Abdominal PainACNESNCT03574727
Abdominal Cutaneous Nerve Entrapment Syndrome
An observational study of Abdominal Pain and Abdominal Cutaneous Nerve Entrapment Syndrome, run by University of Aberdeen at 1 site in United Kingdom.
Trial summary
Nerve entrapment as a cause of chronic abdominal pain is frequently overlooked. A series of nerves pass through the muscles of the abdomen before reaching the skin to carry sensations. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Abdominal Pain, Abdominal Cutaneous Nerve Entrapment Syndrome
- What is being tested?
- Injection to or release of anterior cutaneous nerves
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 35 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Sep 2017to 19 Sep 2018
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Potential participants will be identified from the hospital electronic booking system. A list of patients between January 2010 and December 2015 and had injection for chronic abdominal wall pain will be invited for the study.
Who may be able to join
- In order to be eligible for inclusion, all patients must:
- Be aged 16 or over
- Be able to understand English
- Be able to give informed consent
- Be able to report on their health and pain status (neurologically stable)
- Should have undergone either injection or surgery for suspected ACNES
Who cannot join
- Patients will be excluded if they:
- Are not able to understand what is required of them
- Are not able to give informed consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Aberdeen Royal Infirmary
Aberdeen, Scotland, AB25 2 ZN
About this study
Official title: The Management of Abdominal Cutaneous Nerve Entrapment Syndrome
Nerve entrapment as a cause of chronic abdominal pain is frequently overlooked. A series of nerves pass through the muscles of the abdomen before reaching the skin to carry sensations. They can get trapped within the muscles leading to severe pain resulting in a condition known as Abdominal Cutaneous Nerve Entrapment Syndrome (ACNES). ACNES affects between 10-30% of patients with chronic abdominal wall pain. A definitive diagnosis of ACNES is obtained by anaesthetising these nerves. Initial management includes education and avoidance of known triggers. It is common practice to inject steroid with local anaesthetic during the diagnostic injections itself to prolong pain relief. Like other nerve entrapment conditions, this is also refractory to medical treatment. Hence repeated injections and nerve entrapment release surgery are commonly carried out.
In Aberdeen, a number of patients have been treated for this condition. A cohort of patients have benefitted with injection alone while recurrence has been noted in patients who have undergone surgery. This project aims to gain more understanding about the clinical course of patients with suspected ACNES by evaluation of the clinic progress.
Read the detailed description
This is a cross-sectional survey, best suited to evaluate the effect of treatments. Potential participants will be identified from a list of patients who have attended the pain clinic at Aberdeen Royal Infirmary for chronic abdominal wall pain.
These patients will be invited to participate in the study via posted letter. The letter will include a participant information sheet detailing who is running the study, what the purpose of the study is, what participating in the study requires of a patient and how their information will be used.
Patients who wish to participate will return a note of interest, included within the participant information pack, and will then be invited to attend an outpatient clinic in the Aberdeen Health Care and Community Village. Informed consent will be obtained. The questionnaire will be distributed. It is estimated that the questionnaire will take approximately 15 minutes to complete. Each completed questionnaire will be reviewed immediately by a member of the research team to ensure all relevant sections have been completed. Following completion of the questionnaire, patients will be allowed to leave. It is not anticipated that participants will need to be contacted after submitting their completed questionnaire. Participants who explicit express the need for further pain management will be referred to NHS Grampian pain clinic.
A response from potential participants will be awaited for 4 weeks. In the event of no response, a maximum of 2 written reminders 4 weeks apart will be sent along with participant information pack.
The questionnaires have previously been validated for use in neuropathic pain, and the outcomes of the questionnaire are consistent with those recommended by the 2008 Initiative on Methods, Measurement and Pain Assessment in Clinical Trials (IMMPACT) publication. 17
The questionnaire will consist of four main sections: baseline demographic details, a detailed pain history prior to surgery, including questions from the Brief Pain Inventory, 18 open-ended questions to explore the patient's opinions of both the operation and their health status since and, finally, an overall picture of health using the European Quality of Life-5 Dimensions (EQ-5D) Score 19 and patient global impression of change scale. 20
In order to compare pain both before and after surgery, participants will be asked to complete these sections twice, focusing on their previous health state and their current health.
Since pain scores are not routinely collected and all patients will be seen after surgery, pre-operative pain scores will be retrospective.
- Being tested
- Injection to or release of anterior cutaneous nerves
- Medical subject headings
- Abdominal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injection to or release of anterior cutaneous nervesProcedure or surgery
Patients who have undergone at least one injection to the nerves
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of intervention
An intervention either injection or surgery is classed as success when there is either a 2 point difference in the average pain scores pre and post intervention or more than 30% improvement as rated by the participant in the Brief Pain Inventory used for evaluating the pain baseline and follow-up.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2018
- Study start15 Sep 2017
- Primary completion19 Sep 2018
- Study completion19 Sep 2018
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 Abdominal PainStudies 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
- Retrospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aberdeen
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Grampian
- Responsible party
- Sponsor
- Investigators
- Saravanakumar Kanakarajan, MD, Principal investigator, NHS Grampian
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03574727
- Sponsor's protocol ID
- 2017AN003
- Acronym
- ACNES
- Status last verified
- Dec 2024
- First submitted
- 20 Jun 2018
- Last updated
- 24 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kanakarajan S, Dharmavaram S, Tadros A, Pushparaj H, Rose A. Abdominal cutaneous nerve entrapment syndrome: A cross sectional survey of treatment outcomes. Br J Pain. 2022 Oct;16(5):538-545. doi: 10.1177/20494637221101719. Epub 2022 May 20.
