SLR - January 2021 - Ellen I. Roberts

Treating Heel Pain in Adults: A Randomized Clinical Trial of Hard Versus Modified Soft Custom Orthotics and Heel Pads

Reference: Seligman DAR, Dawson D, Streiner DL, Davis A. Treating Heel Pain in Adults: A Randomized Clinical Trial of Hard Versus Modified Soft Custom Orthotics and Heel Pads. Archives of Physical Medicine and Rehabilitation. 2020 Nov, doi:

Level of Evidence: 2

Scientific Literature Review

Reviewed By: Ellen I. Roberts, DPM
Residency Program: Saint Vincent Hospital – Worcester, MA

Podiatric Relevance: Affecting nearly ten percent of the population, heel pain associated with plantar fasciitis is one of the most common foot disorders podiatric physicians encounter. It is most prevalent in athletes, adults over 30 years of age with foot and ankle instability who have recently increased their daily weight-bearing activity, and older adults with declining muscular strength, causing over-pronation. This is a randomized clinical trial comparing the effectiveness of soft versus hard orthotics in the treatment of plantar fasciitis in adults. Level of function after orthotic use, cost and number of visits for orthotics, and efficacy of orthotics in relation to age were also compared in this study. 

Methods: A total of 44 participants from an orthotic clinic in a community-based hospital and a private orthotic clinic were interviewed by one trained research assistant. The research assistant was blinded to prevent possible bias during administration of the post-treatment questionnaire. Prior to randomization to the two treatment groups, patients were stratified by age (younger adults: ages 18-64 and older adults: 65+) in blocks of four to ensure that there were an equal number of participants receiving soft versus hard orthotics in each age group. Intervention for each group, hard versus soft custom orthotics, provided the same prescription: medial heel posting and medial longitudinal arch support. Baseline data collected included age, gender, and co-morbidities.  Participants completed three pre and post treatment questionnaires rating their level of pain, interference of pain with activity (Brief Pain Inventory), and general level of function (Late Life Function and Disability Instrument). Follow-up visits were conducted at six-week mark.

Results:  A reduction in pain intensity (P = 0.010) and pain interference (P < 0.001), but no change in function over time (P = 0.333) and no difference between the groups who received hard versus soft orthotics. Age had no effect on orthotic effectiveness. The average cost of soft orthotics was $163, versus $430 for hard orthotics. Soft orthotics were less expensive (P < 0.0001) and required fewer visits for fabrication (P < 0.0001).

Conclusions: This is the first randomized, controlled study that compares hard versus modified soft orthotics in treating heel pain and plantar fasciitis in younger versus older adults. The results were that "soft" orthotics were as effective as "hard" orthotics in reducing pain. There are several limitations to this study, especially the small sample size, with only 22 participants in each group, and several confounding variables. A long-term study investigating durability of the orthotic and efficacy over time are other potential aspects to consider in future studies.

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