Minimal Shoes and Exercises for Plantar Fasciitis

(NAPA Trial)

Overseen By Irene Davis, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of South Florida

Disqualifiers: Diabetes, Gout, Arthritis, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 6 months

138 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether minimal shoes and foot exercises can improve foot health for those with plantar fasciitis. Researchers aim to determine if these interventions reduce pain and enhance physical function compared to traditional supportive shoes and orthotics. Participants will be divided into two groups: one using minimal footwear with exercises, and the other using supportive footwear with orthotics. Individuals who have experienced plantar fasciitis for at least six months and suffer from heel or arch pain during daily activities may be suitable for this trial. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to early-stage treatment evaluation.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It mainly focuses on footwear and exercises for plantar fasciitis.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that using minimalist shoes and doing foot exercises is generally safe. Studies indicate that these methods can strengthen foot muscles and may help reduce pain and improve foot function. Users of minimalist shoes have experienced better toe strength and increased foot muscle size. These benefits come with few reports of serious negative effects, indicating that most people handle these treatments well. Overall, evidence suggests that minimalist shoes and exercises are well-tolerated and offer a promising way to ease the symptoms of plantar fasciitis (heel pain). ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the new approach to treating plantar fasciitis because it uses minimal footwear combined with foot exercises. Unlike the standard supportive footwear and orthotics, which focus on providing external support, this new treatment encourages foot strengthening. The minimal footwear design allows for natural foot movement, promoting muscle strengthening beyond the exercise program. This could potentially address the root cause of weakening from long-term reliance on supportive shoes, offering a more sustainable solution.

What evidence suggests that this trial's treatments could be effective for plantar fasciitis?

Research has shown that wearing minimal footwear and doing foot exercises can greatly improve foot strength. One study found that wearing minimal shoes daily increased foot strength by about 57.4% over six months. Another study discovered that using minimalist shoes along with foot exercises strengthened toes and reduced pain in the inner foot. In this trial, participants in the "Minimal Footwear (Vivobarefoot)" arm will use these shoes and exercises to potentially help with plantar fasciitis, a common foot pain condition, and improve walking. Meanwhile, the "Supportive Footwear" arm will involve standard care with supportive shoes and foot orthoses. Overall, evidence suggests that minimal footwear and exercises can benefit foot pain management and improve foot function. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for aging adults who've had active plantar fasciitis for at least 6 months and experience heel or arch pain in the morning, with prolonged standing or walking. Participants should be able to stand and walk for 10 minutes with minimal pain.

Inclusion Criteria

I have had plantar fasciitis for at least 6 months.

I experience pain in my heel or arch when I take my first steps in the morning.

I experience heel or arch pain after standing for more than 15 minutes.

Exclusion Criteria

Used foot orthoses less than 3 months before start date of study

I have a condition like diabetes, gout, arthritis, or neuropathy.

I have worn minimal shoes before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized into two groups: one receiving minimal shoes and foot exercises, and the other receiving supportive shoes and orthotics.

6 months

Regular visits for monitoring and assessment

Follow-up

Participants are monitored for pain, physical function, and recurrence of plantar fasciitis.

6 months

Follow-up assessments at 3, 6, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Foot Exercises and Minimal Footwear

Trial Overview The study compares two approaches: one group will use minimal shoes combined with foot strengthening and flexibility exercises; the other will wear supportive footwear with orthotic devices and do flexibility exercises. Their step count and improvements in pain and function are monitored.

How Is the Trial Designed?

Group I: Minimal Footwear (Vivobarefoot) Experimental Treatment 1 Intervention

The experimental intervention involves the combination of foot strengthening/stretching and minimal footwear to promote the foot strengthening beyond the exercise program to mitigate weakening from chronic support.

Group II: Supportive Footwear Active Control 1 Intervention

The control intervention is considered the standard of care and involves combination of foot stretching and the addition of supportive shoes and foot orthoses.

Who Is Running the Clinical Trial?

University of South Florida

Lead Sponsor

Trials

433

Recruited

198,000+

University of Hartford

Collaborator

Trials

15

Recruited

600+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

A combination of custom insoles and minimalist flexible shoes significantly reduced pain and improved foot function in women with plantar fasciitis over a six-month period, compared to using minimalist shoes alone.

Participants using the custom insoles showed greater improvements in pain levels, foot health, and walking ability, indicating that this combined treatment is more effective for managing plantar fasciitis than minimalist shoes by themselves.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Short and Long-Term Therapeutic Treatment with Insoles and Shoes on Pain, Function, and Plantar Load Parameters of Women with Plantar Fasciitis: A Randomized Controlled Trial. Ribeiro, AP., João, SMA.[2022]

In a study involving 83 patients with plantar fasciitis, all three treatment groups (Foot Exercise, Foot and Hip Exercise, and Stretching Alone) showed significant improvements in pain and function after eight weeks, indicating that various exercise protocols can effectively alleviate symptoms.

No significant differences were found between the groups, suggesting that both stretching and strengthening exercises are beneficial for improving pain and stability in patients with plantar fasciitis, regardless of the specific focus of the exercise regimen.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of stretching with and without muscle strengthening exercises for the foot and hip in patients with plantar fasciitis: A randomized controlled single-blind clinical trial. Kamonseki, DH., Gonçalves, GA., Yi, LC., et al.[2017]

In a study of 140 patients with plantar fasciitis, plantar fascia stretching exercises led to the most significant improvement in heel pain and disability after 12 months, as measured by the Foot Function Index (FFI) and Foot and Ankle Disability Index (FADI).

