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

This study has been completed.
Sponsor:
Collaborator:
Advocate Health Care
Information provided by (Responsible Party):
Adam Fleischer, Rosalind Franklin University of Medicine and Science
ClinicalTrials.gov Identifier:
NCT00765843
First received: October 2, 2008
Last updated: June 19, 2014
Last verified: June 2014
  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

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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Heel Pain [ Time Frame: baseline, one month and three months ] [ Designated as safety issue: No ]
    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.


Enrollment: 77
Study Start Date: October 2008
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: shoe insert

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Illinois
Advocate Health Care
Chicago, Illinois, United States, 60618
Scholl Foot and Ankle Center
North Chicago, Illinois, United States, 60064
Sponsors and Collaborators
Rosalind Franklin University of Medicine and Science
Advocate Health Care
Investigators
Principal Investigator: Adam Fleischer, DPM, MPH Center for Lower Extremity Ambulatory Research (CLEAR)
  More Information

Additional Information:
No publications provided

Responsible Party: Adam Fleischer, Assistant Professor, Rosalind Franklin University of Medicine and Science
ClinicalTrials.gov Identifier: NCT00765843     History of Changes
Other Study ID Numbers: ORT 067
Study First Received: October 2, 2008
Results First Received: April 28, 2014
Last Updated: June 19, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Rosalind Franklin University of Medicine and Science:
heel pain

Additional relevant MeSH terms:
Fasciitis
Fasciitis, Plantar
Musculoskeletal Diseases
Foot Diseases

ClinicalTrials.gov processed this record on August 28, 2014