Orthopaedic Treatment in Propulsive Metatarsalgia

Summary

The goal of this clinical trial is to compare the effectiveness of two conservative orthopedic treatments in propulsive metatarsalgia.

The main question it aims to answer are:

* To compare the effectiveness of treatments on foot pain and functionality in subjects diagnosed with propulsive metatarsalgia.
* To determinate the influence of clinical and radiographical characteristics in pain improvement.

Participants will wear the treatment for 3 months . Researchers will compare polypropylene and EVA insoles and Fixtoe Device® to see if a foot pain improvement is achieved.

Conditions

• Metatarsalgia
• Treatment
• Foot
• Foot Diseases
• Orthopedic Disorder
• Subluxation of Toe Joint
• Toe Joint Deformity

Interventions

DEVICE

EVA plantar orthosis

Treatment consisting of a personalized plantar orthosis fabricated in 45º shore A hardness Ethyl Vinyl Acetate (EVA), which incorporates a 4mm heel rise and metatarsal dome placed proximal to the 2nd-3rd-4th metatarsal heads. No modifications applied to the patients' medial longitudinal arch.

DEVICE

Polypropylene plantar orthosis

Treatment consisting of a personalized plantar orthosis fabricated in 4mm polypropylene, which incorporates a 4mm heel rise and metatarsal dome placed proximal to the 2nd-3rd-4th metatarsal heads. No modifications applied to the patients' medial longitudinal arch.Orthosis fabricated following the inverted orthotic technique.

DEVICE

Fixtoe device

Fixtoe Device, simulating the metatarsophalangeal stabilization tape technique is worn for one month, prior to definitive treatment consisting of a personalized plantar orthosis.

Sponsors & Collaborators

• Universidad Complutense de Madrid

  lead OTHER

Principal Investigators

• Ángel M Orejana-García, PhD · Complutense University Madrid

• Raúl J Molines-Barroso, PhD · Complutense University Madrid

• José Luis Lázaro-Martínez, PhD · Complutense University Madrid

• Maria Ruiz-Ramos, MSc · Complutense University Madrid

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-01-01

Primary Completion

2023-01-01

Completion

2023-01-01

Countries

• Spain

Study Locations