Other treatments, such as heat application and silicone heel pads, also showed benefits, but were less effective than stretching exercises, highlighting the importance of targeted physical therapy in managing plantar fasciitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing the Role of Different Treatment Modalities for Plantar Fasciitis: A Double Blind Randomized Controlled Trial. Gupta, R., Malhotra, A., Masih, GD., et al.[2022]

A study involving 44 participants with plantar fasciitis found that extracorporeal shockwave therapy (ESWT) combined with usual care did not significantly improve functional ability compared to usual care alone over three months.

While both groups showed improvements in foot function and walking speed, the ESWT group had a slight increase in walking cadence, but overall, ESWT did not provide additional benefits in enhancing foot function or walking performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Extracorporeal shockwave therapy in the management of plantar fasciitis: A randomized controlled trial. Cinar, E., Saxena, S., Akkurt, HE., et al.[2021]

A study involving 53 feet from 47 patients with plantar fasciitis showed that a combined treatment of stretching, strengthening exercises, and myofascial release techniques was more effective than a home program focused only on stretching and strengthening.

Patients receiving the supervised outpatient treatment experienced significantly greater improvements in pain, flexibility, balance, and overall foot function compared to those who followed the home rehabilitation program, indicating the benefits of hands-on therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outpatient vs Home Management Protocol Results for Plantar Fasciitis. Çil, ET., Şaylı, U., Subaşı, F.[2022]

In a study of 60 participants with unilateral plantar fasciopathy, those using custom foot orthoses in new athletic shoes experienced significantly less first-step pain after 12 weeks compared to those using new shoes alone or a sham insole.

The custom orthoses not only reduced first-step pain but also led to a decrease in plantar fascia thickness, indicating a potential mechanism for their effectiveness in treating this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Custom foot orthoses improve first-step pain in individuals with unilateral plantar fasciopathy: a pragmatic randomised controlled trial. Bishop, C., Thewlis, D., Hillier, S.[2023]

The Archercise device effectively provided real-time biofeedback, significantly improving foot location adherence and performance in foot exercises among 30 adults, indicating its potential to enhance intrinsic foot muscle strength.

Almost all participants (97%) found that the biofeedback from Archercise helped them perform the exercises correctly, suggesting that this device could be a valuable tool for preventing foot deformities and disabilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of the Archercise biofeedback device to strengthen foot musculature. Latey, PJ., Eisenhuth, J., McKay, MJ., et al.[2021]

Walking in minimalist footwear significantly increases foot muscle size and strength, showing similar effectiveness to dedicated foot strengthening exercises over an 8-week period with 57 runners participating.

Both interventions (minimalist shoe walking and foot strengthening exercises) led to measurable improvements in muscle size and strength, while the control group showed no changes, highlighting the importance of stimulating foot muscles to prevent injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Walking in Minimalist Shoes Is Effective for Strengthening Foot Muscles. Ridge, ST., Olsen, MT., Bruening, DA., et al.[2019]

Strength training interventions for plantar fasciitis show promise in reducing pain and improving function, although no significant changes in plantar fascia thickness were observed, based on a review of seven moderate to high-quality studies.

There is limited evidence on the effectiveness of specific exercises, such as toe flexion against resistance and minimalist running shoes, for enhancing intrinsic foot muscle strength, highlighting the need for standardized outcome measures in future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strength training for plantar fasciitis and the intrinsic foot musculature: A systematic review. Huffer, D., Hing, W., Newton, R., et al.[2022]

In a pilot study involving 39 participants with plantar fasciitis, all three treatment programs (intensive physiotherapy, home-based exercise, and insoles) showed moderate improvements in pain and function after 6 weeks, indicating that each approach is clinically applicable and well-accepted by patients.

Despite the improvements, there were no significant differences in outcomes between the groups, suggesting that insoles can be effective on their own or in combination with other treatments, particularly for patients with limited ankle dorsiflexion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intensive physiotherapy versus home-based exercise and custom-made orthotic insoles in patients with plantar fasciitis: Pilot study. Yildiz, S., Sumer, E., Zengin, HY., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05834491

A Novel Approach to Plantar Fasciitis in the Aging Population The goal of this study is to determine whether improving foot strength through foot exercises and minimal footwear can provide improved outcomes over the ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06106958

Effects of Foot Rehabilitation And Minimalist Shoes on Pain ... The goal of this clinical trial is to compare the effects of 8 weeks of foot rehabilitation exercises in conjunction with wearing minimalist shoes in ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0268003324002493

The effects of foot core exercises and minimalist footwear ... From meta-analyses, minimalist shoes lead to greater strength of toes 2 to 5 (confidence interval = 0.02 to 0.76), and foot exercises resulted in lower medial ...

4. nature.com nature.com/articles/s41598-021-98070-0

Daily activity in minimal footwear increases foot strength This study shows that foot strength increases by, on average, 57.4% (p < 0.001) after six months of daily activity in minimal footwear.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6960082/

Effects of Strengthening and Stretching Exercises on the ... In conclusion, both the strengthening and stretching exercise programs could reduce the pain and improve gait performance in patients with PF within 3 months.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9648311/

Impact of routine footwear on foot health: A study on plantar ... About 94% of the participants' experience heel pain while taking the first few steps in the morning and 92.1% feel pain in their heels after ...

7. mdpi.com mdpi.com/2077-0383/14/21/7629

Effects of Barefoot and Minimalist Footwear Strength- ... Most interventions led to significant improvements in intrinsic and extrinsic foot muscle volume, medial arch function, toe flexor strength, and neuromuscular ...

8. withpower.com withpower.com/trial/phase-3-fasciitis-4-2023-ab4b3

Minimal Shoes and Exercises for Plantar Fasciitis Research suggests that using minimalist shoes and foot exercises is generally safe for strengthening foot muscles and may help reduce pain and improve function ...