Sufficient power;slowed enrollment pace;budget restraints

Plantar fasciitis (PF), a leading cause of persistent heel pain, results in almost a million physician visits annually. Conservative treatment is often the first line of management with insoles being frequently prescribed. While multiple studies have compared insoles based on the degree of customization to foot contour, the literature is lacking in data comparing insoles based on their material. 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.

Carbon fiber insoles (VKTRY, Milford, CT, USA) were initially designed to increase ground forces leading to a harder push off for faster running or higher jumping. To enable energy return, the insoles require extreme rigidity and therefore are composed of a full-length carbon-fiber base. The highly rigid construct of the carbon fiber can potentially benefit patients with plantar fasciitis by using these insoles in their own shoes, which could lead to more effective pain management, increased compliance, and improved patient outcomes. While this insole is currently being widely used by athletes, the application of this insole for PF patients has not been explored. Therefore, the aim of this study is to understand how patients respond to the these insoles compared to current standard orthotics (Superfeet Green, Superfeet Worldwide LLC. WA, USA and Aetrex L20, Aetrex Inc, NJ, USA) in a blinded randomized controlled trial.

Inclusion Criteria:

• Adult patients (over 18 years old) with plantar fasciitis
• Adults who are competent and able to consent on their own behalf
• Patients who are seen at MGH Boston, MGH Waltham and Newton Wellesley Hospital

Exclusion Criteria:

• Patients who received an injection in the last 6 months in their plantar fascia
• Patients who will need to be treated surgically
• Patients who are non-English speaking

All data acquired as specified by this protocol will be maintained and monitored by approved study staff. Approved study staff will be responsible for collecting the signed consent forms. All electronic data and subject information will be secured on non-networking password protected computers; all paperwork will be secured in locked filing cabinets. All electronic data and subject information will be secured in REDCap and will be secured on non-networking password protected computers to which only study staff will have access; all paper work will be secured in locked filing cabinets.