Skin Biopsy as Diagnostic Tool in Anterior Cutaneous Nerve Entrapment Syndrome (ACNES): A Pilot Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Anterior Cutaneous Nerve Entrapment Syndrome
- Sponsor
- Maxima Medical Center
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Intraepidermal Nerve Fibre density (IENFD)
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
dr. RMH Roumen, surgeon
Head of surgery, Principal Investigator
Maxima Medical Center
Eligibility Criteria
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;
- •Hypothyroidism
Outcomes
Primary Outcomes
Intraepidermal Nerve Fibre density (IENFD)
Time Frame: 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).
Difference in IENFD (measured in IENF/mm) from both affected and non-affected side of the abdominal wall.
Secondary Outcomes
- Treatment response(Treatment response will be assessed 2 to 6 weeks after each treatment (trigger point injections, PRF and neurectomy), as standard of care.)
- Pain score(Assessed at first outpatient visit, used as baseline data.)
- Duration of pain(Assessed at first outpatient visit, used as baseline data.)