Therapeutic Shoes for Plantar Fasciitis

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Texas Rio Grande Valley

Must not be taking: Oral anti-inflammatories

Disqualifiers: Plantar ulcer, Major foot deformities, Amputation, others

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

The research project aims to evaluate the effectiveness of OrthoFeet Hands-Free therapeutic shoes and prefabricated inserts in patients with foot pain.

Do I need to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot be engaged in any treatment for foot pain, including oral anti-inflammatories.

What data supports the effectiveness of the treatment OrthoFeet HandsFree Therapeutic Shoe for plantar fasciitis?

Research shows that using specialized shoes, like rocker sole shoes, and custom-made foot orthoses can be effective in treating plantar fasciitis. These types of footwear help by providing support and reducing strain on the foot, which may suggest that OrthoFeet therapeutic shoes could offer similar benefits.

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Is it safe to use therapeutic shoes for plantar fasciitis?

The research articles provided do not contain specific safety data for the therapeutic shoes mentioned, such as OrthoFeet HandsFree Therapeutic Shoe or its variants, in humans.

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How does the OrthoFeet HandsFree Therapeutic Shoe treatment differ from other treatments for plantar fasciitis?

The OrthoFeet HandsFree Therapeutic Shoe is unique because it offers a hands-free design that may provide continuous support and relief for plantar fasciitis, unlike traditional treatments that require specific shoes or orthotics. This can be particularly beneficial for maintaining foot support throughout the day, even when not wearing conventional shoes.

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Eligibility Criteria

This trial is for individuals who can consent, have normal foot sensation, and self-reported foot pain not currently under a treatment plan. It excludes those with swelling, ulcers, major foot deformities or amputations, cognitive impairments or depression, unstable medical conditions, decreased foot sensation, or those treating their foot pain.

Inclusion Criteria

Be able to give written, informed consent

In-tact protective sensation as determined using Semmes Weinstein monofilament

I am not currently following any doctor-prescribed treatment plans.

Exclusion Criteria

I have swelling.

I have an ulcer on the bottom of my foot.

I have significant foot deformities like charcot foot or high arches.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants wear OrthoFeet Hands-Free therapeutic shoes and prefabricated inserts for a 6-week intervention period

6 weeks

Baseline, 6 weeks, 12 weeks

Follow-up

Participants are monitored for improvements in foot pain, quality of life, and plantar pressure distribution

6 weeks

12 weeks

Participant Groups

The study tests the effectiveness of OrthoFeet HandsFree therapeutic shoes with inserts in reducing foot pain and pressure. Participants will use these specialized shoes to see if they help relieve discomfort associated with plantar fasciitis.

Group I: OrthoFeet shoe Experimental Treatment 1 Intervention

Patients wearing OrthoFeet shoes with standard inserts

Group II: Own Shoe Active Control 1 Intervention

Patients wearing their own appropriate shoes

OrthoFeet HandsFree Therapeutic Shoe is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as OrthoFeet Hands-Free Therapeutic Shoe for:

• Foot pain
• Plantar fasciitis
• Diabetes & Neuropathy
• Back pain
• Morton's Neuroma

🇪🇺 Approved in European Union as OrthoFeet Hands-Free Therapeutic Shoe for:

• Foot pain
• Plantar fasciitis
• Diabetes & Neuropathy
• Back pain
• Morton's Neuroma

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Hafizur Rahman Harlingen, TX

Who Is Running the Clinical Trial?

University of Texas Rio Grande Valley Lead Sponsor

References

1. France pubmed.ncbi.nlm.nih.gov

A comparison of two night ankle-foot orthoses used in the treatment of inferior heel pain: a preliminary investigation. [2012] Non-operative treatment for plantar fasciitis varies widely and includes the use of night ankle-foot orthoses (AFOs). This study compares the effectiveness of a posterior AFO, which dorsiflexes the foot, with an anterior AFO, which maintains the foot in a plantigrade position.

2. France pubmed.ncbi.nlm.nih.gov

Effect of different orthotic concepts as first line treatment of plantar fasciitis. [2022] Evaluation of the effectiveness of three different types of prefabricated foot orthotics in the treatment of plantar fasciitis.

