI -0.15 to 0.22)). For the majority of other interventions, no significant differences were found. CONCLUSIONS: Foot orthoses are not superior for improving pain and function compared with sham or other conservative treatment in patients with PHP. PROSPERO REGISTRATION NUMBER: CRD42015029659.

Interrelationships between Atopic Disorders in Children: A Meta-Analysis Based on ISAAC Questionnaires.

PURPOSE: To study the prevalence and interrelationship between asthma, allergic rhinitis and eczema using data obtained from ISAAC questionnaires. METHOD: The Medline, Pubmed Publisher, EMBASE, Google Scholar and the Cochrane Controlled Clinical Trials Register databases were systematically reviewed to evaluate epidemiological data of children with atopic disorders. To study these interrelationships, a new approach was used. Risk ratios were calculated, describing the risk of having two different atopic disorders when the child is known with one disorder. RESULTS: Included were 31 studies, covering a large number of surveyed children (n=1,430,329) in 102 countries. The calculated worldwide prevalence for asthma, eczema and allergic rhinitis is 12.00% (95% CI: 11.99-12.00), 7.88% (95% CI: 7.88-7.89) and 12.66% (95% CI: 12.65-12.67), respectively. The observed prevalence [1.17% (95% CI: 1.17-1.17)] of having all three diseases is 9.8 times higher than could be expected by chance. For children with asthma the calculated risk ratio of having the other two disorders is 5.41 (95% CI: 4.76-6.16), for children with eczema 4.24 (95% CI: 3.75-4.79), and for children with allergic rhinitis 6.20 (95% CI: 5.30-7.27). No studied confounders had a significant influence on these risk ratios. CONCLUSIONS: Only a minority of children suffers from all three atopic disorders, however this co-occurrence is significantly higher than could be expected by chance and supports a close relationship of these disorders in children. The data of this meta-analysis supports the hypothesis that there could be a fourth distinct group of children with all three disorders. Researchers and clinicians might need to consider these children as a separate group with distinct characteristics regarding severity, causes, treatment or prognosis.