Baropodometric Patterns Associated With Metatarsalgia

NCT06534073 | Active Not Recruiting

• 1 other identifier: N2009020
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

The therapeutic plan for certain pathologies in the adult population typically includes the performance of moderate physical activity aimed at preventing cardiovascular risk due to sedentary lifestyle, improving muscle tone and balance to prevent falls, enhancing bone health, and maintaining proper functional and mental health state. However, this activity can be hindered by pain arising from musculoskeletal injuries of low or moderate significance. One such injury is metatarsalgia, characterized by acute or chronic pain in the plantar area of the forefoot due to an overload of plantar pressure. It affects one or several central metatarsals and their respective metatarsophalangeal joints. Metatarsalgia is a highly prevalent pathology (up to 83%) in patients aged 60 or older and negatively impacts their quality of life. To alleviate plantar pressure in the affected area, metatarsal offloading devices are commonly used, which can now be integrated into socks or stockings. This integration aids in pain reduction through an everyday, easy-to-use item. However, only preliminary results of their effectiveness exist, and are in a standard model without customization for the patient's foot. Therefore, the goal is to identify different plantar pressure patterns in a sample of female patients over 55 years with metatarsalgia and design personalized three-dimensional plantar elements that can be integrated into the sock's structure to reduce over pressure and improve the clinical picture. A prior evaluation of pain (Foot Pain and Disability Index), impact on quality of life (SF-12 questionnaire), assessment of physical activity (IPAQ), and baropodometric evaluation with instrumented Pedar® insoles (Novel, Germany) will be conducted. This will characterize the patterns of plantar pain. Using 3D scanning of the foot, a personalized three-dimensional element for each plantar pain pattern will be designed to relieve this excess load, and will be integrated into the body of the sock through weaving, thermofusion, or thermosealing. This sample of patients with metatarsalgia will be randomly divided into three groups, who for a period of six months will wear the offloading sock model, personalized plantar supports with selective offloading, or a stabilizing element for the affected metatarsal head that the patient can apply and remove themselves. After these six months, plantar pain, quality of life, and physical activity levels will be re-evaluated in the three groups to determine the potential efficacy of the experimental sock compared to the best possible treatment, insoles, and another common element such as alignment devices. The offloading sock would provide a personalized solution for each patient, requiring no adaptation or frequent replacement, thus creating better adherence to treatment. The number of effective treatment usage hours would increase since socks are part of the patients' regular attire. Additionally, associated costs would be reduced, as there would be no need for frequent replacement of removable pads, stabilizing devices, or regular revisions to adjust orthopedic insoles.

Conditions

Metatarsalgia

Outcome Measures

Primary Outcomes (1)

• Numeric Pain Rating Score 11

  Pain under the metatarsal heads of the feet, using the Numeric Pain Rating Score 11 (NPRS-11), in which the minimum value is 0 (no pain) and the maximum value is 10 (the worst imaginable pain).

  4 weeks

Study Arms (3)

Socks

EXPERIMENTAL

The intervention will be the daily use of socks with the integration of the customized orthotic element.

Device: Socks

Standard device

OTHER

The intervention will be the daily use of external orthotic elements (to be put on and taken off daily) and of standard manufacture.

Device: Standard device

Foot orthoses

OTHER

The participants will receive completely personalized plantar supports integrating the relief element.

Device: Foot orthoses

Interventions

Socks DEVICE

Plantar orthotic elements will be designed, according to the participants' previous baropodometric pattern, to alleviate pathological plantar pressure. These elements will be integrated into commonly worn items by patients, such as stockings or socks.

Socks

Standard device DEVICE

Removable device of digital alignment to stabilize and unload the affected metatarsophalangeal joint. They do not require frequent replacement as they are washable and reusable elements.

Standard device

Foot orthoses DEVICE

Custom-made foot orthoses.

Foot orthoses

Eligibility Criteria

• Age: 55 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female sex;
• Age ≥ 55 years;
• Experiencing moderate to severe pain in the plantar area of the forefoot;
• Presenting hyperkeratosis under the central metatarsal heads;
• Presenting pre-dislocation syndrome of the second or third metatarsophalangeal joint.

You may not qualify if:

• Present cognitive deterioration that impedes the proper development of the study;
• Have undergone previous osteoarticular surgeries on the feet;
• Diagnosis of rheumatoid arthritis with involvement in the metatarsophalangeal joints of the foot;
• Present symptoms compatible with Morton's neuritis;
• Use of walking aids;
• Are under treatment with insoles;
• Refuse the use of designated socks or plantar supports during the follow-up period.

Sponsors & Collaborators

• University of Seville: lead

Study Sites (1)

Facultad de Enfermería, Fisioterapia y Podología

Seville, Seville, 41008, Spain

Location

MeSH Terms

Conditions

Metatarsalgia

Interventions

Foot Orthoses

Condition Hierarchy (Ancestors)

Foot Diseases; Musculoskeletal Diseases; Joint Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 25, 2024
• First Posted: August 2, 2024
• Study Start: October 1, 2025
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, CSR

Locations

ES (1)