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

Sponsor:
Rosalind Franklin University of Medicine and Science
Collaborator:
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

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

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

  • Heel pain [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Heel Pain [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Heel Pain [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Heel Pain [ Time Frame: 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. Intervention: Device: orthoses
Device: orthoses
orthoses are provided for use in standardized shoes that all subjects receive Other Name: shoe insert
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. Intervention: Device: orthoses
Device: orthoses
orthoses are provided for use in standardized shoes that all subjects receive Other Name: shoe insert
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. Intervention: Device: orthoses
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.

 

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