Clinical trial NCT05834491: A Novel Approach to Plantar Fasciitis in the Aging Population
Official title: A Novel Approach to Plantar Fasciitis in the Aging Population
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Plantar Fasciitis, Chronic
Keywords: minimal footwear, pain, function, strengthening
Lead sponsor: University of South Florida
Sponsor class: OTHER
Collaborators: name: University of Hartford
name: National Institute on Aging (NIA)
First posted: 2023-04-28
Enrollment: 138
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Foot Health Status Questionnaire (FHSQ)
timeFrame: Baseline
measure: Foot Health Status Questionnaire (FHSQ)
timeFrame: 3 months
measure: Foot Health Status Questionnaire (FHSQ)
timeFrame: 6 months
measure: Foot pain
timeFrame: Baseline
measure: Foot pain
timeFrame: 1 month
measure: Foot pain
timeFrame: 2 months
measure: Foot pain
timeFrame: 3 months
measure: Foot pain
timeFrame: 4 months
measure: Foot pain
timeFrame: 5 months
measure: Foot pain
timeFrame: 6 months
measure: Foot pain
timeFrame: 7 months
measure: Foot pain
timeFrame: 8 months
measure: Foot pain
timeFrame: 9 months
measure: Foot pain
timeFrame: 10 months
measure: Foot pain
timeFrame: 11 months
measure: Foot pain
timeFrame: 12 months
measure: Step counts
timeFrame: Baseline
measure: Step counts
timeFrame: 1 month
measure: Step counts
timeFrame: 2 months
measure: Step counts
timeFrame: 3 months
measure: Step counts
timeFrame: 4 months
measure: Step counts
timeFrame: 5 months
measure: Step counts
timeFrame: 6 months
measure: Step counts
timeFrame: 7 months
measure: Step counts
timeFrame: 8 months
measure: Step counts
timeFrame: 9 months
measure: Step counts
timeFrame: 10 months
measure: Step counts
timeFrame: 11 months
measure: Step counts
timeFrame: 12 months
measure: Global Rating Outcome Change (GROC)
timeFrame: 3 months
measure: Global Rating Outcome Change (GROC)
timeFrame: 6 months
measure: Patient Acceptable Symptom State (PASS)
timeFrame: 3 months
measure: Patient Acceptable Symptom State (PASS)
timeFrame: 6 months
Secondary outcomes:
measure: International Physical Activity Questionnaire (IPAQ)
timeFrame: Baseline
measure: International Physical Activity Questionnaire (IPAQ)
timeFrame: 3 months
measure: International Physical Activity Questionnaire (IPAQ)
timeFrame: 6 months
measure: Static and dynamic balance
timeFrame: Baseline
measure: Static and dynamic balance
timeFrame: 3 months
measure: Static and dynamic balance
timeFrame: 6 months
measure: Muscles size of cross sectional area
timeFrame: Baseline
measure: Muscles size of cross sectional area
timeFrame: 3 months
measure: Muscles size of cross sectional area
timeFrame: 6 months
measure: Muscle Strength
timeFrame: Baseline
measure: Muscle Strength
timeFrame: 3 months
measure: Muscle Strength
timeFrame: 6 months
Other outcomes:
Locations:
city: Tampa
country: United States
facility: University of South Flroida
state: Florida
Study officials:
References: