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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

77 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2012-09-30

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.

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Detailed Description

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Conditions

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Plantar Fasciitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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custom foot orthoses

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.

Group Type ACTIVE_COMPARATOR

orthoses

Intervention Type DEVICE

orthoses are provided for use in standardized shoes that all subjects receive

pre-fabricated orthoses

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.

Group Type ACTIVE_COMPARATOR

orthoses

Intervention Type DEVICE

orthoses are provided for use in standardized shoes that all subjects receive

sham insoles

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.

Group Type SHAM_COMPARATOR

orthoses

Intervention Type DEVICE

orthoses are provided for use in standardized shoes that all subjects receive

Interventions

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orthoses

orthoses are provided for use in standardized shoes that all subjects receive

Intervention Type DEVICE

Other Intervention Names

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shoe insert

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No