NCT03574727

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2017

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 20, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 2, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 19, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 19, 2018

Completed
Last Updated

December 24, 2024

Status Verified

December 1, 2024

Enrollment Period

1 year

First QC Date

June 20, 2018

Last Update Submit

December 18, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 months

Interventions

Patients who have undergone at least one injection to the nerves

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • Patients will be excluded if they:
  • Are not able to understand what is required of them
  • Are not able to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aberdeen Royal Infirmary

Aberdeen, Scotland, AB25 2 ZN, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 36389004BACKGROUND

Related Links

MeSH Terms

Conditions

Abdominal Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, Digestive

Study Officials

  • Saravanakumar Kanakarajan, MD

    NHS Grampian

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2018

First Posted

July 2, 2018

Study Start

September 15, 2017

Primary Completion

September 19, 2018

Study Completion

September 19, 2018

Last Updated

December 24, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations