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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05678127
Other study ID # NL81661.015.22
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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)

Study Design


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.
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