Minimal Shoes and Exercises for Plantar Fasciitis

(NAPA Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: University of South Florida

Disqualifiers: Diabetes, Gout, Arthritis, others

No Placebo Group

Prior Safety Data

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

The goal of this study is to determine whether improving foot strength through foot exercises and minimal footwear can provide improved outcomes over the short and long term. The main research question it aims to answer is: Can the minimal footwear intervention be used to improve the health of aging adults with plantar fasciitis?? Participants will be randomized into 2 groups. One group will receive minimal shoes and foot strengthening and foot flexibility exercises. The other group will receive supportive shoes, foot orthotic device and foot flexibility exercises. Participants' step count will also be monitored. Researchers will compare pain and physical function between the minimal footwear (MF) and the foot orthotic (FO) groups at each of the follow-up sessions.

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.

What data supports the effectiveness of the treatment Minimal Shoes and Exercises for Plantar Fasciitis?

Research suggests that using minimalist shoes and foot exercises can help reduce pain and improve function in people with plantar fasciitis. Strength training and flexibility exercises may also enhance foot muscle strength, which can contribute to better foot health and reduced symptoms. ^{1 2 3 4 5}

Is it safe to use 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 in people with plantar fasciitis. However, more standardized studies are needed to fully understand their safety and effectiveness. ^{1 2 6 7 8}

How is the treatment of foot exercises and minimal footwear for plantar fasciitis different from other treatments?

This treatment is unique because it focuses on strengthening the foot muscles and improving flexibility through exercises and wearing minimalist shoes, which may help reduce pain and improve function without relying on traditional methods like orthotics or anti-inflammatory drugs. ^{1 2 3 9 10}

Eligibility Criteria

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.

No special or vulnerable populations will be recruited.

Trial Timeline

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

Treatment Details

Interventions

• Foot Exercises and Minimal Footwear (Behavioural Intervention)

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.

Participant Groups

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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of South Flroida Tampa, FL

Who Is Running the Clinical Trial?

University of South Florida Lead Sponsor

University of Hartford Collaborator

National Institute on Aging (NIA) Collaborator

References

1. 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] Background and Objectives: Plantar fasciitis (PF) is a prevalent musculoskeletal disease, with inflammation at the origin of the plantar fascia, that affects sedentary people, particularly middle-aged women. Foot pain and functional limitations lead patients to seek treatment. Investigate the therapeutic effect of conservative treatment combining a custom insole with minimalist flexible shoes and the shoes alone in a gait-training protocol, in the short and long term, in women with PF. Materials and Methods: Design: A randomized, controlled, and single-blind trial.

2. England pubmed.ncbi.nlm.nih.gov

Strength training for plantar fasciitis and the intrinsic foot musculature: A systematic review. [2022] The aim was to critically evaluate the literature investigating strength training interventions in the treatment of plantar fasciitis and improving intrinsic foot musculature strength. A search of PubMed, CINHAL, Web of Science, SPORTSDiscus, EBSCO Academic Search Complete and PEDRO using the search terms plantar fasciitis, strength, strengthening, resistance training, intrinsic flexor foot, resistance training. Seven articles met the eligibility criteria. Methodological quality was assessed using the modified Downs and Black checklist. All articles showed moderate to high quality, however external validity was low. A comparison of the interventions highlights significant differences in strength training approaches to treating plantar fasciitis and improving intrinsic strength. It was not possible to identify the extent to which strengthening interventions for intrinsic musculature may benefit symptomatic or at risk populations to plantar fasciitis. There is limited external validity that foot exercises, toe flexion against resistance and minimalist running shoes may contribute to improved intrinsic foot musculature function. Despite no plantar fascia thickness changes being observed through high-load plantar fascia resistance training there are indications that it may aid in a reduction of pain and improvements in function. Further research should use standardised outcome measures to assess intrinsic foot musculature strength and plantar fasciitis symptoms.

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

Outpatient vs Home Management Protocol Results for Plantar Fasciitis. [2022] We compared the effectiveness of stretching and strengthening exercises combined with myofascial releasing and mobilization techniques to a stretching and strengthening only home program in plantar fasciitis (PF) management.

4. Scotland pubmed.ncbi.nlm.nih.gov

Extracorporeal shockwave therapy in the management of plantar fasciitis: A randomized controlled trial. [2021] This study aimed at estimating the extent to which a combination therapy of extracorporeal shockwave therapy (ESWT) with usual care (exercise and orthotic support) improve functional ability in the patient with plantar fasciitis when compared to usual care alone.

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] This prospective pilot study assessed the feasibility of comparing intensive physiotherapy group (IPG), home-based exercise (HBEG) group, and insole group (IG) to find the most effective treatment program for plantar fasciitis.

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

Custom foot orthoses improve first-step pain in individuals with unilateral plantar fasciopathy: a pragmatic randomised controlled trial. [2023] Foot orthoses are routinely used to treat plantar fasciopathy in clinical practice. However, minimal evidence exists as to the effect of both truly custom designed foot orthoses, as well as that of the shoe the foot orthoses are placed into. This study investigated the effect of wearing custom foot orthoses and new athletic footwear on first-step pain, average 24-h pain and plantar fascia thickness in people with unilateral plantar fasciopathy over 12 weeks.

7. England pubmed.ncbi.nlm.nih.gov

Feasibility of the Archercise biofeedback device to strengthen foot musculature. [2021] Foot muscle weakness can produce foot deformity, pain and disability. Toe flexor and foot arch exercises focused on intrinsic foot muscle strength and functional control may mitigate the progression of foot deformity and disability. Ensuring correct exercise technique is challenging due to the specificity of muscle activation required to complete some foot exercises. Biofeedback has been used to improve adherence, muscle activity and movement patterns. We investigated the feasibility of using a novel medical device, known as "Archercise", to provide real-time biofeedback of correct arch movement via pressure change in an inflatable bladder, and foot location adherence via sensors embedded in a footplate during four-foot exercises.

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

Walking in Minimalist Shoes Is Effective for Strengthening Foot Muscles. [2019] Weakness of foot muscles may contribute to a variety of loading-related injuries. Supportive footwear may contribute to intrinsic foot muscle weakness by reducing the muscles' role in locomotion (e.g., absorbing forces and controlling motion). Increased stimulus to the foot muscles can be provided through a variety of mechanisms, including minimalist footwear and directed exercise.

9. 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] To compare the effect of stretching with and without muscle strengthening of the foot alone or foot and hip on pain and function in patients with plantar fasciitis.

10. Switzerland pubmed.ncbi.nlm.nih.gov

Comparing the Role of Different Treatment Modalities for Plantar Fasciitis: A Double Blind Randomized Controlled Trial. [2022] Although many treatment modalities including rest, stretching, strengthening, change of shoes, arch supports, orthotics, night splints and anti-inflammatory agents have been advocated for plantar fasciitis, there is no report in the literature which compares the independent effectiveness of each treatment modality without the concomitant use of any other one.