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

May 9, 2023 updated by: Alfonso Martínez Nova, Universidad de Extremadura
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Cáceres
      • Plasencia, Cáceres, Spain, 10600
        • Alfonso Martínez Nova

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Procedure: Radiofrequency
Peripheral ablation of affected Morton´s Neuroma nerve endings by thermal dissipation by an electrode.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nerve Damage
Time Frame: 1 week
Anatomopathology of the nerve
1 week
Quality of Life, FFI
Time Frame: 6 months
FFI Questionnaire
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de Extremadura

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2022

Primary Completion (Actual)

November 15, 2022

Study Completion (Anticipated)

May 15, 2023

Study Registration Dates

First Submitted

September 19, 2022

First Submitted That Met QC Criteria

September 19, 2022

First Posted (Actual)

September 22, 2022

Study Record Updates

Last Update Posted (Actual)

May 10, 2023

Last Update Submitted That Met QC Criteria

May 9, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REQUIEM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe