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

Not Applicable

Active, not recruiting

• Conditions: Morton Neuroma; Radriofrequency
• Interventions: Procedure: Radiofrequency

• Registration Number: NCT05550831
• Lead Sponsor: Universidad de Extremadura

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-19
• Study First Submitted QC: 2022-09-19
• Study First Posted: 2022-09-22
• Study Start: 2022-10-15
• Primary Completion: 2022-11-15
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-09
• Last Update Posted: 2023-05-10
• Study Completion: 2023-05-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 34

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Radiofrequency	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.

Primary Outcome Measures

Name	Time	Method
Quality of Life, FFI	6 months	FFI Questionnaire
Nerve Damage	1 week	Anatomopathology of the nerve

Trial Locations

Locations (1)

Alfonso Martínez Nova; 🇪🇸 Plasencia, Cáceres, Spain