Anterior Cutaneous Nerve Entrapment Syndrome (ACNES)NCT01920880
Nociceptive Processing in Acute Cutaneous Nerve Entrapment Syndrome
An observational study of Anterior Cutaneous Nerve Entrapment Syndrome (ACNES), run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
Rationale: Chronic abdominal pain is a frequently occurring condition. Although hardly ever considered, the abdominal wall is the primary cause in 10-30% of cases. Most often it is caused by entrapment of an intercostal nerve in the anterior rectus sheath, the Anterior Cutaneous Nerve Entrapment Syndrome (ACNES). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anterior Cutaneous Nerve Entrapment Syndrome (ACNES)
- What is being tested?
- Quantitative Sensory Testing analysis
- How many people
- 50 participants
- Where
- 1 siteNetherlands
- Study dates
- Jun 2013to Sep 2014
- 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: Study population will consist of ACNES patients that have been treated both successfully and refractory. The control group will consist of demographically equal healthy controls from an existing database
Who may be able to join
- Patient has been diagnosed with abdominal complaints, matching ACNES:
- Patient had a constant site of tenderness that is superficially located with a small (<2cm2) area of maximal tenderness.
- The most intense pain could be localized with the tip of one finger.
- Tenderness increased by abdominal muscle tensing (Carnett's test).
- has been treated (successfully and unsuccessfully) for ACNES.
- Patient is at least 18 years old on the day the informed consent form will be signed.
- Patient is willing and able to comply with the trial protocol.
- Patient is able to speak, read and understand the local language of the investigational site, is familiar with the procedures of the study, and agrees to participate in the study program by giving oral and written informed consent prior to screening evaluations.
Who cannot join
- Abdominal complaints were due to a condition other than ACNES (e.g. pain related to scar tissue).
- Patient has (a history of) another (chronic) pain syndrome that interferes with the interpretation of QST results.
- Patient has (a history of) Raynaud syndrome or fenomenon, or a medical disorder that interferes with the study measurements or may pose a risk for the patient.
- Patient does not feel a pinprick test to the lower extremities, due to affected sensory input (e.g. neuropathy as a result of diabetes mellitus).
- Female patient is pregnant during the course of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nociceptive Processing in Acute Cutaneous Nerve Entrapment Syndrome: a Quantitative Sensory Testing Analysis.
Rationale: Chronic abdominal pain is a frequently occurring condition. Although hardly ever considered, the abdominal wall is the primary cause in 10-30% of cases. Most often it is caused by entrapment of an intercostal nerve in the anterior rectus sheath, the Anterior Cutaneous Nerve Entrapment Syndrome (ACNES). Treatment consists of local anaesthetic injections combined with methyl-prednisolon. When ineffective, a neurectomy at the site of penetration out of the ventral rectus sheet should be considered. This neurectomy however is effective in 73% of cases, leaving some 25% of patients in pain. Whether these refractory ACNES patients suffer from underlying pathologic pain disorders is subject to investigation, by using quantitative sensory testing (QST).
Objective: To investigate nociceptive processing and possible underlying pathological pain processing mechanisms in ACNES patients.
Read more
Study design: An observational case-control study.
Study population: Patients treated for ACNES (n = 50) compared to healthy controls from an existing database.
Measurements: Quantitative sensory testing (QST) of nociception, performed after treatment of ACNES for both successfully treated and refractory patients in comparison to healthy controls. Visual Analogue Scores (VAS) measured before, during and after testing procedures. Pain Anxiety Symptom Scale (PASS) and Pain Catastrophizing Scale (PCS) questionnaires.
Main study parameters: Pressure pain and electrical pain thresholds as investigated by QST. Secondary study parameters are VAS-scores and results of PASS and PCS questionnaires.
