Radiofrequency Before to Surgical Removal of a Recalcitra... | NCT05550831

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

NCT05550831

Sponsor

Universidad de Extremadura

Status

Unknown status

Last Update Posted

May 10, 2023Actual

Enrollment

34Estimated

Phase

Not Applicable

Conditions

Morton Neuroma
Radriofrequency

Interventions

Radiofrequency

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 15, 2022Actual

Primary Completion Date

Nov 15, 2022Actual

Completion Date

May 15, 2023Estimated

First Submitted Date

Sep 19, 2022

First Submission Date that Met QC Criteria

Sep 19, 2022

First Posted Date

Sep 22, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 9, 2023

Last Update Posted Date

May 10, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

34Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Radiofrequency	Experimental	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Radiofrequency	Procedure	Peripheral ablation of affected Morton´s Neuroma nerve endings by thermal dissipation by an electrode.	Radiofrequency

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Alfonso Martínez Nova		Plasencia	Cáceres	10600	Spain

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000070607	Morton Neuroma

Ancestor Terms

ID	Term
D037061	Metatarsalgia
D005534	Foot Diseases
D009140	Musculoskeletal Diseases
D007592	Joint Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

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).