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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Plantar Fasciitis

Intervention / Treatment
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* Device: Orthotic


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 19 patients with plantar fasciitis will be allocated to carbon fiber insole group 19 patients with plantar fasciitis will be allocated to polyurethane insole group 19 patients with plantar fasciitis will be allocated to polyethylene insole group
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Carbon fiber insole<br>assigned carbon fiber insole | Device: Orthotic<br>* Arch support orthotic<br>|
| Active Comparator: Polyurethane<br>Assigned polyurethane insole | Device: Orthotic<br>* Arch support orthotic<br>|
| Active Comparator: Polyethylene<br>assigned polyethylene insole | Device: Orthotic<br>* Arch support orthotic<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Foot and Ankle Outcome Score | 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 | Baseline, 2nd-, 6th-, and 12th-week follow-ups | 
| Visual Analogue Scale for pain | A Visual Analogue Scale (VAS) is one of the pain rating scales | Baseline, 2nd-, 6th-, and 12th-week follow-ups |