- Being tested
- Quantitative Sensory Testing analysis
- Keywords
- Anterior cutaneous nerve entrapment syndrome, ACNES, chronic abdominal wall pain, CAWP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quantitative Sensory Testing analysisOther
| Study group | Role | What they receive |
|---|---|---|
| ACNES patients | Patients being treated in past for anterior cutaneous nerve entrapment syndrome Receives: Other: Quantitative Sensory Testing analysis | |
| Healthy controls | Healthy controls Receives: Other: Quantitative Sensory Testing analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
pressure pain threshold
The pressure pain threshold (pPT) will be determined by pressing an electronic pressure algometer, which has a surface area of 1 cm2, on a distinct muscles. The patient will be asked to say 'now' when the sensation is rated as unpleasant. The pressure will be increased at a rate of 50 kPa/sec until the pPT is reached.
Measured: > 6 weeks after treatment
Secondary outcomes (5)
Electrical Sensation Threshold (eST)
Electrical QST will be measured using a computerized electric stimulation device delivering constant current skin stimulation via self-adhesive electrodes.
Electric sensation threshold (eST): when electric sensation is first felt.
Measured: > 6 weeks after treatment
Electrical Pain Threshold (ePT)
Electrical QST will be measured using a computerized electric stimulation device delivering constant current skin stimulation via self-adhesive electrodes.
Electric pain threshold (ePT): when electric sensation is rated as unpleasant
Measured: > 6 weeks after treatment
Electrical Pain Tolerance Threshold (ePTT)
Electrical QST will be measured using a computerized electric stimulation device delivering constant current skin stimulation via self-adhesive electrodes.
Electric pain tolerance threshold (ePTT): when electric sensation is intolerable.
Measured: >6 weeks after treatment
Electric Wind-Up Response (e-WUR)
Electrical QST will be measured using a computerized electric stimulation device delivering constant current skin stimulation via self-adhesive electrodes.
Electric wind-up response (eWUR): rated pain after repeated stimuli
Measured: > 6 weeks after treatment
Visual Analogue Scale
Patients will be asked to mark on a 100mm VAS line the average pain in a pain diary. The boundaries of these lines are "no pain" on the upper left site and "unbearable pain" on the upper right site.
Measured: > 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 posted12 Aug 2013 (estimated)
- Study startJun 2013
- Primary completionMay 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anterior Cutaneous Nerve Entrapment Syndrome (ACNES)Studies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- H. van Goor, Prof. MD, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01920880
- Sponsor's protocol ID
- NL43583.091.13
- Status last verified
- Nov 2014
- First submitted
- 12 Jul 2013
- Last updated
- 17 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
van Rijckevorsel DC, Boelens OB, Roumen RM, Wilder-Smith OH, van Goor H. Treatment response and central pain processing in Anterior Cutaneous Nerve Entrapment Syndrome: An explorative study. Scand J Pain. 2017 Jan;14:53-59. doi: 10.1016/j.sjpain.2016.09.014. Epub 2016 Nov 4.
PubMed 28850430
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nociceptive Processing in Acute Cutaneous Nerve Entrapment Syndrome: a Quantitative Sensory Testing Analysis.
- ClinicalTrials.gov ID
- NCT01920880
- Acronym / sponsor ID
- NL43583.091.13
- Keywords
- Anterior cutaneous nerve entrapment syndrome, ACNES, chronic abdominal wall pain, CAWP
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- May 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 12 Aug 2013 (estimated)
- 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.
Rationale: Chronic abdominal pain is a frequently occurring condition. Although hardly ever considered, the abdominal wall is the primary cause in 10-30% of cases. Most often it is caused by entrapment of an intercostal nerve in the anterior rectus sheath, the Anterior Cutaneous Nerve Entrapment Syndrome (ACNES). Treatment consists of local anaesthetic injections combined with methyl-prednisolon. When ineffective, a neurectomy at the site of penetration out of the ventral rectus sheet should be considered. This neurectomy however is effective in 73% of cases, leaving some 25% of patients in pain. Whether these refractory ACNES patients suffer from underlying pathologic pain disorders is subject to investigation, by using quantitative sensory testing (QST).
