Therapeutic Shoes for Plantar Fasciitis

Overseen By Hafizur Rahman, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 18

Duration: 6 weeks

50 Participants Needed

Trial Summary

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. ^{1 2 3 4 5}

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. ^{1 3 5 6 7}

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. ^{1 5 7 8 9}

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.

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.

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

Treatment Details

Interventions

• OrthoFeet HandsFree Therapeutic Shoe

Trial Overview 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.

Participant Groups

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

Who Is Running the Clinical Trial?

University of Texas Rio Grande Valley

Lead Sponsor

Trials

8

Recruited

2,700+

Findings from Research

In a study comparing two types of ankle-foot orthoses (AFOs) for treating plantar fasciitis, two-thirds of participants reported reduced morning pain and stiffness after using either type of AFO.

The anterior AFO was found to be more effective and comfortable than the posterior AFO, which was associated with more discomfort and sleep disruption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison of two night ankle-foot orthoses used in the treatment of inferior heel pain: a preliminary investigation. Attard, J., Singh, D.[2012]

In a study involving 30 adults with plantar fasciitis, two types of prefabricated foot orthotics (soft supportive foam and foam covered rigid plastic) significantly reduced pain levels compared to a non-supportive orthotic, which showed no effect.

The foam covered rigid plastic orthotic was found to be the most effective, providing superior pain reduction and quicker onset of relief compared to the soft supportive foam orthotic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of different orthotic concepts as first line treatment of plantar fasciitis. Walther, M., Kratschmer, B., Verschl, J., et al.[2022]

In a study involving 142 adults with plantar fasciitis, both prefabricated and customized foot orthoses made from low-cost EVA foam showed significant improvement in pain after 8 weeks of use, indicating their effectiveness in treatment.

There was no significant difference in pain relief between the two types of orthoses, suggesting that low-cost prefabricated EVA inserts are a viable and effective option for treating uncomplicated plantar fasciitis.

NCBI (Pubmed)

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. Baldassin, V., Gomes, CR., Beraldo, PS.[2022]

In a study of 44 patients with plantar fasciitis, those who used a night splint showed significantly greater improvements in pain relief and function after two months compared to those who did not use the splint.

Despite the short-term benefits of using a night splint, the study found no significant effect on preventing recurrences of heel pain over a two-year follow-up period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The effectiveness of dorsiflexion night splint added to conservative treatment for plantar fasciitis]. Beyzadeoğlu, T., Gökçe, A., Bekler, H.[2019]

A study involving 15 patients with unilateral plantar fasciitis found that combining rocker shoes and custom-made foot orthoses significantly reduced heel pain more effectively than using either treatment alone, with a pain score of 9.7 mm compared to 30.9 mm for rocker shoes and 29.5 mm for foot orthoses.

The combination treatment also led to a greater reduction in peak pressure on the heel, decreasing it by 33.58%, which suggests that this approach not only alleviates pain but also redistributes pressure more effectively than the individual treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of combined prescription of rocker sole shoes and custom-made foot orthoses for the treatment of plantar fasciitis. Fong, DT., Pang, KY., Chung, MM., et al.[2019]

Customized 3D printed ankle-foot orthoses (AFOs) significantly improved comfort and reduced peak pressure in key areas of the foot for patients with plantar fasciitis compared to traditional prefabricated AFOs, as shown in a study of 60 patients over 8 weeks.

After 8 weeks, patients using the customized AFOs reported significantly greater comfort levels than those using prefabricated AFOs, indicating that customized solutions may be more effective in managing plantar fasciitis.

NCBI (Pubmed)

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. Xu, R., Wang, Z., Ma, T., et al.[2020]

A study involving 98 participants with plantar fasciitis showed that using both prefabricated orthotics and orthotic sandals significantly reduced foot pain and improved foot function compared to using orthotics alone.

While both treatment groups experienced pain relief and functional improvements, the combination of orthotics and sandals provided better outcomes, particularly in pain reduction as measured by the numerical rating scale.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of orthotics with orthotic sandals versus the sole use of orthotics for plantar fasciitis: Randomised controlled trial. Amoako-Tawiah, P., Love, H., Chacko Madathilethu, J., et al.[2023]

In a study of 22 patients with chronic plantar fasciitis, endoscopic plantar fascia release resulted in a high satisfaction rate of 97.7%, with all patients reporting at least a 50% improvement in pain after surgery.

The procedure was particularly effective for patients without prior foot trauma and those with unilateral symptoms, as 68% of patients achieved good or excellent results according to the modified Mayo Foot and Ankle Score.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endoscopic plantar fascia release. Hogan, KA., Webb, D., Shereff, M.[2017]

Plantar fasciitis affects up to 10% of people and is typically treated conservatively with methods like stretching, ice, and insoles, which are considered the gold standard.

For patients who do not improve with conservative treatments, endoscopic plantar fascia release shows a high success rate of 70% to 90%, making it an effective surgical option for chronic cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Two-Portal Endoscopic Plantar Fascia Release: Step-by-Step Surgical Technique. Campillo-Recio, D., Ibañez, M., Jimeno-Torres, E., et al.[2021]

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]

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

Effect of different orthotic concepts as first line treatment of plantar fasciitis. [2022]

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]

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

[The effectiveness of dorsiflexion night splint added to conservative treatment for plantar fasciitis]. [2019]

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]

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]

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]

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

Endoscopic plantar fascia release. [2017]

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

Two-Portal Endoscopic Plantar Fascia Release: Step-by-Step Surgical Technique. [2021]