Back to resultsA Pilot Study to Explore the Use of Skin Biopsy as Diagnostic Tool in Anterior Cutaneous Nerve Entrapment Syndrome (ACNES) (Biopsy-ACNES)
Primary Purpose
Anterior Cutaneous Nerve Entrapment Syndrome, Nerve Entrapment Syndrome, Chronic Pain Syndrome
Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Skin biopsy
Sponsored by
About this trial
This is an interventional diagnostic trial for Anterior Cutaneous Nerve Entrapment Syndrome focused on measuring Diagnostic test for ACNES, Intraepidermal nerve fibre density (IENFD)
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; Diabetes Hypothyroidism Renal failure Vitamin B12 deficiency Monoclonal gammopathy Alcohol abuse (>5 IU a day) Malignancies Medication that cause neuropathy (for example chemotherapy)
Sites / Locations
- Maxima Medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients with unilateral ACNES
Arm Description
Outcomes
Primary Outcome Measures
Intraepidermal Nerve Fibre density (IENFD)
Difference in IENFD (measured in IENF/mm) from both affected and non-affected side of the abdominal wall.
Secondary Outcome Measures
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.
Duration of pain
Duration of pain in months before diagnosis
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05678127
Brief Title
A Pilot Study to Explore the Use of Skin Biopsy as Diagnostic Tool in Anterior Cutaneous Nerve Entrapment Syndrome (ACNES)
Acronym
Biopsy-ACNES
Official Title
Skin Biopsy as Diagnostic Tool in Anterior Cutaneous Nerve Entrapment Syndrome (ACNES): A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 24, 2023 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Maxima Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Cutaneous Nerve Entrapment Syndrome, Nerve Entrapment Syndrome, Chronic Pain Syndrome, Diagnosis
Keywords
Diagnostic test for ACNES, Intraepidermal nerve fibre density (IENFD)
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Masking Description
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.
Allocation
N/A
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients with unilateral ACNES
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Skin biopsy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Intraepidermal Nerve Fibre density (IENFD)
Description
Difference in IENFD (measured in IENF/mm) from both affected and non-affected side of the abdominal wall.
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).
Secondary Outcome Measure Information:
Title
Pain score
Description
Average pain score, assessed using the Numeric Rating Scale (NRS) 0-10 before start of treatment. 0 no pain, 10 worst possible pain.
Time Frame
Assessed at first outpatient visit, used as baseline data.
Title
Duration of pain
Description
Duration of pain in months before diagnosis
Time Frame
Assessed at first outpatient visit, used as baseline data.
Title
Treatment response
Description
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.
Time Frame
Treatment response will be assessed 2 to 6 weeks after each treatment (trigger point injections, PRF and neurectomy), as standard of care.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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;
Diabetes
Hypothyroidism
Renal failure
Vitamin B12 deficiency
Monoclonal gammopathy
Alcohol abuse (>5 IU a day)
Malignancies
Medication that cause neuropathy (for example chemotherapy)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tom ten Have, MD
Phone
+31408887461
Email
Tom.ten.Have@mmc.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rudi Roumen, MD, PhD
Organizational Affiliation
Maxima Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maxima Medical Center
City
Veldhoven
ZIP/Postal Code
5504 DB
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tom ten Have, MD
Phone
+31408887461
Email
Tom.ten.Have@mmc.nl
First Name & Middle Initial & Last Name & Degree
Rudi Roumen, MD, PhD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
A Pilot Study to Explore the Use of Skin Biopsy as Diagnostic Tool in Anterior Cutaneous Nerve Entrapment Syndrome (ACNES)
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