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?

This trial examines whether walking on different types of terrain can strengthen foot muscles and reduce foot pain from plantar fasciitis. One group will train on natural surfaces like grass or dirt, while the other will train on hard surfaces like concrete, both wearing minimalist shoes. The trial seeks individuals who have experienced heel pain for over two months, which worsens after standing or resting but eases with light activity, and who haven't found relief with standard treatments. As an unphased trial, it offers participants the chance to contribute to innovative research that may lead to new treatment approaches for plantar fasciitis.

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.

What prior data suggests that terrain variation is safe for foot health?

Research has shown that walking or running on various surfaces can strengthen foot muscles and reduce foot pain. For example, individuals who run or walk on natural surfaces like grass often experience these benefits. One study found that most participants had less foot pain after running barefoot on grass.

While using different surfaces can be beneficial, it may also pose some risks. Some studies suggest that exercising on certain surfaces could lead to injuries, such as twisting an ankle. However, no specific safety issues have been identified with using minimalist shoes, like Vibram® Fivefingers, in these situations.

Overall, trying different surfaces appears promising, but it's important to exercise caution and pay attention to your body's signals. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial for plantar fasciitis because it explores how different terrains might impact recovery. Unlike traditional treatments, which often involve orthotics, physical therapy, or anti-inflammatory medications, this trial investigates the effects of training on natural terrain using minimalist shoes. The unique aspect here is the focus on surface variation—natural ground versus hardscapes—which could provide insights into how different environments affect foot mechanics and healing. This approach may reveal new, non-invasive strategies for managing plantar fasciitis, potentially offering a more holistic method for alleviating pain and improving foot function.

What evidence suggests that terrain variation is effective for plantar fasciitis?

Research shows that walking or running on various surfaces can strengthen foot muscles. Studies have found that stronger foot muscles can help reduce foot pain, including pain from conditions like plantar fasciitis. For example, after a few months of changing walking surfaces, participants may notice a decrease in discomfort. In this trial, participants in the Treatment Cohort will wear minimalist shoes on natural terrain, potentially enhancing foot muscle function, similar to a natural spring. Meanwhile, the Control Cohort will use the same minimalist shoes but train on hardscapes. This method could lead to less foot pain and improved overall foot health. ^{1 2 6 7 8}

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

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]

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]

Citations

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NCT05075005 | The Effects of Terrain Variation on Intrinsic ...

There have been many studies showing the correlation between improved intrinsic foot musculature strength and the reduction of foot pain and discomfort, but to ...

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Terrain Variation for Plantar Fasciitis

This study will examine the current understanding of terrain variation on foot musculature strength and its possible correlation with structural and functional ...

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Regional variations in plantar fascia elasticity and their ...

The aim of this study was to evaluate the relationship between plantar fascia (PF) elasticity, pain, visual analog scale (VAS) score, ...

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Terrain Variation Study - U F Orthopaedics & Sports Medicine

Terrain variation in a minimally shod foot should allow for more coordination and strengthening of the muscular and spring like systems within the foot, through ...

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sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0966636224000183

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Studies have shown that playing on AT may increase the risk of specific injuries, such as ankle injuries (e.g., ankle sprain), knee injuries (e.g., ACL injury), ...

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mdpi.com

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19 out of 20 patients had improved at week-6 (mean ± SD % change in pain score, −38.8 ± 21.5%) and at week-12 (median (IQR) % change in pain score, −58.3 (34.8) ...