Completed

NCT Number: NCT03574727

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.

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Key information

Conditions

Abdominal Pain Abdominal Cutaneous Nerve Entrapment Syndrome Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Aberdeen Royal Infirmary

Aberdeen, Scotland, AB25 2 ZN, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Patients will be excluded if they:

Are not able to understand what is required of them
Are not able to give informed consent

Treatment and study plan

Injection to or release of anterior cutaneous nerves

Procedure

Patients who have undergone at least one injection to the nerves

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

University of Aberdeen

Other

Collaborators

NHS Grampian

Registry information

Official study title

The Management of Abdominal Cutaneous Nerve Entrapment Syndrome

Acronym: ACNES

Important dates

Study start: 2017
Primary completion: 2018
Study completion: 2018
First posted: Jul 2, 2018
Registry last updated: Dec 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed