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

NCT ID: NCT05550831

Last Updated: 2023-05-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-15

Study Completion Date

2023-05-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Morton Neuroma Radriofrequency

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

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).
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Radiofrequency

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.

Group Type EXPERIMENTAL

Radiofrequency

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Radiofrequency

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

* Allergy to local anesthesia.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Universidad de Extremadura

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Alfonso Martínez Nova

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Alfonso Martínez Nova

Plasencia, Cáceres, Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Spain

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

REQUIEM

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.