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Visualizing ACNES and LUCNES With DIRT

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ClinicalTrials.gov Identifier: NCT05080452
Recruitment Status : Not yet recruiting
First Posted : October 15, 2021
Last Update Posted : October 15, 2021
Sponsor:
Information provided by (Responsible Party):
University Hospital of North Norway

Brief Summary:
Anterior cutaneous nerve entrapment syndrome (ACNES) is caused by nerve entrapment in the abdominal wall. Recently de Weerd and Weum have suggested lumbar cutaneous nerve entrapment syndrome (LUCNES) as a name for a similar condition in the lower back. DIRT can potentially be used to identify the locations of perforators, thereby also indirectly identifying the location of nerve entrapment in ACNES and LUCNES, when a point of maximal pain corresponds to a hot spot. This study evaluates the location of hot spots on DIRT in relation to tender points and perforators visualized with CT angiography and color Doppler. In the ACNES patients, DIRT performed with a low-cost smartphone thermal camera will be compared to DIRT with a professional thermal camera to evaluate the usefulness of low-cost equipment to visualize the point of nerve entrapment.

Condition or disease Intervention/treatment
Nerve Compression Syndrome Abdominal Pain Lower Back Pain Diagnostic Test: Dynamic infrared thermography (DIRT)

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Visualizing Anterior Cutaneous Nerve Entrapment Syndrome (ACNES) and Lumbar Cutaneous Nerve Entrapment Syndrome (LUCNES) With Dynamic Infrared Thermography (DIRT)
Estimated Study Start Date : November 1, 2021
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022


Group/Cohort Intervention/treatment
ACNES patients
Patients referred to ultrasound-guided treatment for abdominal wall pain caused by ACNES
Diagnostic Test: Dynamic infrared thermography (DIRT)
Visualizing hot spots
Other Name: Comparison to color Doppler ultrasound and CT angiography

LUCNES patients
Patients referred to ultrasound-guided treatment for lower back pain caused by LUCNES
Diagnostic Test: Dynamic infrared thermography (DIRT)
Visualizing hot spots
Other Name: Comparison to color Doppler ultrasound and CT angiography




Primary Outcome Measures :
  1. Comparison tender spot coordinates and DIRT coordinates with professional thermocamera [ Time Frame: One day ]
    Distance between coordinates (cm) to evaluate agreement

  2. Comparison tender spot coordinates and CT angiography coordinates [ Time Frame: One day ]
    Distance between coordinates (cm) to evaluate agreement

  3. Comparison tender spot coordinates and color Doppler coordinates [ Time Frame: One day ]
    Distance between coordinates (cm) to evaluate agreement

  4. Comparison hot spot coordinates smarphone/professional thermocamera [ Time Frame: One day ]
    Evaulation if same hot spots are visible on thermal images from both cameras



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
25 patients with clinical signs of ACNES 25 patients with clinical signs of LUCNES
Criteria

Inclusion Criteria:

ACNES and LUCNES patients referred for ambulatory ultrasound-guided treatment

Exclusion Criteria:

Former reaction to contrast media used for CT angiography


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): NCT05080452


Contacts
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Contact: Sven Weum, PhD (47) 77628311 sven.weum@unn.no
Contact: Louis de Weerd, PhD (47) 77669793 louis.deweerd@unn.no

Sponsors and Collaborators
University Hospital of North Norway
Investigators
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Principal Investigator: Sven Weum, PhD University Hospital of North Norway
Publications:

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Responsible Party: University Hospital of North Norway
ClinicalTrials.gov Identifier: NCT05080452    
Other Study ID Numbers: Coming
First Posted: October 15, 2021    Key Record Dates
Last Update Posted: October 15, 2021
Last Verified: September 2021
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
Keywords provided by University Hospital of North Norway:
Thermography
CT angiography
Color Doppler
Additional relevant MeSH terms:
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Nerve Compression Syndromes
Charcot-Marie-Tooth Disease
Hereditary Sensory and Motor Neuropathy
Syndrome
Abdominal Pain
Low Back Pain
Disease
Pathologic Processes
Back Pain
Pain
Neurologic Manifestations
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