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Trial Title:
Radiofrequency Before to Surgical Removal of a Recalcitrant Morton´s Neuroma
NCT ID:
NCT05550831
Condition:
Morton Neuroma
Radriofrequency
Conditions: Official terms:
Neuroma
Morton Neuroma
Conditions: Keywords:
Foot
Morton Neuroma
Radiofrequency
Study type:
Interventional
Study phase:
N/A
Overall status:
Active, not recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention 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).
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Radiofrequency
Description:
Peripheral ablation of affected Morton´s Neuroma nerve endings by thermal dissipation by
an electrode.
Arm group label:
Radiofrequency
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Alfonso Martínez Nova
Address:
City:
Plasencia
Zip:
10600
Country:
Spain
Start date:
October 15, 2022
Completion date:
May 15, 2023
Lead sponsor:
Agency:
Universidad de Extremadura
Agency class:
Other
Source:
Universidad de Extremadura
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05550831
