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Trial record 31 of 337 for:    Charcot Marie Tooth

Abdominal Cutaneous Nerve Entrapment Syndrome (ACNES)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03574727
Recruitment Status : Completed
First Posted : July 2, 2018
Last Update Posted : September 27, 2019
Sponsor:
Collaborator:
NHS Grampian
Information provided by (Responsible Party):
University of Aberdeen

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
Abdominal Pain Abdominal Cutaneous Nerve Entrapment Syndrome Procedure: Injection to or release of anterior cutaneous nerves

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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 : September 15, 2017
Actual Primary Completion Date : September 19, 2018
Actual Study Completion Date : September 19, 2018



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


Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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.

Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03574727


Locations
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United Kingdom
Aberdeen Royal Infirmary
Aberdeen, Scotland, United Kingdom, AB25 2 ZN
Sponsors and Collaborators
University of Aberdeen
NHS Grampian
Investigators
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Principal Investigator: Saravanakumar Kanakarajan, MD NHS Grampian

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Responsible Party: University of Aberdeen
ClinicalTrials.gov Identifier: NCT03574727     History of Changes
Other Study ID Numbers: 2017AN003
First Posted: July 2, 2018    Key Record Dates
Last Update Posted: September 27, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Nerve Compression Syndromes
Charcot-Marie-Tooth Disease
Hereditary Sensory and Motor Neuropathy
Syndrome
Abdominal Pain
Disease
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Signs and Symptoms, Digestive
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Nervous System Malformations
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Polyneuropathies
Congenital Abnormalities
Genetic Diseases, Inborn