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

Effectiveness of prefabricated and customized foot orthoses made from low-cost foam for noncomplicated plantar fasciitis: a randomized controlled trial. [2022] To evaluate the effectiveness of prefabricated and customized foot orthoses made from low-cost foam (ethylene vinyl acetate [EVA]) in plantar fasciitis.

4. Turkey pubmed.ncbi.nlm.nih.gov

[The effectiveness of dorsiflexion night splint added to conservative treatment for plantar fasciitis]. [2019] We evaluated the effectiveness and results of night splint applications for the treatment of plantar fasciitis.

5. England pubmed.ncbi.nlm.nih.gov

Evaluation of combined prescription of rocker sole shoes and custom-made foot orthoses for the treatment of plantar fasciitis. [2019] It is a routine practice to prescribe a combination of rocker shoes and custom-made foot orthoses for patients with plantar fasciitis. Recently, there has been a debate on this practice, and studies have shown that the individual prescription of rocker shoes or custom-made foot orthoses is effective in treating plantar fasciitis. The aim of this study was to evaluate and compare the immediate therapeutic effects of individually prescribed rocker sole shoes and custom-made foot orthoses, and a combined prescription of them on plantar fasciitis.

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

Effect of 3D Printing Individualized Ankle-Foot Orthosis on Plantar Biomechanics and Pain in Patients with Plantar Fasciitis: A Randomized Controlled Trial. [2020] BACKGROUND Traditional ankle-foot orthoses (AFOs) are not effective in treating plantar fasciitis, while customized 3-dimensional (3D) printed ankle-foot orthoses are effective in treating many ankle-foot diseases. This study investigated the effects of customized 3D printed AFOs on biomechanics and comfort of the plantar foot in plantar fasciitis. MATERIAL AND METHODS Sixty patients with bilateral plantar fasciitis aged 31-60 years participated in this study. At week 0, patients were randomly assigned into 2 groups: the control group consisting of those wearing separate shoes with prefabricated AFOs; and the experimental group consisting of those wearing a separate shoe and customized 3D-printed AFO. The Footscan® system recorded maximum pressure, maximum strength, and contact area of patients' hallux, toes 2-5, first to fifth metatarsal, midfoot, lateral heel, and midfoot heel at weeks 0 and 8. Patients used visual analogue scale scores at weeks 0 and 8 to assess overall comfort of foot orthosis, to determine the credibility and comfort of both orthopedic insole conditions. RESULTS At week 0, in the experimental group, peak pressure in the hallux and first metatarsal area was significantly higher than the control group (P

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

Use of orthotics with orthotic sandals versus the sole use of orthotics for plantar fasciitis: Randomised controlled trial. [2023] Plantar fasciitis (PF) affects around 10% of the population. Prefabricated orthotics with arch support has been shown to provide symptom relief in PF by decreasing the repetitive stress sustained by the plantar fascia. However, prefabricated orthotics are only effective when shoes are worn, meaning the foot may be left unsupported when it is impractical to wear shoes. Using orthotic sandals in conjunction with prefabricated orthotics may increase PF symptom relief, as they can be worn inside the home, extending the period in which the foot is supported.

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

Endoscopic plantar fascia release. [2017] Endoscopic release of the plantar fascia is becoming an increasingly popular alternative to open procedures for the treatment of chronic plantar fasciitis. Although most patients can be successfully treated with Achilles tendon stretching, orthoses, physical therapy and corticosteroid injections, a small percentage of patients will have symptoms that are refractory to such treatments.

9. Netherlands pubmed.ncbi.nlm.nih.gov

Two-Portal Endoscopic Plantar Fascia Release: Step-by-Step Surgical Technique. [2021] Plantar fasciitis is a common condition of heel pain with a lifetime incidence up to 10%. For this entity, conservative treatment is considered the gold standard, involving non-steroidal anti-inflammatory drugs, stretching exercises of the plantar fascia, activity modifications, ice, and insoles. When patients do not respond to these treatments, partial or total plantar fascia release has been the mainstay of treatment, with success rates of approximately 70% to 90%. For this purpose, several techniques have been described, including open, percutaneous, and endoscopic release. The objective of this Technical Note is to describe the nonassisted 2-portal endoscopic plantar fascia release in a patient with recalcitrant plantar fasciitis.