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.

Autologous growth factor injections in chronic tendinopathy: a systematic review.

Chronic degenerative tendinopathies are frequent and difficult to treat. Tendon healing and regeneration may be improved by injecting autologous growth factors obtained from the patient's blood. Autologous growth factors can be injected with autologous whole blood or platelet-rich plasma (PRP). Electronic databases were searched for prospective clinical trials on treatment with autologous growth factors of patients with chronic tendinopathy. Chronic tendinopathy in this study included wrist extensors, flexors, plantar fasciopathy and patellar tendinopathy. Studies examining the treatment of other tendinopathies were not identified. The Physiotherapy Evidence Database score was used to examine the methodological quality of the assessment, and a qualitative analysis was performed with the levels of evidence. There are many proposed treatment options for chronic tendinopathy. Treatments in the form of injections with autologous whole blood or PRP are increasingly used in clinical practice. There are high expectations of these regenerative injections, and there is a clear need for effective conservative therapies. All studies showed that injections of autologous growth factors (whole blood and PRP) in patients with chronic tendinopathy had a significant impact on improving pain and/or function over time. However, only three studies using autologous whole blood had a high methodological quality assessment, and none of them showed any benefit of an autologous growth factor injection when compared with a control group. At present, there is strong evidence that the use of injections with autologous whole blood should not be recommended. There were no high-quality studies found on PRP treatment. There is limited evidence to support the use of injections with PRP in the management of chronic tendinopathy. There is growing interest in the working mechanisms of autologous growth factors. The amount and mixture of growth factors produced using different cell separating systems are largely unknown and it is also uncertain whether platelet activation prior to injection is necessary. These variables should be taken into account when starting clinical studies. A good experimental model for studying tendinopathy would be helpful for basic research. Future clinical studies using a proper control group, randomization, blinding and validated disease-specific outcome measures for pain and function are needed.