Foot Rehab + Minimalist Shoes for Plantar Fasciitis

(FRAMES Trial)

Overseen By Jennifer Xu, MS

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Virginia

Disqualifiers: Other injuries, Foot/ankle surgeries, others

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

Compensation: Varies

Number of Visits: 5

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if combining foot rehabilitation exercises with wearing minimalist shoes can better alleviate plantar fasciopathy (a type of foot pain) than exercises alone. Researchers seek to find out if this combination can reduce pain, improve foot strength, and enhance balance and walking. Participants will follow a home exercise plan, with some also gradually adjusting to minimalist shoes. This trial suits individuals experiencing heel pain that began gradually, has persisted for at least a month, and causes discomfort when taking their first steps in the morning. As an unphased trial, it offers participants the chance to contribute to innovative research that could lead to new treatment options for plantar fasciopathy.

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 would be best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this protocol is safe for individuals with plantar fasciopathy?

Research shows that using minimalist shoes along with foot exercises is generally safe for healthy individuals. Studies have found that these treatments can strengthen foot muscles without causing harm. Most people handle these exercises and shoes well, with no major side effects reported. Minimalist shoes have been successfully used for various foot and leg issues, proving to be a safe alternative to regular shoes. Therefore, those considering joining this trial can find reassurance in the safety record based on past research. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Foot Rehabilitation and Minimalist Shoes (FRAMES) approach for plantar fasciitis because it combines a home exercise program with the use of minimalist shoes, a novel strategy for this condition. Unlike standard treatments that typically involve orthotics, corticosteroid injections, or physical therapy alone, this method encourages natural foot movement and gradual adaptation to a new type of footwear. The minimalist shoes are designed to strengthen foot muscles and improve flexibility, potentially offering a more sustainable and holistic solution to managing and alleviating plantar fasciitis pain. This trial could reveal new insights into the benefits of minimalist footwear in conjunction with targeted exercises, offering a fresh perspective on managing this common foot condition.

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

Research has shown that foot exercises can significantly reduce pain and improve walking in individuals with plantar fasciitis. One study found that exercises to strengthen and stretch the foot eased pain and improved walking within three months. Additionally, physical therapy advice suggests that combining hands-on treatment with exercises can be very effective for this condition.

In this trial, one group will receive a home exercise program as a control. Another group, the Foot Rehabilitation And Minimalist Shoes (FRAMES) group, will receive both a pair of minimalist shoes and a home exercise program. Studies indicate that minimalist shoes can improve balance and strengthen foot muscles. Walking in these shoes might increase muscle activity, which could enhance foot function and reduce the risk of injury. Overall, combining foot exercises with wearing minimalist shoes might effectively manage plantar fasciitis. ^{6 7 8 9 10}

Who Is on the Research Team?

Jennifer Xu, MS

Principal Investigator

University of Virginia

Susan Saliba, PhD

Principal Investigator

University of Virginia

Are You a Good Fit for This Trial?

Adults aged 18-55 with plantar fasciopathy, experiencing morning heel pain for at least a month are eligible. They must have moderate pain levels and no other lower extremity injuries or surgeries in recent history. Those already in rehab for this condition or with prior minimalist shoe experience cannot participate.

Inclusion Criteria

My morning pain level is moderate, not mild or severe.

I have had heel pain for over a month that started gradually.

Exclusion Criteria

I have had foot or ankle fractures or surgeries in the past.

I have a current injury to my leg's muscles, bones, or nerves.

I have had injuries to my leg, not including the foot, in the last 3 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo a baseline clinical assessment to determine their level of pain and self-reported function using various patient-reported outcomes and functional measures.

1 day

1 visit (in-person)

Treatment

Participants perform foot rehabilitation exercises for 8 weeks. The intervention group also wears minimalist shoes.

8 weeks

2 visits (in-person), daily surveys (virtual)

Midpoint Check-in

Participants complete surveys and a phone call to discuss progress and any concerns.

1 day

1 phone call

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments similar to the baseline session.

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Foot Rehabilitation
• Minimalist Shoes

Trial Overview The trial is testing if foot rehabilitation exercises combined with wearing minimalist shoes over 8 weeks can reduce pain and improve function, strength, balance, and gait in adults with plantar fasciopathy better than exercises alone.

How Is the Trial Designed?

