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

Plantar Fasciitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00765843
• Other study ID #: ORT 067
• Status: Completed
• Phase: N/A
• First received: October 2, 2008
• Last updated: June 19, 2014
• Start date: October 2008
• Est. completion date: September 2012

Study information

• Verified date: June 2014
• Source: Rosalind Franklin University of Medicine and Science
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fasciitis, Plantar
• Plantar Fasciitis

Intervention

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

Locations

Country	Name	City	State
United States	Advocate Health Care	Chicago	Illinois
United States	Scholl Foot and Ankle Center	North Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Rosalind Franklin University of Medicine and Science	Advocate Health Care

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heel Pain	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	No

External Links

•   Center for Lower Extremity Ambulatory Research