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 F

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

Self-reported physical, affective and somatic effects of ecstasy (MDMA) use:An observational study of recreational users

Background: Assessments of the residual effects of 3,4-methylenedioxymethamphetamine (MDMA) are typically restricted to experimental studies. The current observational study aimed to investigate the immediate and delayed cognitive, affective and somatic effects of recreational MDMA and other drug use among adults. Method: Thirty-eight adults (26 males and 12 females) aged 19-55 years (mean age 32.1 years) who attended a private recreational event in the Netherlands participated in this study. Demographics and recreational drug use history was recorded at baseline. Participants were categorized a priori into groups based on self-reported drug use at the event and were classified as (1) MDMA and other drug use (N=13, MDMA group), (2) drug use other than MDMA (N=11, DRUGS group), and (3) alcohol only (N=14, ALCOHOL group). Participants completed a daily online survey for one week post drug use, and a past week mood assessment using the Brief Symptom Inventory (BSI) at day7 and day 30 post-drug use. Results: Compared to baseline, the MDMA group reported greater complaints one day post drug use, and some symptoms persisted up to four days. Compared to the MDMA group, the DRUGS group reported greater physical symptoms at one-day post drug ingestion, with some effects present at day 3 post-drug use. No past-week mood differences were detected between groups at day 7 or day 30. Conclusion: Those who consumed MDMA reported greater somatic complaints on day 1, and symptoms of reduced energy, increased fatigue, and weakness persisted up to four days post drug-ingestion