Sodium Channel Mutations in Patient With the Anterior Cutaneous Nerve Entrapment Syndrome (ACNES)

NCT ID: NCT05877274

Last Updated: 2023-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-03

Study Completion Date

2024-12-31

Brief Summary

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The goal of this observational study is to learn about sodium channel (Nav) mutations in patients with the Anterior Cutaneous Nerve Entrapment Syndrome (ACNES). This study will give more insight into the pathophysiology of ACNES, which is still largely unknown.

The primary objective is to determine if there are mutations of Nav1.7 and Nav1.8 in patients with ACNES. Therefore, one blood sample will be drawn, in which the mutations will be analyzed.

Detailed Description

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Conditions

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Anterior Cutaneous Nerve Entrapment Syndrome Nerve Entrapment Syndrome Chronic Pain Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Patients with ACNES

Patients with ACNES who fulfill the inclusion criteria.

Sodium channel mutation

Intervention Type OTHER

Mutation of the genes SCN9A and SCN10A, which encode for Sodium channel 1.7 and 1.8.

Interventions

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Sodium channel mutation

Mutation of the genes SCN9A and SCN10A, which encode for Sodium channel 1.7 and 1.8.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

In order to be eligible to participate in this study, a subject must be diagnosed with ACNES and receive treatment at our outpatient clinic. Additionally, subject has to meet one of the following criteria:

* Known to have a first- or second-degree relative with ACNES;
* Have more than one recurrence of ACNES after a pain free period or ACNES at multiple locations in the abdominal wall;
* Persistent pain after posterior neurectomy.

Exclusion Criteria

* Inability to understand Dutch language.
* Known neuromuscular or neurodegenerative disease.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Maxima Medical Center

OTHER

Sponsor Role lead

Responsible Party

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dr. RMH Roumen, surgeon

Head of surgery, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rudi Roumen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Maxima Medical Center

Locations

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Maxima Medical Center

Veldhoven, , Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Tom ten Have, MD

Role: CONTACT

0408887461

Facility Contacts

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Tom ten Have, MD

Role: primary

+31408887461

Other Identifiers

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NL84021.015.23

Identifier Type: -

Identifier Source: org_study_id

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