A Test of Efficacy and Foot Position Alteration in Patients Wearing Good Feet Arch Supports for the Treatment of Pain
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 43
- Locations
- 1
- Primary Endpoint
- Patient Reported Outcome Measurement Information System (PROMIS)-Pain Intensity Score
Study Overview
Brief Summary
This study is a single armed prospective case series designed to evaluate the efficacy of treating common structural-related foot ailments (i.e. plantar fasciitis, metatarsalgia, and/or hallux valgus) with a high quality non-custom made arch support. It is believed that these conditions are the result of inadequate or poorly fitted arch supports resulting in a lack of structural correction in the foot while weight bearing. Over-the-counter insoles are believed to counteract the shortcomings in foot structure that result in these painful conditions. In this study, it is proposed that changes in foot morphology can be measured quantitatively using weight bearing CT Scan (Computerized Tomography) and X-rays of the subject with and without the arch supports. Subjects will also answer questions from a validated series of questionnaires pertaining to their foot condition and generalized health and activity level.
The study is a minimal risk study, with all subjects receiving the arch supports being investigated. There is no placebo offered. Initial evaluation of all subjects will include all imaging and measurements. Collection of subjective responses will occur after 4 weeks, 8 weeks, and 12 weeks of treatment.
Detailed Description
- Background and Significance
Foot orthoses are arch supports that can be worn in the shoes, and are designed to relieve pain by providing support to various areas of the foot to eliminate or reduce excessive mechanical forces. Most commonly, these devices are used as part of the treatment protocol for a variety of common foot ailments including painful plantar fasciitis and pronation. A variety of musculoskeletal pains have been shown to be reduced, and stability in ambulation can be improved by adding arch support to the shoes. Most importantly, previous studies have demonstrated that the structure of the foot can be altered, and with that the function of the foot, when orthoses are used.
Previous studies have demonstrated multiple biomechanical and clinical benefits of using foot orthoses and arch supports. These devices have been shown to alter foot positioning and forefoot pressure during walking, reducing heel and forefoot pressures, decreasing impact forces, and improving comfort. Cadaveric studies confirm that orthoses enhance ankle and subtalar joint stability, correct abnormal rotations, improve arch alignment, and increase arch height under simulated load. Clinical studies involving military personnel found that wearing arch supports significantly reduced stress fracture incidence and improved comfort. Additionally, arch supports were associated with decreased lower back pain after prolonged use. Research also indicated that orthotic devices reduce tibial internal rotation, influencing the mechanical function of proximal structures like the ankle and leg. Furthermore, orthoses positively impacted foot deformities, pain (foot, knee, hip, and back), and balance, as demonstrated by radiographic and center-of-pressure analyses, indicating overall improvements in stability and symptomatic relief.
The goal of the current study is to investigate the clinical and biomechanical effects of arch-support insoles in common foot pathologies including plantar fasciitis, and metatarsalgia. 2. Specific Aims and Objectives
The objective of this study is to measure the structural changes that occur in the foot when wearing arch supports, and how these changes correlate with overall relief of common structural-related foot ailments; plantar fasciitis, metatarsalgia, and/or hallux valgus
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Men or women ≥ 18 and ≤ 65 years of age
- •Able and willing to comply with study procedures, and a signed and dated
- •Diagnosed with symptomatic hallux valgus and/or plantar fasciitis and/or metatarsalgia
- •Has had foot pain for at least 30 days
- •Willing and able to utilize insole when walking for 90 days
- •Able to walk up to 0.5 miles without difficulty in a 24-hour period
Exclusion Criteria
- •Inability or unwillingness to comply with study procedures
- •Gross asymmetry in feet, where shoe size differs by 2 or more full sizes between right and left foot
- •Subject has had a CT performed within the last 30 days, for any body part.
- •Prior partial or total amputation of a foot
- •Unilateral or bilateral foot deformity that would hinder the fitting of an over-the-counter arch support, such as active Charcot foot or Charcot with boney prominence
- •Ulcers or open sores on either foot
- •Currently wearing custom shoes or insoles.
- •Currently ambulating with a cane, crutches, walker.
- •Currently using any type of foot or ankle brace, and/or having used a brace in the last 30 days.
- •Pregnancy
Outcomes
Primary Outcomes
Patient Reported Outcome Measurement Information System (PROMIS)-Pain Intensity Score
Time Frame: 12 weeks
Change in symptoms and relief of pain will be quantified based on subjective completion of validated questionnaires. Scoring is based on a 5-point scale, with higher scores indicating greater pain intensity. Raw scores are converted to T-scores, standardized to a mean of 50 (average for the general population) and a standard deviation of 10. Higher T-scores reflect more severe pain intensity.
Patient Reported Outcome Measurement Information System (PROMIS)-Pain Interference Score
Time Frame: 12 weeks
PROMIS Pain Interference measures the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities. Respondents rate how much pain has interfered with their daily life over the past 7 days. Scoring uses a 5-point scale, with higher scores indicating greater interference. Raw scores are converted to T-scores (mean = 50, SD = 10); higher T-scores represent more significant pain interference.
Secondary Outcomes
- Change in foot morphology- Weightbearing X-ray(Baseline)
- Change in foot morphology- Weightbearing CT scans(Baseline)
- Patient Reported Outcome Measurement Information System (PROMIS)-Global Health(12 weeks)
Investigators
Adam S. Landsman, DPM, PhD
Assistant Professor
Massachusetts General Hospital