Anterior Cutaneous Nerve Entrapment SyndromeBiopsy-ACNESNCT05678127
A Pilot Study to Explore the Use of Skin Biopsy as Diagnostic Tool in Anterior Cutaneous Nerve Entrapment Syndrome (ACNES)
A study testing Skin biopsy in people with Anterior Cutaneous Nerve Entrapment Syndrome and Nerve Entrapment Syndrome, run by Maxima Medical Center at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 21 to 50 years
- Conditions the study is for
- Anterior Cutaneous Nerve Entrapment Syndrome, Nerve Entrapment Syndrome, Chronic Pain Syndrome
- What is being tested?
- Skin biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteNetherlands
- Study dates
- 24 May 2023to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Duration of pain >3 months
- Newly diagnosed unilateral ACNES
- Fully completed intake questionnaire
- Obtained written informed consent
Who cannot join
- 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
Show all 17Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Maxima Medical Center
Veldhoven, 5504 DB
Tom ten Have, MD, +31408887461, Tom.ten.Have@mmc.nl
Rudi Roumen, MD, PhD
About this study
Official title: Skin Biopsy as Diagnostic Tool in Anterior Cutaneous Nerve Entrapment Syndrome (ACNES): A Pilot Study
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.
- Conditions
- Anterior Cutaneous Nerve Entrapment Syndrome, Nerve Entrapment Syndrome, Chronic Pain Syndrome, Diagnosis
- Being tested
- Skin biopsy
- Keywords
- Diagnostic test for ACNES, Intraepidermal nerve fibre density (IENFD)
- Medical subject headings
- Charcot-Marie-Tooth Disease, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin biopsyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with unilateral ACNES | Experimental | Not described Receives: Procedure: Skin biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraepidermal Nerve Fibre density (IENFD)
Difference in IENFD (measured in IENF/mm) from both affected and non-affected side of the abdominal wall.
Measured: 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 outcomes (3)
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.
Measured: Assessed at first outpatient visit, used as baseline data.
Duration of pain
Duration of pain in months before diagnosis
Measured: 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.
Measured: Treatment response will be assessed 2 to 6 weeks after each treatment (trigger point injections, PRF and neurectomy), as standard of care.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2023
- Study start24 May 2023
- Primary completionNov 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cutaneous Nerve Entrapment SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maxima Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, dr. RMH Roumen, surgeon, Maxima Medical Center
- Investigators
- Rudi Roumen, MD, PhD, Principal investigator, Maxima Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05678127
- Sponsor's protocol ID
- NL81661.015.22
- Acronym
- Biopsy-ACNES
- Status last verified
- May 2023
- First submitted
- 29 Dec 2022
- Last updated
- 31 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skin Biopsy as Diagnostic Tool in Anterior Cutaneous Nerve Entrapment Syndrome (ACNES): A Pilot Study
- ClinicalTrials.gov ID
- NCT05678127
- Acronym / sponsor ID
- Biopsy-ACNES / NL81661.015.22
- Conditions
- Anterior Cutaneous Nerve Entrapment Syndrome, Nerve Entrapment Syndrome, Chronic Pain Syndrome, Diagnosis
- Keywords
- Diagnostic test for ACNES, Intraepidermal nerve fibre density (IENFD)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Maxima Medical CenterUniversity, hospital or other
- Study start
- 24 May 2023 (actual)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 10 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Patients with unilateral ACNES | Experimental | Procedure: Skin biopsy |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Duration of pain >3 months
- Newly diagnosed unilateral ACNES
- Fully completed intake questionnaire
- Obtained written informed consent
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Skin biopsyTwo 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. | Procedure or surgery | Patients with unilateral ACNES |
Primary outcome
Intraepidermal Nerve Fibre density (IENFD)
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).
Difference in IENFD (measured in IENF/mm) from both affected and non-affected side of the abdominal wall.
3 secondary outcomes
Pain score
Time frame: Assessed at first outpatient visit, used as baseline data.
Duration of pain
Time frame: Assessed at first outpatient visit, used as baseline data.
Treatment response
Time frame: Treatment response will be assessed 2 to 6 weeks after each treatment (trigger point injections, PRF and neurectomy), as standard of care.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Anterior Cutaneous Nerve Entrapment Syndrome
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Anterior Cutaneous Nerve Entrapment Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rudi Roumen, MD, PhD principal investigator
Maxima Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Skin biopsy in people with Anterior Cutaneous Nerve Entrapment Syndrome and Nerve Entrapment Syndrome, run by Maxima Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tom ten Have, MD (+31408887461, Tom.ten.Have@mmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraepidermal Nerve Fibre density (IENFD) (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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2023.