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

Diagnosis Clinical Trial

— Biopsy-ACNES  

Official title:

Skin Biopsy as Diagnostic Tool in Anterior Cutaneous Nerve Entrapment Syndrome (ACNES): A Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05678127
• Other study ID #: NL81661.015.22
• Status: Recruiting
• Phase: N/A
• Start date: May 24, 2023
• Est. completion date: December 2023

Study information

• Verified date: May 2023
• Source: Maxima Medical Center
• Contact: Tom ten Have, MD
• Phone: +31408887461
• Email: Tom.ten.Have[@]mmc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: December 2023
• Est. primary completion date: November 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 50 Years

Eligibility

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)

Related Conditions & MeSH terms

• Charcot-Marie-Tooth Disease
• Chronic Pain
• Chronic Pain Syndrome
• Diagnosis
• Hereditary Sensory and Motor Neuropathy
• Nerve Compression Syndromes
• Nerve Entrapment Syndrome
• Syndrome

Intervention

Procedure:
• Skin biopsy
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.

Locations

Country	Name	City	State
Netherlands	Maxima Medical Center	Veldhoven

Sponsors (1)

Lead Sponsor	Collaborator
Maxima Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pain score	Average pain score, assessed using the Numeric Rating Scale (NRS) 0-10 before start of treatment. 0 no pain, 10 worst possible pain.	Assessed at first outpatient visit, used as baseline data.
Secondary	Duration of pain	Duration of pain in months before diagnosis	Assessed at first outpatient visit, used as baseline data.
Secondary	Treatment response	Patients will receive standard of care treatment for ACNES. Treatment is unsuccessful if <50% pain reduction or when patients are not satisfied with their pain relief and want additional treatment.	Treatment response will be assessed 2 to 6 weeks after each treatment (trigger point injections, PRF and neurectomy), as standard of care.