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

Primary Purpose

Morton Neuroma, Radriofrequency

Status

Active

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

Radiofrequency

About this trial

This is an interventional treatment trial for Morton Neuroma focused on measuring Foot, Morton Neuroma, Radiofrequency

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Alfonso Martínez Nova

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Radiofrequency

Arm Description

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.

Outcomes

Primary Outcome Measures

Nerve Damage

Anatomopathology of the nerve

Quality of Life, FFI

FFI Questionnaire

Secondary Outcome Measures

Full Information

NCT ID

NCT05550831

First Posted

September 19, 2022

Last Updated

May 9, 2023

Sponsor

Universidad de Extremadura

1. Study Identification

Unique Protocol Identification Number

NCT05550831

Brief Title

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

Acronym

REQUIEM

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

October 15, 2022 (Actual)

Primary Completion Date

November 15, 2022 (Actual)

Study Completion Date

May 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Universidad de Extremadura

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Morton Neuroma, Radriofrequency

Keywords

Foot, Morton Neuroma, Radiofrequency

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

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).

Masking

None (Open Label)

Allocation

N/A

Enrollment

34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Radiofrequency

Arm Type

Experimental

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Radiofrequency

Intervention Description

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

Primary Outcome Measure Information:

Title

Nerve Damage

Description

Anatomopathology of the nerve

Time Frame

1 week

Title

Quality of Life, FFI

Description

FFI Questionnaire

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

Alfonso Martínez Nova

City

Plasencia

State/Province

Cáceres

ZIP/Postal Code

10600

Country

Spain

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

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