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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with unilateral ACNES | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Skin biopsy | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Duration of pain |
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Inclusion Criteria:
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;
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tom ten Have, MD | Contact | +31408887461 | Tom.ten.Have@mmc.nl |
| Name | Affiliation | Role |
|---|---|---|
| Rudi Roumen, MD, PhD | Maxima Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maxima Medical Center | Recruiting | Veldhoven | 5504 DB | Netherlands |
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Skin biopsies will be performed on patients with an unilateral ACNES. Biopsies will be taken at the triggerpoint (affected side) and contralateral, non-affected side of the abdominal wall.
Affected vs non-affected will be compared. The non-affected side serves as control.
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The pathologists who will measure the nerve fibre density are blinded; they will not know if the biopsy is from the affected or non-affected side.
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|
Duration of pain in months before diagnosis
| Assessed at first outpatient visit, used as baseline data. |
| 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. |
| ID | Term |
|---|---|
| D002607 | Charcot-Marie-Tooth Disease |
| D004194 | Disease |
| ID | Term |
|---|---|
| D015417 | Hereditary Sensory and Motor Neuropathy |
| D009421 | Nervous System Malformations |
| D009422 | Nervous System Diseases |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D011115 | Polyneuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D030342 | Genetic Diseases, Inborn |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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