ObjectivesTo 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.MethodsIn 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.ResultsOf 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.ConclusionsReferral 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 numberNTR5346.

PurposeTo study the prevalence and interrelationship between asthma, allergic rhinitis and eczema using data obtained from ISAAC questionnaires.MethodThe 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.ResultsIncluded 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.ConclusionsOnly 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.

BackgroundPlantar heel pain (PHP) is common. Foot orthoses are often applied as treatment for PHP, even though there is little evidence to support this.ObjectiveTo investigate the effects of different orthoses on pain, function and self-reported recovery in patients with PHP and compare them with other conservative interventions.DesignSystematic review and meta-analysis.Data sourcesA 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 studiesRandomised 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.ResultsTwenty 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.ConclusionsFoot orthoses are not superior for improving pain and function compared with sham or other conservative treatment in patients with PHP.PROSPERO registration numberCRD42015029659.

BackgroundPlantar heel pain (PHP) is a common cause of foot complaints in general practice. However, information on the occurrence and practical management is scarce.AimThe 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 settingA cohort study was conducted using a healthcare database containing the electronic general practice medical records of approximately 1.9 million patients throughout the Netherlands.MethodA 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.ResultsThe 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.ConclusionThere 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.

BackgroundPlantar 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/designThis 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.DiscussionThe 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 registrationDutch Trial Registration:NTR5346. Date of registration: August 5th 2015.

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ObjectivesTo 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.DesignCost-effectiveness analysis of a double-blinded randomised controlled trial.SettingGeneral practice in the Netherlands.Participants116 participants with PHP for at least 2 weeks, aged 18–65 years and presenting to the GP.InterventionsParticipants 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 outcomesOutcomes 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.ResultsParticipants 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.ConclusionsThese 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 numberNTR5346.

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