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

Not Applicable

Terminated

• Conditions: Plantar Fasciitis
• Interventions: Device: Orthotic

• Registration Number: NCT06116799
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2022-04-01
• Primary Completion: 2023-05-06
• Study Completion: 2023-05-06
• Status Verified: 2023-10
• Study First Submitted: 2023-10-31
• Study First Submitted QC: 2023-10-31
• Last Update Submitted: 2023-10-31
• Study First Posted: 2023-11-03
• Last Update Posted: 2023-11-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Carbon fiber insole	Orthotic	assigned carbon fiber insole
Polyurethane	Orthotic	Assigned polyurethane insole
Polyethylene	Orthotic	assigned polyethylene insole

Primary Outcome Measures

Name	Time	Method
PROMIS-Pain intensity	Baseline, 2nd-, 6th-, and 12th-week follow-ups	assesses how much a person hurts. Patients are usually able to provide quantitative pain intensity estimates relatively quickly
PROMIS-Pain interference	Baseline, 2nd-, 6th-, and 12th-week follow-ups	measures the extent to which pain hinders an individual's engagement with physical, mental, cognitive, emotional, recreational, and social activities

Secondary Outcome Measures

Name	Time	Method
Foot and Ankle Outcome Score	Baseline, 2nd-, 6th-, and 12th-week follow-ups	a 42-item questionnaire with 5 subscales: pain (9 items), other symptoms (7 items), activities of daily living (ADL) (17 items), sports/recreation (5 items), and quality of life (4 items
Visual Analogue Scale for pain	Baseline, 2nd-, 6th-, and 12th-week follow-ups	A Visual Analogue Scale (VAS) is one of the pain rating scales

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States