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

Study Overview
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Brief Summary
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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.

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

Conditions
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Morton Neuroma, Radriofrequency

Intervention / Treatment
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* Procedure: Radiofrequency


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Radiofrequency<br>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<br>* Peripheral ablation of affected Morton´s Neuroma nerve endings by thermal dissipation by an electrode.<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Foot, Morton Neuroma, Radiofrequency