Anterior Cutaneous Nerve Entrapment SyndromeNav-ACNESNCT05877274
Sodium Channel Mutations in Patient With the Anterior Cutaneous Nerve Entrapment Syndrome (ACNES)
An observational study of Anterior Cutaneous Nerve Entrapment Syndrome and Nerve Entrapment Syndrome, run by Maxima Medical Center at 1 site in Netherlands.
Trial summary
The goal of this observational study is to learn about sodium channel (Nav) mutations in patients with the Anterior Cutaneous Nerve Entrapment Syndrome (ACNES). This study will give more insight into the pathophysiology of ACNES, which is still largely unknown. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anterior Cutaneous Nerve Entrapment Syndrome, Nerve Entrapment Syndrome, Chronic Pain Syndrome
- What is being tested?
- Sodium channel mutation
- How many people
- 50 participants
- Where
- 1 siteNetherlands
- Study dates
- 3 Oct 2023to Dec 2024
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients who are diagnosed with ACNES and receive treatment at our outpatient clinic, and fulfill the inclusion criteria.
Who may be able to join
- In order to be eligible to participate in this study, a subject must be diagnosed with ACNES and receive treatment at our outpatient clinic. Additionally, subject has to meet one of the following criteria:
- Known to have a first- or second-degree relative with ACNES;
- Have more than one recurrence of ACNES after a pain free period or ACNES at multiple locations in the abdominal wall;
- Persistent pain after posterior neurectomy.
Who cannot join
- Inability to understand Dutch language.
- Known neuromuscular or neurodegenerative disease.
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: Sodium Channel Mutations (SCN9A, SCN10A) in the Anterior Cutaneous Nerve Entrapment Syndrome (ACNES)
The goal of this observational study is to learn about sodium channel (Nav) mutations in patients with the Anterior Cutaneous Nerve Entrapment Syndrome (ACNES). This study will give more insight into the pathophysiology of ACNES, which is still largely unknown.
The primary objective is to determine if there are mutations of Nav1.7 and Nav1.8 in patients with ACNES. Therefore, one blood sample will be drawn, in which the mutations will be analyzed.
- Conditions
- Anterior Cutaneous Nerve Entrapment Syndrome, Nerve Entrapment Syndrome, Chronic Pain Syndrome
- Being tested
- Sodium channel mutation
- Keywords
- ACNES, Sodium channel mutations
- Medical subject headings
- Charcot-Marie-Tooth Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium channel mutationOther
Mutation of the genes SCN9A and SCN10A, which encode for Sodium channel 1.7 and 1.8.
| Study group | Role | What they receive |
|---|---|---|
| Patients with ACNES | Patients with ACNES who fulfill the inclusion criteria. Receives: Other: Sodium channel mutation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sodium Channel 1.7 and 1.8 mutation.
Number of SCN9A and SCN10A mutations. Each mutation will be classified following one of three classes; unknown pathogenicity, probable pathogenicity, and pathogen variant.
Measured: Blood samples for SCN analysis will be taken only once after obtaining informed consent. This is the start of the study. Outpatient discharge (free of pain or no treatment options) is end of study. Treatment period can be a couple of weeks or months.
Secondary outcomes (3)
Correlation between mutations and known cause of ACNES.
Patients are asked (standard of care) if there is a possible cause of the ACNES. Correlations between the causes of ACNES and any identified mutations will be examined.
Measured: Baseline data will be obtained during first outpatient visit, before start of the treatment. The first outpatient visit takes 30 minutes (standard of care).
Correlation between mutations and pain score at start of treatment.
Patients are asked (standard of care) about the average pain score following the 0-10 numeric rating scale (NRS) (0 = no pain, 10 worst possible pain).
Correlations between the NRS pain score and found mutations will be examined.
Measured: Baseline data will be obtained during first outpatient visit, before start of the treatment. The first outpatient visit takes 30 minutes (standard of care).
Correlation between mutations and treatment response.
Patients follow different treatments according standard of care for ACNES. Starting with trigger point injections with a local anesthetic, if this treatment is not sufficient, it is followed by Pulse Radiofrequency. When patients still experience pain after minimal invasive treatments, a surgical neurectomy is performed.