Group I: Foot Rehabilitation And Minimalist Shoes (FRAMES) Experimental Treatment 2 Interventions

The intervention group will receive a pair of minimalist shoes along with a home exercise program and a protocol that indicates how to slowly adjust to wearing the shoes.

Group II: Home Exercise Program (Control) Active Control 1 Intervention

The intervention group will receive a home exercise program.

Who Is Running the Clinical Trial?

University of Virginia

Lead Sponsor

Trials

802

Recruited

1,342,000+

Published Research Related to This Trial

In a study involving 13 patients with chronic Achilles tendinopathy, wearing rocker shoes significantly reduced the peak plantar flexion moment by 13% during both running and walking, which may help alleviate tendon loading and pain.

The use of rocker shoes did not change the activity levels of the triceps surae muscle, suggesting that these shoes can provide relief without requiring additional muscular effort from the calf muscles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rocker shoes reduce Achilles tendon load in running and walking in patients with chronic Achilles tendinopathy. Sobhani, S., Zwerver, J., van den Heuvel, E., et al.[2022]

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]

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 study involving 21 adults with chronic plantar fasciitis, both groups wearing different types of shoes (ultraflexible Nike Free 5.0 vs. conventional training shoes) reported significant pain improvements after a 12-week exercise regimen and a 6-month follow-up.

The group wearing the ultraflexible Nike shoes experienced lower pain levels earlier in the study compared to those in conventional shoes, suggesting that shoe flexibility may enhance the effectiveness of exercise-based therapies for plantar fasciitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Examining the degree of pain reduction using a multielement exercise model with a conventional training shoe versus an ultraflexible training shoe for treating plantar fasciitis. Ryan, M., Fraser, S., McDonald, K., et al.[2010]

A systematic review of nine studies found that wearing minimalist shoes can significantly increase intrinsic foot muscle strength by 9-57% and muscle size by 7.05-10.6% over a minimum intervention period of 2 weeks.

Minimalist shoes may serve as a convenient alternative to traditional physical therapy for enhancing foot muscle strength and size in healthy individuals, suggesting potential benefits for clinical populations as well.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of Minimalist Shoes on Plantar Intrinsic Foot Muscle Size and Strength: A Systematic Review. Xu, J., Saliba, SA., Jaffri, AH.[2023]

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]

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]

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]

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]

A study involving 40 patients with plantar fasciitis found that both a double air-cushioned shoe and physiotherapy combined with ESWT significantly improved foot function over time, with no significant differences in effectiveness between the two treatments.

The double air-cushioned shoe showed promise as a noninvasive alternative treatment for early-stage plantar fasciitis, as it led to a notable reduction in foot function index scores after 2 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a Double Air-Cushioned Shoe Compared with Physiotherapy in the Treatment of Plantar Fasciitis. Eun, SS., Chachan, S., Lee, SH.[2022]

Citations

1. 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.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06456944

Effect of Selected Rehabilitation Program in Patients With ... This study will be done to investigate the effect of the selected rehabilitation program for PF on plantar fascia thickness, clinical outcomes such as pain, ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/28142369/

Plantar Fasciitis: Will Physical Therapy Help My Foot Pain? The guidelines present evidence that strongly suggests a combination of manual therapy and rehabilitative exercises to help patients with this foot condition.

4. jfootankleres.biomedcentral.com jfootankleres.biomedcentral.com/articles/10.1186/s13047-023-00668-2

Development of a foot and ankle strengthening program for ... Seven of 9 (78%) exercises achieved consensus. The exercises that did not achieve consensus were heel raise seated with digits dorsiflexed (67%) ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1466853X1630075X

Strength training for plantar fasciitis and the intrinsic foot ... The aim was to critically evaluate the literature investigating strength training interventions in the treatment of plantar fasciitis and improving intrinsic ...

6. 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 ...

7. withpower.com withpower.com/trial/phase-fasciitis-10-2023-6202f

Foot Rehab + Minimalist Shoes for Plantar Fasciitis Research suggests that using minimalist shoes and foot rehabilitation exercises is generally safe for healthy individuals, as they can increase foot muscle ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12103103/

Minimalist Footwear in the Treatment and Rehabilitation of ... Minimalist footwear has emerged as an alternative to traditional footwear styles and advocated for the management of several foot and lower limb pathologies.

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

The effects of foot core exercises and minimalist footwear ... Foot exercises and minimalist shoes may be appropriate to increase foot strength and to induce biomechanical changes during dynamic tasks.

10. 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 ...