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OpenTrials
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NCT Number: NCT00765843

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

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.

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Key information

Conditions

Plantar Fasciitis Fasciitis Fasciitis, Plantar Foot Diseases Musculoskeletal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Advocate Health Care, Chicago, Illinois, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

orthoses

Device

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

Other names: shoe insert

Primary outcomes

  1. Heel Pain

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Rosalind Franklin University of Medicine and Science

Other

Collaborators

  • Wake Forest University Health Sciences

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Oct 3, 2008
Registry last updated
Jul 21, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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