Joost Peerbooms

104 Chapter 7 injections. The primary outcome parameter was pain. Secondary parameters were function and quality of life. METHODS Study design Peerbooms et al. 24 published the study design in the journal of BMC Musculoskeletal Disorders in 2010. Double-blind randomization was performed after patients were deemed eligible and provided informed consent. Patients were randomly allocated to the concentrated autologous platelet group (PRP group) or to the corticosteroid group (control group). A computer using block randomization of 10 patients was used to create a randomization schedule. Treatment assignments (placed in sequentially numbered opaque envelopes) were assigned by the trial managers who also arranged the facilities needed for the procedure. The investigator who assessed the outcomes was blinded to the treatment that the patient received. The treatment was given by another investigator who also prepared the two injections (J.C.P., H.M.S., T.G.). For both groups blood was drawn to make the groups as equal as possible. All patients with a plantar fasciitis who were admitted to one of the participating hospitals and met the inclusion criteria were asked to join the study. Plantar fasciitis was defined as pain at the point of the fascia plantaris origin at direct palpation. 6 All patients with plantar fasciitis were screened with X-ray of the calcaneus for bony abnormalities and to differentiate for subtalar arthritis. Sonography and magnetic resonance imaging were not used standardly. The Medical Ethical Committee of The Netherlands approved the study design, procedures, and informed consent. Study population The study was conducted at the Orthopaedic Departments of the HAGA Ziekenhuis Den Haag, Alrijne Ziekenhuis Leiden, Albert Schweitzer Ziekenhuis Dordrecht, Maastricht University Medical Centre and St. Elisabeth Ziekenhuis Tilburg (The Netherlands) between November 2008 and January 2015. J.C.P and T.G. were responsible for the data and safety monitoring. Inclusion criteria: patients aged > 18 years, with plantar fasciitis (at least 6 months duration), who failed conservative treatment are included. Patients were able to understand the informed consent. The FFI pain score in the morning should be higher than 5 (0-10 scale).