Correlations between treatment outcome after the different treatment options and found mutations will be examined. Treatment is defined successful if the patient does not need additional treatment, has >50% pain reduction, or reduction of >4 NRS points.
Measured: Treatment response will be assessed after each treatment during the treatment period at our outpatient clinic, up to 6 weeks after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2023
- Study start3 Oct 2023
- Primary completionJun 2024 (estimated)
- Study completionDec 2024 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 50 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
- NCT05877274
- Sponsor's protocol ID
- NL84021.015.23
- Acronym
- Nav-ACNES
- Status last verified
- May 2023
- First submitted
- 16 Apr 2023
- Last updated
- 30 Oct 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 30 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sodium Channel Mutations (SCN9A, SCN10A) in the Anterior Cutaneous Nerve Entrapment Syndrome (ACNES)
- ClinicalTrials.gov ID
- NCT05877274
- Acronym / sponsor ID
- Nav-ACNES / NL84021.015.23
- Conditions
- Anterior Cutaneous Nerve Entrapment Syndrome, Nerve Entrapment Syndrome, Chronic Pain Syndrome
- Keywords
- ACNES, Sodium channel mutations
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Maxima Medical CenterUniversity, hospital or other
- Study start
- 3 Oct 2023 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 26 May 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.
The goal of this observational study is to learn about sodium channel (Nav) mutations in patients with the Anterior Cutaneous Nerve Entrapment Syndrome (ACNES). This study will give more insight into the pathophysiology of ACNES, which is still largely unknown.
The primary objective is to determine if there are mutations of Nav1.7 and Nav1.8 in patients with ACNES. Therefore, one blood sample will be drawn, in which the mutations will be analyzed.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with ACNES | – | Other: Sodium channel mutationPatients with ACNES who fulfill the inclusion criteria. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who are diagnosed with ACNES and receive treatment at our outpatient clinic, and fulfill the inclusion criteria.
Key inclusion criteria (4 listed)
- In order to be eligible to participate in this study, a subject must be diagnosed with ACNES and receive treatment at our outpatient clinic. Additionally, subject has to meet one of the following criteria:
- Known to have a first- or second-degree relative with ACNES;
- Have more than one recurrence of ACNES after a pain free period or ACNES at multiple locations in the abdominal wall;
- Persistent pain after posterior neurectomy.
Key exclusion criteria (2 listed)
- Inability to understand Dutch language.
- Known neuromuscular or neurodegenerative disease.
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 |
|---|---|---|
| Sodium channel mutationMutation of the genes SCN9A and SCN10A, which encode for Sodium channel 1.7 and 1.8. | Other | Patients with ACNES |
Primary outcome
Sodium Channel 1.7 and 1.8 mutation.
Time frame: Blood samples for SCN analysis will be taken only once after obtaining informed consent. This is the start of the study. Outpatient discharge (free of pain or no treatment options) is end of study. Treatment period can be a couple of weeks or months.
Number of SCN9A and SCN10A mutations. Each mutation will be classified following one of three classes; unknown pathogenicity, probable pathogenicity, and pathogen variant.
3 secondary outcomes
Correlation between mutations and known cause of ACNES.
Time frame: Baseline data will be obtained during first outpatient visit, before start of the treatment. The first outpatient visit takes 30 minutes (standard of care).
Correlation between mutations and pain score at start of treatment.
Time frame: Baseline data will be obtained during first outpatient visit, before start of the treatment. The first outpatient visit takes 30 minutes (standard of care).
Correlation between mutations and treatment response.
Time frame: Treatment response will be assessed after each treatment during the treatment period at our outpatient clinic, up to 6 weeks after treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2023.
- Individual participant dataSharing planned: Undecided
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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?
An observational study of 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 2 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 30 Oct 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 (0408887461, 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?
Sodium Channel 1.7 and 1.8 mutation. (time frame: Blood samples for SCN analysis will be taken only once after obtaining informed consent. This is the start of the study. Outpatient discharge (free of pain or no treatment options) is end of study. Treatment period can be a couple of weeks or months.). 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 30 Oct 2023.