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

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  • 1 Department of Internal Medicine, Division of Metabolism, Endocrinology, and Diabetes, University of Michigan Medical School, Ann Arbor, MI.
  • | 2 Weil Foot and Ankle Orthopedic Institute, Chicago, IL.
  • | 3 Center for Lower Extremity Research, Dr. William M. Scholl College of Podiatric Medicine, Rosalind Franklin University of Medicine and Science, North Chicago, IL.
  • | 4 Department of Podiatric Surgery and Applied Biomechanics, Dr. William M. Scholl College of Podiatric Medicine, Rosalind Franklin University of Medicine and Science, North Chicago, IL.
  • | 5 Department of Surgery, Interdisciplinary Consortium on Advanced Motion Performance, Arizona Cancer Center, University of Arizona Center on Aging, Southern Arizona Limb Salvage Alliance, University of Arizona, College of Medicine, Tucson, AZ.
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Background

Up to 10% of people will experience heel pain. The purpose of this prospective, double-blind, randomized clinical trial was to compare custom foot orthoses (CFO), prefabricated foot orthoses (PFO), and sham insole treatment for plantar fasciitis.

Methods

Seventy-seven patients with plantar fasciitis for less than 1 year were included. Outcome measures included first step and end of day pain, Revised Foot Function Index short form (FFI-R), 36-Item Short Form Health Survey (SF-36), activity monitoring, balance, and gait analysis.

Results

The CFO group had significantly improved total FFI-R scores (77.4 versus 57.2; P = .03) without group differences for FFI-R pain, SF-36, and morning or evening pain. The PFO and CFO groups reported significantly lower morning and evening pain. For activity, the CFO group demonstrated significantly longer episodes of walking over the sham (P = .019) and PFO (P = .03) groups, with a 125% increase for CFOs, 22% PFOs, and 0.2% sham. Postural transition duration (P = .02) and balance (P = .05) improved for the CFO group. There were no gait differences. The CFO group reported significantly less stretching and ice use at 3 months.

Conclusions

The CFO group demonstrated 5.6-fold greater improvements in spontaneous physical activity versus the PFO and sham groups. All three groups improved in morning pain after treatment that included standardized athletic shoes, stretching, and ice. The CFO changes may have been moderated by decreased stretching and ice use after 3 months. These findings suggest that more objective measures, such as spontaneous physical activity improvement, may be more sensitive and specific for detecting improved weightbearing function than traditional clinical outcome measures, such as pain and disease-specific quality of life.

Corresponding author: James S. Wrobel, DPM, MS, Metabolism, Endocrinology, and Diabetes Division, University of Michigan Medical School, Domino's Farms, Lobby G, Suite 1500, 24 Frank Lloyd Wright Dr, Ann Arbor, MI 48105. (E-mail: jswrobel@med.umich.edu)