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

NCT05678127 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2023-05-31

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Maxima Medical Center

    lead OTHER

Principal Investigators

  • Rudi Roumen, MD, PhD · Maxima Medical Center

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-24
Primary Completion
2023-11-30
Completion
2023-12-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05678127 on ClinicalTrials.gov