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

Not Applicable

Completed

• Conditions: Plantar Fasciitis

• Registration Number: NCT00765843
• Lead Sponsor: Rosalind Franklin University of Medicine and Science

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2008-10-02
• Study First Submitted QC: 2008-10-02
• Study First Posted: 2008-10-03
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Results First Submitted: 2014-04-28
• Status Verified: 2014-06
• Results First Submitted QC: 2014-06-19
• Last Update Submitted: 2014-06-19
• Results First Posted: 2014-07-21
• Last Update Posted: 2014-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Heel Pain	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.

Trial Locations

Locations (2)

Advocate Health Care; 🇺🇸 Chicago, Illinois, United States

Scholl Foot and Ankle Center; 🇺🇸 North Chicago, Illinois, United States