A Pilot Study to Explore the Use of Skin Biopsy as Diagnostic Tool in Anterior Cutaneous Nerve Entrapment Syndrome (ACNES)

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

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-24

Study Completion Date

2023-12-31

Brief Summary

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ACNES is a neuropathic pain condition of the abdominal wall. It is a clinical diagnosis based on patient's history and physical examination. No diagnostic test is available to confirm the diagnosis.

This pilot study will determine if skin biopsies can be used as diagnostic test. Two 3mm biopsies will be taken and used to count the small nerve fibres in the skin. The number of small nerve fibres of the painful skin will be compared to non-painful skin. Skin biopsy and small fibre nerve count is already used as diagnostic test in patients with small-fibre neuropathy.

The investigators hypothesize that patients with ACNES will have a reduced number of small nerve fibres in the affected skin, compared to the non-affected skin.

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Detailed Description

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Conditions

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Anterior Cutaneous Nerve Entrapment Syndrome Nerve Entrapment Syndrome Chronic Pain Syndrome Diagnosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Skin biopsies will be performed on patients with an unilateral ACNES. Biopsies will be taken at the triggerpoint (affected side) and contralateral, non-affected side of the abdominal wall.

Affected vs non-affected will be compared. The non-affected side serves as control.

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

The pathologists who will measure the nerve fibre density are blinded; they will not know if the biopsy is from the affected or non-affected side.

Study Groups

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Patients with unilateral ACNES

Group Type EXPERIMENTAL

Skin biopsy

Intervention Type PROCEDURE

Two 3mm skin biopsies from the abdominal wall will be taken. One at the triggerpoint of the pain, the second one at the contralateral, non-affected side of the abdominal wall.

Lidocaine will be used for local anaesthesia of the skin, before the biopsies will be taken.

Interventions

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Skin biopsy

Two 3mm skin biopsies from the abdominal wall will be taken. One at the triggerpoint of the pain, the second one at the contralateral, non-affected side of the abdominal wall.

Lidocaine will be used for local anaesthesia of the skin, before the biopsies will be taken.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Duration of pain \>3 months
* Newly diagnosed unilateral ACNES
* Fully completed intake questionnaire
* Obtained written informed consent

Exclusion Criteria

* Inability to understand Dutch language
* Bilateral ACNES
* Previously administered injections with corticosteroids at trigger point (injection with a local anaesthetic is allowed)
* Previous Pulsed Radiofrequency (PRF)-treatment at trigger point
* History of open abdominal surgery
* History of neurectomy
* Known neuromuscular or neurodegenerative disease
* Antiplatelet or anticoagulants use or known coagulation disorders
* Disorder known to cause a reduced IENFD;

* Diabetes
* Hypothyroidism
* Renal failure
* Vitamin B12 deficiency
* Monoclonal gammopathy
* Alcohol abuse (\>5 IU a day)
* Malignancies
* Medication that cause neuropathy (for example chemotherapy)

Minimum Eligible Age

21 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No