Terrain Variation for Plantar Fasciitis

Overseen By Shea Herlihy, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Florida

Must not be taking: Anti-inflammatories, Nerve medications

Disqualifiers: Foot surgery, Diabetic neuropathy, BMI > 35, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 9 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of 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.

Will I have to stop taking my current medications?

Yes, if you are currently taking any anti-inflammatory medication or medication to control nerve issues, you will need to stop, as these are not allowed for participation in the trial.

How does the Terrain Variation treatment for plantar fasciitis differ from other treatments?

The Terrain Variation treatment for plantar fasciitis is unique because it focuses on altering the walking or running surface to address biomechanical factors, unlike traditional treatments that may focus on medication or physical therapy alone. This approach aims to modify the forces on the foot during movement, potentially reducing the overload on the plantar fascia. ^{1 2 3 4 5}

Who Is on the Research Team?

Antony Merendino, DPM

Principal Investigator

University of Florida

Are You a Good Fit for This Trial?

This trial is for adults over 18 in Gainesville who either have healthy feet or suffer from plantar fasciitis, experiencing heel pain that hasn't improved with standard treatments like stretching, medication, and supportive insoles for at least 6 months.

Inclusion Criteria

My pain worsens with activity or after resting.

I have had heel pain for more than 60 days.

My pain decreases after doing light activities.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants will utilize a minimalist shoe and follow a training protocol on either natural terrain or hardscapes

9 weeks

Weekly assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Terrain Variation

Trial Overview The study investigates how walking on different terrains affects foot muscle strength. It will compare the foot musculature of healthy individuals against those with plantar fasciitis to see if terrain variation influences foot structure and function.

How Is the Trial Designed?

Group I: Control Cohort Experimental Treatment 2 Interventions

Control Cohort: Will utilize the same minimalist shoe and follow the same training schedule as the treatment group, with the modification of training on hardscapes.

Group II: Treatment Cohort Active Control 2 Interventions

Treatment Cohort: Will utilize a minimalist shoe (Vibram® Fivefingers) and follow the training protocol described below for training on natural terrain.

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

Published Research Related to This Trial

In a study of 113 novice military conscripts over 10 weeks, 71 developed plantar fasciitis, with poorer movement quality and lower femoral anteversion angle identified as significant predictors of the condition.

Higher body mass index and stress levels increased the risk of plantar fasciitis, while prior physical exercise was associated with a reduced risk, highlighting the importance of individual characteristics in the development of this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of plantar fasciitis in Thai novice conscripts after 10-week military training: A prospective study. Harutaichun, P., Boonyong, S., Pensri, P.[2019]

The study found that factors such as increased time spent standing and walking on hard surfaces, as well as forefoot pronation, significantly increase the risk of developing plantar fasciitis among full-time employees in a manufacturing setting.

Implementing strategies like rotating shoes, using shoe orthoses, and modifying workstations to reduce time on hard surfaces can help prevent or treat plantar fasciitis effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk factors for plantar fasciitis among assembly plant workers. Werner, RA., Gell, N., Hartigan, A., et al.[2010]

A study involving 246 young male Army trainees revealed significant variability among clinicians when assessing foot types, indicating a lack of consistent definitions for flat and high-arched feet.

The findings highlight the urgent need for objective standards and quantitative methods to evaluate foot morphology, as current assessments can lead to inconsistent diagnoses and potential implications for injury risk in active individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Consistency of visual assessments of arch height among clinicians. Cowan, DN., Robinson, JR., Jones, BH., et al.[2017]

Female runners with a history of plantar fasciitis exhibited a significantly greater maximum instantaneous load rate when running, which may contribute to their injury risk.

These runners also had a lower arch index compared to healthy controls, suggesting that a flatter foot structure could be associated with a history of plantar fasciitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biomechanical and anatomic factors associated with a history of plantar fasciitis in female runners. Pohl, MB., Hamill, J., Davis, IS.[2022]

Athletes with symptomatic plantar fasciitis showed significant deficits in both dynamic and static range of motion, as well as reduced peak torque in the muscles of the posterior calf and foot, compared to healthy controls and unaffected feet.

The study involved 43 athletes with symptomatic plantar fasciitis and 45 control athletes, highlighting that strength and flexibility issues in the foot and calf muscles contribute to the condition, which is common among runners.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional biomechanical deficits in running athletes with plantar fasciitis. Kibler, WB., Goldberg, C., Chandler, TJ.[2022]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Predictors of plantar fasciitis in Thai novice conscripts after 10-week military training: A prospective study. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Risk factors for plantar fasciitis among assembly plant workers. [2010]

3. United States pubmed.ncbi.nlm.nih.gov

Consistency of visual assessments of arch height among clinicians. [2017]

4. United States pubmed.ncbi.nlm.nih.gov

Biomechanical and anatomic factors associated with a history of plantar fasciitis in female runners. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Functional biomechanical deficits in running athletes with plantar fasciitis. [2022]