A Novel Approach to Plantar Fasciitis in the Aging Population

NCT ID: NCT05834491

Last Updated: 2024-05-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 138 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-07
• Study Completion Date: 2025-05-31

Brief Summary

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.

Detailed Description

Twenty five percent of older adults experience foot pain. Plantar fasciitis, a repetitive strain injury, is one of the most common causes of foot pain in this population. Ten percent of aging adults experience plantar fasciitis with 50% of the cases being disabling. Foot pain can lead to other problems such as reduced mobility, depression and prescription medication use, leading to a reduced quality of life. Foot pain has been related to foot weakness, reduced static and dynamic balance, and reduced walking speed in aging adults.

The standard of care for plantar fasciitis is to brace the arch with foot orthoses and supportive shoes, thereby reducing the strain on the plantar fascia. However, arch support has been shown to be an ineffective long-term strategy for reducing foot pain, as well as leading to intrinsic foot muscle atrophy. As plantar fasciitis is associated with this atrophy, treating it with chronic arch support only increases the risk for recurrence. In fact, there is a 50% recurrence rate and a 45.6% risk of having plantar fasciitis 10 years after the onset of symptoms, and this risk increases with age.

Minimal shoes are designed to allow the foot to function naturally, as if barefoot, which have already been successfully implemented in older adults for the treatment of knee osteoarthritis. Minimal shoes are highly flexible and lack the support of conventional footwear. This places a greater demand on the foot muscles, which promotes strengthening. Indeed, studies of gradual transitioning to walking in minimal shoes have demonstrated significant increases in intrinsic foot muscle size and strength. Stronger foot intrinsic foot muscles have been shown to reduce the strain on the plantar fascia with each step, thereby reducing the risk of developing plantar fasciitis. This is especially important in the older population who develop muscle weakness as they age.

The overall objective of this study is to improve treatment interventions for plantar fasciitis in aging adults. The central hypothesis of this research is that strong intrinsic foot muscles will reduce the strain on the plantar fascia. This, in turn will result in resolution of pain, with less recurrence of plantar fasciitis than the standard of care. The investigators will test this hypothesis by comparing an intervention of stretching, foot orthoses and supportive shoes to one of foot stretching, strengthening and transition to minimal footwear. Training the foot of a patient with plantar fasciitis to function with less support is a significant paradigm shift from interventions aimed at passively supporting the foot. However, the investigators hypothesize that the dynamic stability of the foot muscles will be more effective than a static foot orthosis, that has been shown to promote foot weakening. The investigators will assess outcomes of foot pain, functional activities, and muscle strength, size and function at the 3- and 6-month follow-up, and the incidence of recurrence of plantar fasciitis at the 12 month time point.

Conditions

Plantar Fasciitis, Chronic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Minimal Footwear (Vivobarefoot)

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 Type: EXPERIMENTAL

minimal shoes and foot strengthening and flexibility exercises

Intervention Type: DEVICE

Flexible shoes that do not provide support and exercises aimed at increasing the strength of plantar intrinsic and extrinsic foot muscles along with foot flexibility exercises aimed at increasing the range of motion of the foot and ankle

Supportive Footwear

The control intervention is considered the standard of care and involves combination of foot stretching and the addition of supportive shoes and foot orthoses.

Group Type: ACTIVE_COMPARATOR

Supportive Footwear, foot orthotic device and foot flexibility exercises

Intervention Type: DEVICE

sturdy supportive shoes fitted with supportive foot orthotic devices and foot flexibility exercises aimed at increasing the range of motion of the foot and ankle

Interventions

minimal shoes and foot strengthening and flexibility exercises

Flexible shoes that do not provide support and exercises aimed at increasing the strength of plantar intrinsic and extrinsic foot muscles along with foot flexibility exercises aimed at increasing the range of motion of the foot and ankle

Intervention Type: DEVICE

Supportive Footwear, foot orthotic device and foot flexibility exercises

sturdy supportive shoes fitted with supportive foot orthotic devices and foot flexibility exercises aimed at increasing the range of motion of the foot and ankle

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1 Active plantar fasciitis for a minimum of 6 months. 2. Heel/arch pain on first step in the morning, 3. Heel/arch pain with prolonged standing (>15 min), 4. Heel/arch pain with prolonged walking (>15 min), 5. Be able to stand and walk for 10 minutes with little or no pain (<3/10 on a NRPS).

Exclusion Criteria

1. Having systemic disease such as diabetes, gout, arthritis, neuropathy, surgical reconstructions

2. Having a history of heel surgery or had a steroid injection for heel pain in the past 6 months.

3. Used foot orthoses less than 3 months before start date of study.

4. Having used minimal shoes at any time in the past.

5. No special or vulnerable populations will be recruited.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Hartford

OTHER

Sponsor Role: collaborator

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

University of South Florida

OTHER

Sponsor Role: lead

Responsible Party

Irene Davis

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of South Flroida

Tampa, Florida, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Irene Davis, PhD

Role: CONTACT

sdavis@usf.edu

3025596433

Facility Contacts

Irene Davis, Professor

Role: primary

Other Identifiers

1R01AG071646

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY004876

Identifier Type: -

Identifier Source: org_study_id