NCT05080452

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

July 26, 2019

Completed
2.2 years until next milestone

First Posted

Study publicly available on registry

October 15, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

January 12, 2023

Status Verified

January 1, 2023

Enrollment Period

2 years

First QC Date

July 26, 2019

Last Update Submit

January 11, 2023

Conditions

Keywords

ThermographyCT angiographyColor Doppler

Outcome Measures

Primary Outcomes (4)

  • Comparison tender spot coordinates and DIRT coordinates with professional thermocamera

    Distance between coordinates (cm) to evaluate agreement

    One day

  • Comparison tender spot coordinates and CT angiography coordinates

    Distance between coordinates (cm) to evaluate agreement

    One day

  • Comparison tender spot coordinates and color Doppler coordinates

    Distance between coordinates (cm) to evaluate agreement

    One day

  • Comparison hot spot coordinates smarphone/professional thermocamera

    Evaulation if same hot spots are visible on thermal images from both cameras

    One day

Study Arms (2)

ACNES patients

Patients referred to ultrasound-guided treatment for abdominal wall pain caused by ACNES

Diagnostic Test: Dynamic infrared thermography (DIRT)

LUCNES patients

Patients referred to ultrasound-guided treatment for lower back pain caused by LUCNES

Diagnostic Test: Dynamic infrared thermography (DIRT)

Interventions

Visualizing hot spots

Also known as: Comparison to color Doppler ultrasound and CT angiography
ACNES patientsLUCNES patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

25 patients with clinical signs of ACNES 25 patients with clinical signs of LUCNES

You may qualify if:

  • ACNES and LUCNES patients referred for ambulatory ultrasound-guided treatment

You may not qualify if:

  • Former reaction to contrast media used for CT angiography

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of North Norway

Tromsø, 9038, Norway

RECRUITING

Related Publications (8)

  • Lindsetmo RO, Stulberg J. Chronic abdominal wall pain--a diagnostic challenge for the surgeon. Am J Surg. 2009 Jul;198(1):129-34. doi: 10.1016/j.amjsurg.2008.10.027.

    PMID: 19555786BACKGROUND
  • Weum S, de Weerd L. Perforator-Guided Drug Injection in the Treatment of Abdominal Wall Pain. Pain Med. 2016 Jul;17(7):1229-32. doi: 10.1093/pm/pnv011. Epub 2015 Dec 7.

    PMID: 26814247BACKGROUND
  • Weum S, Mercer JB, de Weerd L. Evaluation of dynamic infrared thermography as an alternative to CT angiography for perforator mapping in breast reconstruction: a clinical study. BMC Med Imaging. 2016 Jul 15;16(1):43. doi: 10.1186/s12880-016-0144-x.

    PMID: 27421763BACKGROUND
  • de Weerd L, Weum S, Mercer JB. The value of dynamic infrared thermography (DIRT) in perforatorselection and planning of free DIEP flaps. Ann Plast Surg. 2009 Sep;63(3):274-9. doi: 10.1097/SAP.0b013e3181b597d8.

    PMID: 19700958BACKGROUND
  • de Weerd L, Weum S. The butterfly design: coverage of a large sacral defect with two pedicled lumbar artery perforator flaps. Br J Plast Surg. 2002 Apr;55(3):251-3. doi: 10.1054/bjps.2002.3791.

    PMID: 12041981BACKGROUND
  • de Weerd L, Elvenes OP, Strandenes E, Weum S. Autologous breast reconstruction with a free lumbar artery perforator flap. Br J Plast Surg. 2003 Mar;56(2):180-3. doi: 10.1016/s0007-1226(03)00039-0.

    PMID: 12791371BACKGROUND
  • Weum S, Lott A, de Weerd L. Detection of Perforators Using Smartphone Thermal Imaging. Plast Reconstr Surg. 2016 Nov;138(5):938e-940e. doi: 10.1097/PRS.0000000000002718. No abstract available.

    PMID: 27783018BACKGROUND
  • Cina A, Salgarello M, Barone-Adesi L, Rinaldi P, Bonomo L. Planning breast reconstruction with deep inferior epigastric artery perforating vessels: multidetector CT angiography versus color Doppler US. Radiology. 2010 Jun;255(3):979-87. doi: 10.1148/radiol.10091166. Epub 2010 Apr 14.

    PMID: 20392982BACKGROUND

MeSH Terms

Conditions

Nerve Compression SyndromesAbdominal PainLow Back Pain

Interventions

Computed Tomography Angiography

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, DigestiveBack Pain

Intervention Hierarchy (Ancestors)

Tomography, X-Ray ComputedImage Interpretation, Computer-AssistedDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisMultimodal ImagingRadiographic Image EnhancementImage EnhancementPhotographyRadiographyTomography, X-RayTomography

Study Officials

  • Sven Weum, PhD

    University Hospital of North Norway

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sven Weum, PhD

CONTACT

Louis de Weerd, PhD

CONTACT

Study Design

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

Study Record Dates

First Submitted

July 26, 2019

First Posted

October 15, 2021

Study Start

January 1, 2022

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

January 12, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations