Radiofrequency Before to Surgical Removal of a Recalcitrant Morton´s Neuroma

NCT05550831 | Unknown DMC

• 1 other identifier: REQUIEM
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to perform a radiofrequency procedure prior to the removal of morton's neuroma. This procedure would be performed to check in which percentage of the nerve ablation has been performed, and whether the current protocol is performed correctly or parts of the nerve remain intact.

Conditions

Morton Neuroma; Radriofrequency

Keywords

Foot; Morton Neuroma; Radiofrequency

Outcome Measures

Primary Outcomes (2)

• Nerve Damage

  Anatomopathology of the nerve

  1 week

• Quality of Life, FFI

  FFI Questionnaire

  6 months

Study Arms (1)

Radiofrequency

EXPERIMENTAL

Radiofrequency procedure prior to the removal of morton's neuroma. * Radiofrequency Machine: Multilesion Generator 3 Channels TLG-10 STP. * Temperature: 80-85ºC * Time: 90 seconds * Active needle size: 1 cm * Number of Applications: 3 * Impedance: less than 550 * Ultrasound. General Electric Logic R7 with 12 Mgh probe.

Procedure: Radiofrequency

Interventions

Radiofrequency PROCEDURE

Peripheral ablation of affected Morton´s Neuroma nerve endings by thermal dissipation by an electrode.

Radiofrequency

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient aged between 18 and 70 years
• Patient with neuroma of morton of more than 1 year of evolution
• Patient treated by conservative treatments, stencils, various infiltrations, stretching and with symptomatology that limits his daily activities.
• Healthy patients without previous systemic pathologies (diabetes, coagulation or immunological disorders), ASA I or II that require and demand surgical treatment of their pathology in the participating centers and willing to participate in the study.
• freely accept and sign the informed consent for participation in the study.

You may not qualify if:

• Allergy to local anesthesia.

Sponsors & Collaborators

• Universidad de Extremadura: lead

Study Sites (1)

Alfonso Martínez Nova

Plasencia, Cáceres, 10600, Spain

Location

MeSH Terms

Conditions

Morton Neuroma

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Model Details: Performing a radiofrequency procedure prior to the removal of morton's neuroma. This procedure would be performed to check in which percentage of the nerve ablation has been performed, and whether the current protocol is performed correctly or parts of the nerve remain intact. * Step 1: Visualize the needle on the long axis of the probe. * Step 2: Neurostimulate * Step 3: Deposit of 1-2cc of anesthetic and wait about 2 minutes. * Step 4: we apply the continuous radiofrequency at that point and once done we change the position of the needle to more dorsal planes anatomically and we made 2 more applications (in this case we will no longer have neurostimulation because the patient will be anesthetized).

Study Record Dates

• First Submitted: September 19, 2022
• First Posted: September 22, 2022
• Study Start: October 15, 2022
• Primary Completion: November 15, 2022
• Study Completion: May 15, 2023
• Last Updated: May 10, 2023

Record last verified: 2023-05

Locations

ES (1)