NCT05713175

Orthopaedic Treatment in Propulsive Metatarsalgia

Effectiveness of Orthopaedic Treatment in Propulsive Metatarsalgia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Universidad Complutense de Madrid · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Type of Study: Randomised Clinical Trial. Aim: To compare the effect of orthopedic treatment on foot pain and functionality in subjects diagnosed with propulsive metatarsalgia. Study Protocol Description: Prior to the start of the study, a calculation of the sample size will be made using the GRANMO Sample Size Calculator, version .12 April 2012, with an error of 5%, assuming a confidence level of 95% and values of ß that establish an analysis power of 80%. The study population will be randomly divided into two treatment groups, which, in turn, will be subdivided into two groups. Said randomization will be carried out using an online tool (www.randomization.com). Treatment groups are: * Group A: Treatment by custom insoles made of 4.5mm polypropylene, balanced in inversion 0-4º, MLA of the patient, 4mm-heel rise and metatarsal dome. * Group A1: Treatment from the date of diagnosis until the start of insoles use (3 weeks) using the Fix-Toe® device. * Group A2: Without orthopedic treatment from the date of diagnosis until the start of insoles use (3 weeks). * Group B: Treatment by custom insoles made of 45º shore A E.V.A with the patient's MLA, 4mm- heel rise and metatarsal dome. * Group B1: Treatment from the date of diagnosis until the start of insoles use (3 weeks) using the Fix-Toe® device. * Group B2: Without orthopedic treatment from the date of diagnosis until the start of insoles use (3 weeks). Visits protocol is as follows: * Day 1: inclusion, clinical and radiographical evaluation. Pain questionnaires fulfillment.Treatment group allocation. * Day 2 (3 weeks after Day 1): Pain questionnaires fulfillment. Starts insoles treatment. * Day 3 (6 weeks after Day 2): Pain questionnaires fulfillment (telephone). * Day 4 (6 weeks after Day 3): Pain questionnaires fulfillment. Clinical evaluation. End of study.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-01-01
• Primary completion: 2023-01-01
• Completion: 2023-01-01
• First posted: 2023-02-06
• Last updated: 2023-02-06

Locations

1 site across 1 country: Spain