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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03574727
Other study ID # 2017AN003
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 15, 2017
Est. completion date September 19, 2018

Study information

Verified date September 2019
Source University of Aberdeen
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 35
Est. completion date September 19, 2018
Est. primary completion date September 19, 2018
Accepts healthy volunteers No
Gender All
Age group 16 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Injection to or release of anterior cutaneous nerves
Patients who have undergone at least one injection to the nerves

Locations

Country Name City State
United Kingdom Aberdeen Royal Infirmary Aberdeen Scotland

Sponsors (2)

Lead Sponsor Collaborator
University of Aberdeen NHS Grampian

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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