Clinical Trial: Efficacy of a Custom Temporary Foot Orthosis for Plantar Fasciitis Treatment

Study Status: Terminated
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Efficacy of a Custom Temporary Foot Orthosis for Plantar Fasciitis Treatment: A Randomized Controlled Trial.

Brief Summary: The aim of this randomized control trial is to identify the possible effectiveness of the temporary use of an inexpensive, custom-made plantar fascia orthotic (PFO).

Detailed Summary:

A. Background Plantar fasciitis is the most common foot complaint in America, affecting approximately 10% of people during their life time.9 It can be a painful and debilitating condition which appears in both sedentary and active populations. A survey performed by the Foot and Ankle Special Interest Group of the Orthopedic Section, APTA, found that 100% of therapists reported PF as the most common foot condition seen in their clinic. 9 Approximately one million patients visit physicians for the diagnosis and treatment of plantar fasciitis.10 Chronic plantar fasciitis, previously thought to be an inflammatory condition caused by repetitive microtearing of the plantar fascia, is now thought to be a degenerative condition.5 The plantar aponeurosis, or fascia, functions to provide static support of the longitudinal arch and dynamic shock absorption. It consists of 3 bands: lateral, medial, and central. The central band originates from the medial tubercle of the calcaneus and travels across the metatarsal heads to the phalanx of each toe.9 In the acute stage, pain is commonly localized to the origin of the medial and central bands at the plantar surface of the calcaneus.6 This pain is usually classified as a sharp or knife-like pain upon initial standing. The pain occurs after a period of non-weight bearing and is often the worst in the morning. Those in the chronic stages may report pain as being dull and achy. Pain in this stage may also extend beyond the medial tubercle, extending into the central and lateral bands. Pain at this stage does not usually subside after a few minutes of walking as seen in the acute phase.6 Many factors contribute to the development of plantar fasciitis. Anatomy, biomechanics and environment are factors which contribute to the development of this condition.6 Pes planus, pes cavus feet, limited dorsiflexion, tight Achilles tendon, tight hamstrings and obesity fall beneath anatomical causations.
Sponsor: University of Puget Sound

Current Primary Outcome: Foot Ankle Ability Measure (FAAM) to measure change from Baseline at 4 time frames [ Time Frame: Baseline, 2wks, 4 wks, 12 wks, 6 months ]

The FAAM has been shown to be a valid and reliable self-reported outcome measure of lower leg, ankle, and foot function of a range of musculoskeletal disorders in a physical therapy setting


Original Primary Outcome: Same as current

Current Secondary Outcome: Global Rating of Change (GRC) to measure perceived change at 4 follow-up periods [ Time Frame: 2 wks, 4 wks, 12 weeks, 6 months ]

The GRC is a 15 point scale used to measure patient's perceived change in their health status compared to baseline.


Original Secondary Outcome: Same as current

Information By: University of Puget Sound

Dates:
Date Received: June 17, 2013
Date Started: September 2013
Date Completion: December 2014
Last Updated: June 20, 2013
Last Verified: June 2013