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).

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.