A Trial of Custom Foot Orthoses for the Treatment of Plantar Heel Pain

Study Overview
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Brief Summary
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This is a study investigating treatment of plantar fasciitis (heel pain). Physicians commonly prescribe specialized orthoses (shoe inserts) to treat heel pain. This study will evaluate the reduction in heel pain associated with three types of orthoses. It is hypothesized that custom made orthoses will significantly decrease pain and improve foot function in comparison to prefabricated insoles and sham insoles.

Official Title
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A Randomized Controlled Trial of Custom Foot Orthoses for the Treatment of Plantar Heel Pain

Conditions
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Plantar Fasciitis

Intervention / Treatment
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* Device: orthoses


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients will be included if they present for each of the following: Pain at plantar fascial attachment to calcaneal tubercle and/or pain distal from tubercle along plantar fascial band Typical post-static dyskinesia. Pain first steps in morning or when getting up after being seated for a period of time Patients will be ambulatory with an age range of 18-75 with plantar heel pain present for no more than one year. They will not have previous injection within 6 months or currently use prescription custom foot orthoses. Patient history, exam, x-rays, and ultrasound will rule out other etiologies of heel pain including proximal or local nerve entrapment, arthritis, bone cyst or tumor, or stress fracture. Since most patients will likely self-treat this condition prior to seeking care, the investigators will allow a washout period (appendix) and acetaminophen rescue analgesia provision. Exclusion Criteria: Proximal musculoskeletal pathology (i.e., knee or hip arthritis, sciatica secondary to back pathology, significant limb length discrepancy. Use of gait assistive devices (crutches, canes, walkers). Inability to wear supportive closed toed shoes. Lack of range motion at the first metatarsophalangeal joint or subtalar joint.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Factorial Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: custom foot orthoses<br>Subjects will receive custom fabricated orthoses created from casts of the feet and according to individualized prescriptions. These orthoses are to be used in the standardized shoes provided to all subjects in the study. | Device: orthoses<br>* orthoses are provided for use in standardized shoes that all subjects receive<br>* Other names: shoe insert;|
| Active Comparator: pre-fabricated orthoses<br>Subjects will be provided pre-fabricated (non-customized) orthoses. These orthoses are to be used in the standardized shoes provided to all subjects in the study. for use in their shoes. | Device: orthoses<br>* orthoses are provided for use in standardized shoes that all subjects receive<br>* Other names: shoe insert;|
| Sham Comparator: sham insoles<br>Subjects will receive sham orthoses that are soft and pliable, but not designed to relieve pain. These orthoses are to be used in the standardized shoes provided to all subjects in the study. | Device: orthoses<br>* orthoses are provided for use in standardized shoes that all subjects receive<br>* Other names: shoe insert;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heel Pain | Overall foot pain as determined by the Foot Function Index-Revised (FFI-R) survey. Foot pain is assessed by answering 11 questions regarding foot pain experienced over the past week. Scores may range from 11 to 66. Higher scores are indicative of greater foot pain. | baseline, one month and three months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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heel pain