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

Completed · Not applicable · Has a placebo group

Conditions studied: Plantar Fasciitis

In brief

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.

Key facts

Study ID

NCT00765843

Run by

Rosalind Franklin University of Medicine and Science

People needed

77

Starts

2008-10-01

Expected to finish

2012-09-01

Last updated by the study team

2014-07-21

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Advocate Health Care — Chicago, Illinois, United States
• Scholl Foot and Ankle Center — North Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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