title: Orthosis-Shaped Sandals Are as Efficacious as In-Shoe Orthoses and Better than Flat Sandals for Plantar Heel Pain: A Randomized Control Trial.
abstract: OBJECTIVE
  To investigate efficacy of a contoured sandal being marketed for plantar heel pain with comparison to a flat flip-flop and contoured in-shoe insert/orthosis.
  
  
  METHODS
  150 volunteers aged 50 (SD: 12) years with plantar heel pain (>4 weeks) were enrolled after responding to advertisements and eligibility determined by telephone and at first visit. Participants were randomly allocated to receive commercially available contoured sandals (n = 49), flat flip-flops (n = 50) or over the counter, pre-fabricated full-length foot orthotics (n = 51). Primary outcomes were a 15-point Global Rating of Change scale (GROC: 1 = a very great deal worse, 15 = a very great deal better), 13 to 15 representing an improvement and the 20-item Lower Extremity Function Scale (LEFS) on which participants rate 20 common weight bearing activities and activities of daily living on a 5-point scale (0 = extreme difficulty, 4 = no difficulty). Secondary outcomes were worst level of heel pain in the preceding week, and the foot and ankle ability measure. Outcomes were collected blind to allocation. Analyses were done on an intention to treat basis with 12 weeks being the primary outcome time of interest.
  
  
  RESULTS
  The contoured sandal was 68% more likely to report improvement in terms of GROC compared to flat flip-flop. On the LEFS the contoured sandal was 61% more likely than flat flip-flop to report improvement. The secondary outcomes in the main reflected the primary outcomes, and there were no differences between contoured sandal and shoe insert.
  
  
  CONCLUSIONS
  Physicians can have confidence in supporting a patient's decision to wear contoured sandals or in-shoe orthoses as one of the first and simple strategies to manage their heel pain.
  
  
  BACKGROUND
  The Australian New Zealand Clinical Trials Registry ACTRN12612000463875.
authors.affiliation: University of Queensland, School of Health and Rehabilitation Sciences, St Lucia, Brisbane, Queensland, Australia.
authors.forename: Bill
authors.initials: B
authors.lastname: Vicenzino
authors.affiliation: University of Queensland, School of Health and Rehabilitation Sciences, St Lucia, Brisbane, Queensland, Australia.|Regis University, Rueckert-Hartman College for Health Professions, Denver, Colorado, United States of America.
authors.forename: Thomas G
authors.initials: TG
authors.lastname: McPoil
authors.affiliation: University of Queensland, School of Health and Rehabilitation Sciences, St Lucia, Brisbane, Queensland, Australia.
authors.forename: Aoife
authors.initials: A
authors.lastname: Stephenson
authors.affiliation: QIMR Berghofer Medical Research Institute, Brisbane, Herston, Queensland, Australia.
authors.forename: Sanjoy K
authors.initials: SK
authors.lastname: Paul
mesh_terms: D005260:Female; D005528:Foot / Q000503:physiopathology*; D061826:Foot Orthoses; D006801:Humans; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000503:physiopathology*; D012044:Regression Analysis; D012775:Shoes