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

Morton Neuroma Clinical Trial

— REQUIEM  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05550831
• Other study ID #: REQUIEM
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 15, 2022
• Est. completion date: May 15, 2023

Study information

• Verified date: May 2023
• Source: Universidad de Extremadura
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 34
• Est. completion date: May 15, 2023
• Est. primary completion date: November 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Morton Neuroma
• Neuroma

Intervention

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

Locations

Country	Name	City	State
Spain	Alfonso Martínez Nova	Plasencia	Cáceres

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Extremadura

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nerve Damage	Anatomopathology of the nerve	1 week
Primary	Quality of Life, FFI	FFI Questionnaire	6 months