Objective: To investigate nociceptive processing and possible underlying pathological pain processing mechanisms in ACNES patients.
Study design: An observational case-control study.
Study population: Patients treated for ACNES (n = 50) compared to healthy controls from an existing database.
Measurements: Quantitative sensory testing (QST) of nociception, performed after treatment of ACNES for both successfully treated and refractory patients in comparison to healthy controls. Visual Analogue Scores (VAS) measured before, during and after testing procedures. Pain Anxiety Symptom Scale (PASS) and Pain Catastrophizing Scale (PCS) questionnaires.
Main study parameters: Pressure pain and electrical pain thresholds as investigated by QST. Secondary study parameters are VAS-scores and results of PASS and PCS questionnaires.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACNES patients | – | Other: Quantitative Sensory Testing analysisPatients being treated in past for anterior cutaneous nerve entrapment syndrome |
| Healthy controls | – | Other: Quantitative Sensory Testing analysisHealthy controls |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study population will consist of ACNES patients that have been treated both successfully and refractory. The control group will consist of demographically equal healthy controls from an existing database
Key inclusion criteria (8 listed)
- Patient has been diagnosed with abdominal complaints, matching ACNES:
- has been treated (successfully and unsuccessfully) for ACNES.
- Patient is at least 18 years old on the day the informed consent form will be signed.
- Patient is willing and able to comply with the trial protocol.
- Patient is able to speak, read and understand the local language of the investigational site, is familiar with the procedures of the study, and agrees to participate in the study program by giving oral and written informed consent prior to screening evaluations.
Key exclusion criteria (5 listed)
- Abdominal complaints were due to a condition other than ACNES (e.g. pain related to scar tissue).
- Patient has (a history of) another (chronic) pain syndrome that interferes with the interpretation of QST results.
- Patient has (a history of) Raynaud syndrome or fenomenon, or a medical disorder that interferes with the study measurements or may pose a risk for the patient.
- Patient does not feel a pinprick test to the lower extremities, due to affected sensory input (e.g. neuropathy as a result of diabetes mellitus).
- Female patient is pregnant during the course of the study.
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 |
|---|---|---|
| Quantitative Sensory Testing analysis | Other | ACNES patients, Healthy controls |
Primary outcome
pressure pain threshold
Time frame: > 6 weeks after treatment
The pressure pain threshold (pPT) will be determined by pressing an electronic pressure algometer, which has a surface area of 1 cm2, on a distinct muscles. The patient will be asked to say 'now' when the sensation is rated as unpleasant. The pressure will be increased at a rate of 50 kPa/sec until the pPT is reached.
5 secondary outcomes
Electrical Sensation Threshold (eST)
Time frame: > 6 weeks after treatment
Electrical Pain Threshold (ePT)
Time frame: > 6 weeks after treatment
Electrical Pain Tolerance Threshold (ePTT)
Time frame: >6 weeks after treatment
Electric Wind-Up Response (e-WUR)
Time frame: > 6 weeks after treatment
Visual Analogue Scale
Time frame: > 6 weeks after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2014.
- Derived from this study: PubMed 28850430van Rijckevorsel DC, Boelens OB, Roumen RM, Wilder-Smith OH, van Goor H. Treatment response and central pain processing in Anterior Cutaneous Nerve Entrapment Syndrome: An explorative study. Scand J Pain. 2017 Jan;14:53-59. doi: 10.1016/j.sjpain.2016.09.014. Epub 2016 Nov 4.
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.
H. van Goor, Prof. MD principal investigator
Radboud University 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 (ACNES), run by Radboud University 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 8 inclusion and 5 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: finished, as of the sponsor's last update on 17 Nov 2014. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pressure pain threshold (time frame: > 6 weeks after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01920880, which also lists 1 linked publication.
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 17 Nov 2014; AzTrials last refreshed its copy on 31 Oct 2026.