ACNES: Abdominal Cutaneous Nerve Entrapment Syndrome

• Sponsor: University of Aberdeen (Other)
• Overall Status: Completed
• CT.gov ID: NCT03574727
• Collaborator: NHS Grampian (Other)
• Enrollment: 35
• Location: 1
• Actual Duration (Months): 12.1
• Patients Per Site Per Month: 2.9

Study Details

Study Description

Brief 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. 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.

Condition or Disease	Intervention/Treatment	Phase
Abdominal Pain; Abdominal Cutaneous Nerve Entrapment Syndrome	Procedure: Injection to or release of anterior cutaneous nerves

Study Design

• Study Type: Observational
• Actual Enrollment: 35 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: The Management of Abdominal Cutaneous Nerve Entrapment Syndrome
• Actual Study Start Date: Sep 15, 2017
• Actual Primary Completion Date: Sep 19, 2018
• Actual Study Completion Date: Sep 19, 2018

Outcome Measures

Primary Outcome Measures

1. Success rate of intervention [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Aberdeen Royal Infirmary	Aberdeen	Scotland	United Kingdom	AB25 2 ZN

Sponsors and Collaborators

• University of Aberdeen
• NHS Grampian

Investigators

• Principal Investigator: Saravanakumar Kanakarajan, MD, NHS Grampian

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Aberdeen
• ClinicalTrials.gov Identifier: NCT03574727
• Other Study ID Numbers: 2017AN003
• First Posted: Jul 2, 2018
• Last Update Posted: Sep 27, 2019
• Last Verified: Sep 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Nerve Compression Syndromes; Charcot-Marie-Tooth Disease; Hereditary Sensory and Motor Neuropathy; Syndrome; Abdominal Pain

Study Results

No Results Posted as of Sep 27, 2019