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

Maxima Medical Center

Status: Enrolling

Conditions: Chronic Pain Syndrome; Anterior Cutaneous Nerve Entrapment Syndrome; Diagnosis; Nerve Entrapment Syndrome

Treatments: Procedure: Skin biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT05678127

NL81661.015.22

Details and patient eligibility

About

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.

Enrollment: 12 estimated patients

Sex: All

Ages: 21 to 50 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Patients with unilateral ACNES

Experimental group

Treatment:

Procedure: Skin biopsy