Managing Pain in Patients With Plantar Fasciitis - A Blinded Randomized Controlled Trial

Mass General Brigham

Status: Terminated

Conditions: Plantar Fasciitis

Treatments: Device: Orthotic

Study type: Interventional

Funder types: Other

Identifiers

NCT06116799

2021P003250

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 45 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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45 participants in 3 patient groups

Carbon fiber insole

Experimental group

Description:

assigned carbon fiber insole

Treatment:

Device: Orthotic

Polyurethane

Active Comparator group

Description:

Assigned polyurethane insole

Treatment:

Device: Orthotic

Polyethylene

Active Comparator group

Description:

assigned polyethylene insole

Treatment:

Device: Orthotic