Managing Pain in Patients With Plantar Fasciitis - A Blinded Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Plantar Fasciitis
- Sponsor
- Massachusetts General Hospital
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- PROMIS-Pain interference
- Status
- Terminated
- Last Updated
- 2 years ago
Overview
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.
Investigators
Soheil Ashkani Esfahani
Director, Foot and Ankle Research and Innovation Laboratory
Massachusetts General Hospital
Eligibility Criteria
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
Outcomes
Primary Outcomes
PROMIS-Pain interference
Time Frame: 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
PROMIS-Pain intensity
Time Frame: 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
Secondary Outcomes
- Foot and Ankle Outcome Score(Baseline, 2nd-, 6th-, and 12th-week follow-ups)
- Visual Analogue Scale for pain(Baseline, 2nd-, 6th-, and 12th-week follow-ups)