About this trial
Modern footwear has been implicated as a contributor to foot pathology and changes in the biomechanics of gait. In addition to footwear, the investigators propose that the lack of terrain variation may directly contribute to the development of common foot pathologies, resulting from decreased intrinsic foot muscle function. This study will examine the current understanding of terrain variation on foot musculature strength and its possible correlation with structural and functional changes within the foot.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Patients presenting to the University of Florida Orthopaedics and Sports Medicine Institute with pain on the plantar medial or central heel for greater than 60 days with the following features
Pain upon palpation, or insidious pain onset
Pain accentuated after long periods of weight bearing activities or after periods of rest
A reduction in pain following light activities (McPoil et al., 2008)
Disqualifiers
History of lower leg or foot surgery, hindfoot trauma or fracture of the affected limb within the previous year.
Diagnosis of diabetic neuropathy, fibromyalgia, neurological disease, Achilles tendinopathy, metatarsalgia, tarsal tunnel syndrome or heel pad syndrome
Body Mass Index (BMI) > 35
Currently taking or applying any anti-inflammatory medication or medication to control nerve pathology, prescription or over the counter
Trial design
Parallel
Treatments tested in this trial
Treatment Cohort
Other interventionSubjects will walk on a specified University of Florida Natural Area Teaching Laboratory's (NATL) nature trail for approximately 30 minutes, three times per week for 8 weeks while wearing the minimalist shoes provided by the study team. Time, distance, and GPS walking route will be recorded utilizing the MapMyRun smartphone application, which is free to download and easy to use. The study team will assist each subject with downloading the application onto their smartphone and provide a brief training on app use at their pre-trial visit. Subjects will be asked to save each training session within the app to report to the study team upon completion of the 8-week training protocol. Subjects will be instructed to walk at a comfortable pace and to stop if they begin experiencing increased pain or discomfort.
Control Cohort
Other interventionSubjects will walk on hardscapes (e.g. sidewalk, asphalt, track, etc) for approximately 30 minutes, three times per week for 8 weeks while wearing the minimalist shoes provided by the study team. Similarly to the treatment group, subjects will be asked to utilize the MapMyRun smartphone application to record their training sessions. Subjects will be instructed to walk at a comfortable pace and to stop if they begin experiencing increased pain or discomfort.
Treatment groups
Trial outcomes
Primary outcomes
Revised Foot Function Index (FFI-R)
34 questions rated on a scale from 1 to 4, will be used to evaluate change in overall foot function, foot health, and quality of life at trial onset, at the end of each week throughout the training protocol and upon completion of the training protocol (total of 9 times).
Visual Analog Scale (VAS)
Zero millimeters on the VAS corresponds to 'no pain,' while 100 millimeters on the VAS corresponds to 'worst pain imaginable.' The participant will be asked to draw a vertical line perpendicular to the VAS line at the point that depicts their pain intensity on average throughout the week. The distance from the zero millimeter line to the participant's vertical mark will be measured to yield a score that ranges from 0 to 100. The change in these measurements is being assessed at the end of each week of the training protocol and upon completion of the training protocol (total of 9 times).
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