title: Cryopreserved human amniotic membrane injection for plantar fasciitis: a randomized, controlled, double-blind pilot study.
abstract: BACKGROUND
  Treatment options for plantar fasciitis have resulted in varied patient outcomes. The aim of this study was to compare a novel treatment, cryopreserved human amniotic membrane (c-hAM), to a traditional treatment, corticosteroid. Our hypothesis was that c-hAM would be safe and comparable to corticosteroids for plantar fasciitis in regard to patient outcomes.
  
  
  METHODS
  A randomized, controlled, double-blind, single-center pilot study was completed. Patients were randomized into one of 2 treatment groups: c-hAM or corticosteroid. Patients received an injection at their initial baseline visit with an option for a second injection at their first 6-week follow-up. Total follow-up was obtained for 12 weeks after the most recent injection. The primary outcome measurement was the Foot Health Status Questionnaire (FHSQ). The secondary outcome measurements were the Visual Analog Scale (VAS) and verbally reported percentage improvement. Data were analyzed between groups for the 2 different cohorts (1 injection versus 2 injections). Twenty-three patients had complete follow-up. Fourteen were randomized to receive corticosteroid and 9 were randomized to receive c-hAM.
  
  
  RESULTS
  Three patients in each group received second injections. With the numbers available, the majority of outcome measurements showed no statistical difference between groups. The corticosteroid did, however, have greater FHSQ shoe fit improvement (P = .0244) at 6 weeks, FHSQ general health improvement (P = .0132) at 6 weeks, and verbally reported improvement (P = .041) at 12 weeks in the one-injection cohort. Cryopreserved hAM had greater FHSQ foot pain improvement (P = .0113) at 18 weeks in the 2-injection cohort.
  
  
  CONCLUSIONS
  Cryopreserved hAM injection may be safe and comparable to corticosteroid injection for treatment of plantar fasciitis. This is a pilot study and requires further investigation.
  
  
  METHODS
  Level I, prospective randomized trial.
authors.affiliation: Department of Orthopaedics, West Virginia University School of Medicine, Morgantown, WV, USA ahansel1@hsc.wvu.edu.
authors.forename: Andrew E
authors.initials: AE
authors.lastname: Hanselman
authors.affiliation: Department of Orthopaedics, West Virginia University School of Medicine, Morgantown, WV, USA.
authors.forename: John E
authors.initials: JE
authors.lastname: Tidwell
authors.affiliation: Department of Orthopaedics, West Virginia University School of Medicine, Morgantown, WV, USA.
authors.forename: Robert D
authors.initials: RD
authors.lastname: Santrock
mesh_terms: D000328:Adult; D000368:Aged; D000650:Amnion / Q000637:transplantation; D015925:Cryopreservation; D004311:Double-Blind Method; D036981:Fasciitis, Plantar / Q000628:therapy*; D005260:Female; D005938:Glucocorticoids / Q000627:therapeutic use; D006801:Humans; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D016896:Treatment Outcome
chemical_list: D005938:Glucocorticoids
keywords: amniotic membrane; corticosteroid; cryopreservation; heel pain; placental membranes; plantar fasciitis