PubMed 36389004
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Management of Abdominal Cutaneous Nerve Entrapment Syndrome
- ClinicalTrials.gov ID
- NCT03574727
- Acronym / sponsor ID
- ACNES / 2017AN003
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of AberdeenUniversity, hospital or other
- Collaborators
- NHS Grampian
- Study start
- 15 Sep 2017 (actual)
- Primary completion
- 19 Sep 2018 (actual)
- Study completion
- 19 Sep 2018 (actual)
- First posted
- 2 Jul 2018 (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.
Nerve entrapment as a cause of chronic abdominal pain is frequently overlooked. A series of nerves pass through the muscles of the abdomen before reaching the skin to carry sensations. They can get trapped within the muscles leading to severe pain resulting in a condition known as Abdominal Cutaneous Nerve Entrapment Syndrome (ACNES). ACNES affects between 10-30% of patients with chronic abdominal wall pain. A definitive diagnosis of ACNES is obtained by anaesthetising these nerves. Initial management includes education and avoidance of known triggers. It is common practice to inject steroid with local anaesthetic during the diagnostic injections itself to prolong pain relief. Like other nerve entrapment conditions, this is also refractory to medical treatment. Hence repeated injections and nerve entrapment release surgery are commonly carried out.
In Aberdeen, a number of patients have been treated for this condition. A cohort of patients have benefitted with injection alone while recurrence has been noted in patients who have undergone surgery. This project aims to gain more understanding about the clinical course of patients with suspected ACNES by evaluation of the clinic progress.
Detailed description
This is a cross-sectional survey, best suited to evaluate the effect of treatments. Potential participants will be identified from a list of patients who have attended the pain clinic at Aberdeen Royal Infirmary for chronic abdominal wall pain.
These patients will be invited to participate in the study via posted letter. The letter will include a participant information sheet detailing who is running the study, what the purpose of the study is, what participating in the study requires of a patient and how their information will be used.
Patients who wish to participate will return a note of interest, included within the participant information pack, and will then be invited to attend an outpatient clinic in the Aberdeen Health Care and Community Village. Informed consent will be obtained. The questionnaire will be distributed. It is estimated that the questionnaire will take approximately 15 minutes to complete. Each completed questionnaire will be reviewed immediately by a member of the research team to ensure all relevant sections have been completed. Following completion of the questionnaire, patients will be allowed to leave. It is not anticipated that participants will need to be contacted after submitting their completed questionnaire. Participants who explicit express the need for further pain management will be referred to NHS Grampian pain clinic.
A response from potential participants will be awaited for 4 weeks. In the event of no response, a maximum of 2 written reminders 4 weeks apart will be sent along with participant information pack.
The questionnaires have previously been validated for use in neuropathic pain, and the outcomes of the questionnaire are consistent with those recommended by the 2008 Initiative on Methods, Measurement and Pain Assessment in Clinical Trials (IMMPACT) publication. 17
The questionnaire will consist of four main sections: baseline demographic details, a detailed pain history prior to surgery, including questions from the Brief Pain Inventory, 18 open-ended questions to explore the patient's opinions of both the operation and their health status since and, finally, an overall picture of health using the European Quality of Life-5 Dimensions (EQ-5D) Score 19 and patient global impression of change scale. 20
In order to compare pain both before and after surgery, participants will be asked to complete these sections twice, focusing on their previous health state and their current health.
Since pain scores are not routinely collected and all patients will be seen after surgery, pre-operative pain scores will be retrospective.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Potential participants will be identified from the hospital electronic booking system. A list of patients between January 2010 and December 2015 and had injection for chronic abdominal wall pain will be invited for the study.
Key inclusion criteria (6 listed)
- Be aged 16 or over
- Be able to understand English
- Be able to give informed consent
- Be able to report on their health and pain status (neurologically stable)
- Should have undergone either injection or surgery for suspected ACNES
Key exclusion criteria (3 listed)
- Are not able to understand what is required of them
- Are not able to give informed consent
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 |
|---|---|---|
| Injection to or release of anterior cutaneous nervesPatients who have undergone at least one injection to the nerves | Procedure or surgery | – |
Primary outcome
Success rate of intervention
Time frame: 3 months
An intervention either injection or surgery is classed as success when there is either a 2 point difference in the average pain scores pre and post intervention or more than 30% improvement as rated by the participant in the Brief Pain Inventory used for evaluating the pain baseline and follow-up.
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 24 Dec 2024.
- Background: PubMed 36389004Kanakarajan S, Dharmavaram S, Tadros A, Pushparaj H, Rose A. Abdominal cutaneous nerve entrapment syndrome: A cross sectional survey of treatment outcomes. Br J Pain. 2022 Oct;16(5):538-545. doi: 10.1177/20494637221101719. Epub 2022 May 20.
- National Library of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Saravanakumar Kanakarajan, MD principal investigator
NHS Grampian
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 Abdominal Pain and Abdominal Cutaneous Nerve Entrapment Syndrome, run by University of Aberdeen at 1 site in United Kingdom.
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 6 inclusion and 3 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 24 Dec 2024. 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 United Kingdom. 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?
Success rate of intervention (time frame: 3 months). 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 NCT03574727, 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 24 Dec 2024.