A Test of Efficacy and Foot Position Alteration in Patients Wearing Good Feet Arch Supports for the Treatment of Pain

NCT07103070 | Completed DMC

• 1 other identifier: 2022P000291
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Plantar Fasciitis of Both Feet; Metatarsalgia; Morton Neuroma; Hallux Valgus Deformity; Low Back Pain; Knee Pain; Ankle Pain

Keywords

arch supports; heel pain; metatarsalgia; plantar fasciitis

Outcome Measures

Primary Outcomes (2)

• Patient Reported Outcome Measurement Information System (PROMIS)-Pain Intensity Score

  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.

  12 weeks

• Patient Reported Outcome Measurement Information System (PROMIS)-Pain Interference Score

  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.

  12 weeks

Secondary Outcomes (3)

• 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

Study Arms (1)

Inclusion 1. Men or women ≥ 18 and ≤ 65 years of age 2. The subject is able and willing to comply w

Subjects with foot pain who are able to wear arch supports.

Device: Arch supports

Interventions

Arch supports DEVICE

Set of 3 arch supports supplied by Good Feet

Inclusion 1. Men or women ≥ 18 and ≤ 65 years of age 2. The subject is able and willing to comply w

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects will be recruited from the clinicians in the Division of Podiatry under the Department of Orthopaedics. Additionally, the sponsor, Good Feet Worldwide has a trade store the MGH service area, and will allow us to promote the study at their location with an advertisement poster. Potential subjects from the trade store will be referred to our clinics for screening and, when appropriate, recruited for the study.

You may qualify if:

• 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
• BMI ≤ 35
• Able to walk up to 0.5 miles without difficulty in a 24-hour period

You may not qualify if:

• 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
• BMI \> 35.
• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Metatarsalgia; Morton Neuroma; Low Back Pain; Fasciitis, Plantar

Interventions

Foot Orthoses

Condition Hierarchy (Ancestors)

Foot Diseases; Musculoskeletal Diseases; Joint Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neuralgia; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Back Pain; Fasciitis

Intervention Hierarchy (Ancestors)

Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies

Study Officials

• Adam S Landsman, DPM, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 14, 2025
• First Posted: August 5, 2025
• Study Start: June 13, 2022
• Primary Completion: December 31, 2023
• Study Completion: March 31, 2024
• Last Updated: August 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)