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

NCT05678127 | Unknown DMC

• 1 other identifier: NL81661.015.22
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Diagnostic test for ACNES; Intraepidermal nerve fibre density (IENFD)

Outcome Measures

Primary Outcomes (1)

• Intraepidermal Nerve Fibre density (IENFD)

  Difference in IENFD (measured in IENF/mm) from both affected and non-affected side of the abdominal wall.

  Both biopsies will be taken at the same time, as their difference will be studied. The biopsies will be taken at the second outpatient visit, 2 or 3 weeks after the first visit, just after the second triggger point injection (standard of care).

Secondary Outcomes (3)

• Pain score

  Assessed at first outpatient visit, used as baseline data.

• Duration of pain

  Assessed at first outpatient visit, used as baseline data.

• Treatment response

  Treatment response will be assessed 2 to 6 weeks after each treatment (trigger point injections, PRF and neurectomy), as standard of care.

Study Arms (1)

Patients with unilateral ACNES

EXPERIMENTAL

Procedure: Skin biopsy

Interventions

Skin biopsy 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.

Patients with unilateral ACNES

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Maxima Medical Center: lead

Study Sites (1)

Maxima Medical Center

Veldhoven, 5504 DB, Netherlands

RECRUITING

MeSH Terms

Conditions

Charcot-Marie-Tooth Disease; Disease

Condition Hierarchy (Ancestors)

Hereditary Sensory and Motor Neuropathy; Nervous System Malformations; Nervous System Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Rudi Roumen, MD, PhD

  Maxima Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tom ten Have, MD

CONTACT

+31408887461; Tom.ten.Have@mmc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: 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.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of surgery, Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: December 29, 2022
• First Posted: January 10, 2023
• Study Start: May 24, 2023
• Primary Completion: November 1, 2023
• Study Completion: December 1, 2023
• Last Updated: May 31, 2023

Record last verified: 2023-05

Locations

NL (1)