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

Last updated: May 26, 2023
Sponsor: Maxima Medical Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Neuropathy

Peripheral Neuropathy

Chronic Pain

Treatment

Skin biopsy

Clinical Study ID

NCT05678127
NL81661.015.22
  • Ages 21-50
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  • Inability to understand Dutch language
  • Bilateral ACNES
  • Previously administered injections with corticosteroids at trigger point (injectionwith 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)

Study Design

Total Participants: 12
Treatment Group(s): 1
Primary Treatment: Skin biopsy
Phase:
Study Start date:
May 24, 2023
Estimated Completion Date:
December 31, 2023

Connect with a study center

  • Maxima Medical Center

    Veldhoven, 5504 DB
    Netherlands

    Active - Recruiting

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