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

34 Participants Needed

Trial Summary

What is the purpose of this trial?

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 individuals with plantar fasciopathy, compared to only performing foot rehabilitation exercises. The main questions it aims to answer are: * Will individuals with plantar fasciopathy be able to reduce their pain and improve their self-reported function by performing rehabilitation exercises and wearing minimalist shoes, compared to those only performing rehabilitation exercises? * Will individuals with plantar fasciopathy be able to increase their intrinsic foot muscle strength and size, their balance, and gait biomechanics by performing rehabilitation exercises and wearing minimalist shoes, compared to those only performing rehabilitation exercises? * What characteristics of individuals with plantar fasciopathy make them most suited to succeed in a protocol of performing rehabilitation exercises and wearing minimalist shoes? Participants will be asked to come into the lab at the start of the intervention and after 8 weeks, where the following will be assessed: * Patient-reported outcomes * Foot morphology * Intrinsic foot muscle strength * Balance * Gait biomechanics For the intervention, participants in both groups will perform the same rehabilitation exercises, including: * Massage to the bottom of the foot * Calf-raises * Calf and foot stretches

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 data supports the effectiveness of the treatment Foot Rehabilitation and Minimalist Shoes for Plantar Fasciitis?

Research shows that using minimalist shoes and foot exercises can help reduce pain and improve function in people with plantar fasciitis. Studies indicate that exercise-based therapies, including strength training and stretching, are effective in managing pain and enhancing foot strength. ^{1 2 3 4 5}

Is the combination of foot rehabilitation exercises and minimalist shoes safe for humans?

Research suggests that using minimalist shoes and foot rehabilitation exercises is generally safe for healthy individuals, as they can increase foot muscle strength and size. However, more research is needed to confirm safety and effectiveness in people with specific conditions like plantar fasciitis. ^{1 4 6 7 8}

How is the Foot Rehabilitation treatment for plantar fasciitis different from other treatments?

The Foot Rehabilitation treatment for plantar fasciitis is unique because it combines foot strengthening exercises with the use of minimalist shoes, which may help reduce pain more effectively than conventional shoes. This approach focuses on improving foot muscle strength and flexibility, which is less commonly emphasized in traditional treatments like rest, ice, or anti-inflammatory medications. ^{1 2 4 9 10}

Research Team

Jennifer Xu, MS

Principal Investigator

University of Virginia

Susan Saliba, PhD

Principal Investigator

University of Virginia

Eligibility Criteria

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

I am between 18 and 55 years old.

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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 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]

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]

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]

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]

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 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]

References

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

Strength training for plantar fasciitis and the intrinsic foot musculature: A systematic review. [2022]

2. England 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. [2010]

3. Scotland 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. [2017]

4. Switzerland 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. [2022]

5. Scotland pubmed.ncbi.nlm.nih.gov

Intensive physiotherapy versus home-based exercise and custom-made orthotic insoles in patients with plantar fasciitis: Pilot study. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Feasibility of the Archercise biofeedback device to strengthen foot musculature. [2021]

7. Germany pubmed.ncbi.nlm.nih.gov

The Effects of Minimalist Shoes on Plantar Intrinsic Foot Muscle Size and Strength: A Systematic Review. [2023]

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

Effectiveness of a Double Air-Cushioned Shoe Compared with Physiotherapy in the Treatment of Plantar Fasciitis. [2022]

9. Australia pubmed.ncbi.nlm.nih.gov

Rocker shoes reduce Achilles tendon load in running and walking in patients with chronic Achilles tendinopathy. [2022]

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

Outpatient vs Home Management Protocol Results for Plantar Fasciitis. [2022]