Role of insole material in treatment of plantar fasciitis: A randomized clinical trial

Background: In this randomized clinical trial, we compared the early effects of polyethylene (PE), polyurethane (PU), and Carbon Fiber insoles in the treatment of PF using a set of patient-reported outcomes. Methods: Patients were randomly allocated one of the three prefabricated insoles – Carbon Fiber (n = 14), PU (n = 14), or PE (n = 17) for regular use. Their response was recorded using PROMIS 3a (for pain intensity), PROMIS 4a (for pain interference), FAOS (Foot and Ankle Outcome Score), and VAS for pain at baseline, two, six, and twelve weeks. Results: The PROMIS pain intensity scores improved in both the Carbon Fiber and the PE groups starting at the 6th week (p = 0.04) and 2nd week (p = 0.002), respectively. PROMIS pain interference scores also showed positive trends in these two groups (p = 0.02, p = 0.004, respectively). Conclusion: Prefabricated Carbon Fiber and PE insoles showed significant pain-reducing effects in patients with PF. Levels of evidence: Level I, Randomized controlled trial.