A Pilot Study to Explore the Use of Skin Biopsy as Diagnostic Tool in Anterior Cutaneous Nerve Entrapment Syndrome (ACNES)
Unknown statusNot applicableNCT05678127
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Skin Biopsy as Diagnostic Tool in Anterior Cutaneous Nerve Entrapment Syndrome (ACNES): A Pilot Study
- Conditions
- Anterior Cutaneous Nerve Entrapment Syndrome
- Nerve Entrapment Syndrome
- Chronic Pain Syndrome
- Diagnosis
- Interventions
- Procedure: Skin biopsy
- Sponsor
- Maxima Medical Center
- Start date
- 2023-05-24
- Primary completion
- 2023-11
- Sex
- All
- Age range
- from 21 Years to 50 Years
- Results posted
- No results posted in this snapshot
- Countries
- Netherlands
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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)
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05678127