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

June 19, 2014 updated by: Adam Fleischer, Rosalind Franklin University of Medicine and Science

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

77

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60618
        • Advocate Health Care
      • North Chicago, Illinois, United States, 60064
        • Scholl Foot and Ankle Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Device: orthoses
orthoses are provided for use in standardized shoes that all subjects receive
Other Names:
  • shoe insert
Active Comparator: 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.
Device: orthoses
orthoses are provided for use in standardized shoes that all subjects receive
Other Names:
  • shoe insert
Sham Comparator: 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.
Device: orthoses
orthoses are provided for use in standardized shoes that all subjects receive
Other Names:
  • shoe insert

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heel Pain
Time Frame: baseline, one month and three months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rosalind Franklin University of Medicine and Science

Collaborators

Advocate Health Care

Investigators

  • Principal Investigator: Adam Fleischer, DPM, MPH, Center for Lower Extremity Ambulatory Research (CLEAR)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

October 2, 2008

First Submitted That Met QC Criteria

October 2, 2008

First Posted (Estimate)

October 3, 2008

Study Record Updates

Last Update Posted (Estimate)

July 21, 2014

Last Update Submitted That Met QC Criteria

June 19, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ORT 067

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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