A Randomized Controlled Trial of Custom Foot Orthoses for the Treatment of Plantar Heel Pain - Full Text View

Sponsors and Collaborators:	Rosalind Franklin University of Medicine and Science Advocate Health Care
Information provided by:	Rosalind Franklin University of Medicine and Science
ClinicalTrials.gov Identifier:	NCT00765843

Purpose

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.

Condition	Intervention
Plantar Fasciitis	Device: orthoses

MedlinePlus related topics: Foot Health

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Factorial Assignment, Efficacy Study
Official Title:	A Randomized Controlled Trial of Custom Foot Orthoses for the Treatment of Plantar Heel Pain

Further study details as provided by Rosalind Franklin University of Medicine and Science:

Primary Outcome Measures:

Heel pain [ Time Frame: 1 month, 3 months, 6 months and 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

foot function [ Time Frame: 1 month, 3 months, 6 months and 12 months ] [ Designated as safety issue: No ]
Health related quality of life. [ Time Frame: 1 month, 3 months, 6 months and 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	300
Study Start Date:	October 2008

Arms	Assigned Interventions
custom foot orthoses: Active Comparator 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
pre-fabricated orthoses: Active Comparator 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
sham insoles: Sham Comparator 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

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00765843

Contacts

Contact: Ryan T Crews, MS	8475788437	ryan.crews@rosalindfranklin.edu
Contact: James S Wrobel, DMP, MS	847-578-8423	james.wrobel@rosalindfranklin.edu

Locations

United States, Illinois
Advocate Health Care	Recruiting
Chicago, Illinois, United States, 60618
Contact: Adam Fleischer, DPM, MPH 773-880-0320 adam.fleischer@rosalindfranklin.edu

Sponsors and Collaborators

Rosalind Franklin University of Medicine and Science

Advocate Health Care

More Information

Center for Lower Extremity Ambulatory Research This link exits the ClinicalTrials.gov site

Responsible Party:	Rosalind Franklin University of Medicine and Science ( James Wrobel, Principal Investigator )
Study ID Numbers:	ORT 067
Study First Received:	October 2, 2008
Last Updated:	November 4, 2008
ClinicalTrials.gov Identifier:	NCT00765843
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Fasciitis, Plantar
Musculoskeletal Diseases
Pain
Fasciitis
Foot Diseases

ClinicalTrials.gov processed this record on January 13, 2009