NCT05678127

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

Skin Biopsy as Diagnostic Tool in Anterior Cutaneous Nerve Entrapment Syndrome (ACNES): A Pilot Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Maxima Medical Center · Academic / Other
• Sex: All
• Age: 21 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

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

Interventions

Type	Name	Description
PROCEDURE	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.

Timeline

• Start date: 2023-05-24
• Primary completion: 2023-11-01
• Completion: 2023-12-01
• First posted: 2023-01-10
• Last updated: 2023-05-31

Locations

1 site across 1 country: Netherlands