Foot Rehab + Minimalist Shoes for Plantar Fasciitis
(FRAMES Trial)
Recruiting in Palo Alto (17 mi)
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Virginia
Disqualifiers: Other injuries, Foot/ankle surgeries, others
No Placebo Group
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.
12345Is 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.
14678How 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.
124910Eligibility 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.
+2 more
Trial 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)
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Foot Rehabilitation And Minimalist Shoes (FRAMES)Experimental Treatment2 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 Control1 Intervention
The intervention group will receive a home exercise program.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of VirginiaCharlottesville, VA
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Who Is Running the Clinical Trial?
University of VirginiaLead Sponsor
References
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.
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]Plantar fasciitis is a common injury to the plantar aponeurosis, manifesting as pain surrounding its proximal insertion at the medial calcaneal tubercle. Pain is typically worse in the morning when getting out of bed, and may subside after the tissue is sufficiently warmed up. For running-based athletes and individuals who spend prolonged periods of time on their feet at work, plantar fasciitis may become recalcitrant to conservative treatments such as ice, rest, and anti-inflammatory medication. Exercise-based therapies have received only limited attention in the literature for this common problem, yet they are becoming increasingly validated for pain relief and positive tissue remodeling at other sites of similar soft-tissue overuse injury. This study reports on pain outcomes in individuals experiencing chronic plantar fasciitis while wearing a shoe with an ultraflexible midsole (Nike Free 5.0) (FREE) versus a conventional training (CON) shoe in a 12-week multielement exercise regimen, and after a 6-month follow-up. Adults with >or= 6-month history of painful heel pain were recruited and randomly assigned to wear 1 of the 2 shoes. All subjects completed the same exercise protocol. A visual analogue scale item tracked peak pain in the preceding 24 hours taken at baseline, 6- and 12-week points, and at the 6-month follow-up. Twenty-one subjects completed the program (9 FREE; 12 CON). Both groups reported significant improvements in pain by the 6-month follow-up, and the FREE group reported an overall reduced level of pain throughout the study as a result of lower mean pain scores at the midpoint and post-test compared with the CON group. The exercise regimen employed in this study appears to reduce pain associated with chronic plantar fasciitis, and in doing so, the Nike 5.0 shoe may result in reductions in pain earlier than conventional running shoes.
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.
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.
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.
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.
The Effects of Minimalist Shoes on Plantar Intrinsic Foot Muscle Size and Strength: A Systematic Review. [2023]Minimalist shoes are proposed to prevent injury and enhance performance by strengthening intrinsic foot muscles, yet there is little consensus on the effectiveness of minimalist shoes in increasing muscle strength or size. This systematic review assesses using minimalist shoes as an intervention on changes in plantar intrinsic foot muscle size and strength. PubMed, CINHAL, Scopus, and SPORT Discus were systematically searched for articles from January 2000 to March 2022. Studies were included if they had an intervention of at least 2 weeks with a control group and examined the effect of minimalist shoes on plantar intrinsic foot strength or size (either volume, cross-sectional area, or thickness). Nine studies were included. There were significant increases and percent changes in foot muscle strength, volume, cross-sectional area, and thickness. Strength increased between 9-57%, and size increased between 7.05-10.6%. Minimalist shoes may effectively increase intrinsic foot muscle size and strength in healthy individuals, and they may also be more convenient than implementing time-intensive physical therapy programs. Future research is needed to explore using minimalist shoes as an intervention in clinical populations who would benefit from increased IFM strength and function. It will also be vital to improve upon IFM assessment methods.
Effectiveness of a Double Air-Cushioned Shoe Compared with Physiotherapy in the Treatment of Plantar Fasciitis. [2022]This study was aimed at comparing the plantar fasciitis treatment effect of a double air-cushioned shoe to that of physiotherapy combined with ESWT.
Rocker shoes reduce Achilles tendon load in running and walking in patients with chronic Achilles tendinopathy. [2022]Relative rest and pain relief play an important role in the management of Achilles tendinopathy, and might be achieved by reducing the load on the Achilles tendon. Previous studies have provided evidence that rocker shoes are able to decrease the ankle internal plantar flexion moment in healthy runners during walking and running. Since plantar flexion moment is related to the Achilles tendon loading, rocker shoes might be considered in the conservative management of Achilles tendinopathy. Therefore, the aim of this study was to investigate the biomechanics of running and walking in a group of patients with Achilles tendinopathy wearing standard shoes versus rocker shoes.
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.