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Nerve Compression SyndromeNCT05080452

Visualizing ACNES and LUCNES With DIRT

An observational study of Nerve Compression Syndrome and Abdominal Pain, run by University Hospital of North Norway at 1 site in Norway.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Dynamic infrared thermography (DIRT)
How many people
50 participants
Where
1 siteNorway
Study dates
1 Jan 2022to 31 Dec 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: 25 patients with clinical signs of ACNES 25 patients with clinical signs of LUCNES

Who may be able to join

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

Who cannot join

  • Former reaction to contrast media used for CT angiography

Trial locations and contacts

1 site in 1 country.

Sven Weum, PhD contact

(47) 77628311

sven.weum@unn.no

Louis de Weerd, PhD contact

(47) 77669793

louis.deweerd@unn.no

Norway1 site, 1 recruiting
  • University Hospital of North Norway

    Tromsø, 9038

    Sven Weum, MD PhD, +47 77628311, sven.weum@unn.no

    Louis de Weerd, MD PhD, +47 77669793, louis.deweerd@unn.no

    Recruiting

Other trials in Norway

About this study

Official title: Visualizing Anterior Cutaneous Nerve Entrapment Syndrome (ACNES) and Lumbar Cutaneous Nerve Entrapment Syndrome (LUCNES) With Dynamic Infrared Thermography (DIRT)

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.

Read the detailed description

Background

Anterior cutaneous nerve entrapment syndrome (ACNES) is caused by nerve entrapment in the abdominal wall. The entrapment is believed to occur at the exit point of the sensate nerve through the anterior fascia of the rectus abdominis muscle. The diagnosis is mainly based on patient history and clinical examination. Pain relief after local anaesthesia may support the diagnosis. Often patients go through many diagnostic procedures to exclude other possible causes of abdominal pain. In such, ACNES is often an exclusion diagnosis. Recently Weum and de Weerd published an article describing perforator-guided treatment of ACNES using botulinum toxin serotype A (BTA). Based on anatomical knowledge and clinical experience, they used color Doppler ultrasound (CDU) to visualize the vascular structures called perforators that accompany the nerves at the exit points through the anterior rectus fascia. They noticed that accurate placement of the needle at this exit point triggered the same pain as caused by ACNES. Their earlier publications on dynamic infrared thermography (DIRT) in perforator mapping show that the locations of perforators can be visualised as hot spots on the abdominal skin.

Based on their experimental and clinical experience, they found that lower back pain might be caused by nerve entrapment, similar as seen in ACNES. In a pilot study using CDU, they found that the point of maximal pain, as marked by the patient, corresponded with the exit point of a perforator through the lumbar fascia. Knowledge from the use of a lumbar artery perforator flap makes it very likely that the sensate nerve accompanies these perforator vessels. Recently de Weerd and Weum have suggested lumbar cutaneous nerve entrapment syndrome (LUCNES) as a name for this condition. DIRT can potentially be used to identify the locations of these perforators, thereby also indirectly identifying the location of nerve entrapment, when a point of maximal pain corresponds to a hot spot.

Although DIRT has been used in several patients as an adjunct to support the diagnosis of ACNES, there are no studies that have systematically evaluated the use of DIRT in the diagnosis of ACNES or LUCNES. If DIRT could contribute to confirm the diagnosis ACNES or LUCNES, such would be valuable for clinicians as well as patients. Today, ACNES is often a diagnosis made by excluding other causes of pain. If DIRT can be used a reliable technique in the diagnosis of ACNES and LUCNES, such would be of great psychological value to the patients and may contribute to reduced health care costs.

General practitioners are often the first health care providers that see patients with abdominal wall pain and lower back pain. Reliable perforator mapping with DIRT has until recently only been possible with expensive professional thermography equipment. Low-cost thermography cameras for smartphones are now available. If these cameras can provide reliable information on the location of perforators, and thereby also the location of nerve entrapment, general practitioners and other clinicians could use DIRT as a diagnostic tool for this patient group without expensive professional thermography equipment.

Aim and hypotheses

The aim of the study is to evaluate the usefulness of DIRT in the diagnostics of ACNES and LUCNES, as well as evaluating if inexpensive smartphone thermal cameras are equally reliable as professional thermography equipment in the diagnostics of ACNES.

Hypothesis 1: DIRT is a reliable tool to support the diagnosis of ACNES.

Hypothesis 2: DIRT is a reliable tool to support the diagnosis of LUCNES.

Hypothesis 3: Smartphone thermal cameras are equally reliable as professional thermography equipment in the diagnosis of ACNES.

Materials and methods

Patients will be recruited on a voluntary basis from the list of patients referred to the outpatient clinic at the department of plastic surgery, University hospital of North Norway (UNN), with the diagnosis ACNES or LUCNES. Only patients above the age of 18 years, that are not pregnant, with no history of allergic reactions to iodine contrast media, reduced renal function or kidney disease will be included. Based on clinical experience and previous research on perforator mapping, we estimate that 25 patients from each group will provide reliable data to evaluate the usefulness of DIRT.

Patients will be instructed to mark the location of maximal pain on their abdominal wall (ACNES) or lower back (LUCNES) with a permanent marker before arrival at the outpatient clinic. DIRT will be performed simultaneously with professional thermography equipment and a smartphone thermal camera, using the protocol described by Weum and de Weerd. Afterward the point of maximal pain will be marked with a plastic marker taped to the skin, before CTA is performed in the arterial phase. ACNES patients are examined in the supine position, and LUCNES patients in the prone position. The student will perform CDU to evaluate if the point of maximal pain corresponds with a perforator exiting the muscle fascia.

All patients recruited are referred to ultrasound-guided injection with BTA. If CDU reveals that the point of maximal pain corresponds to the exit point of a perforator, the student will perform an ultrasound-guided injection of BTA around the perforator at the exit point. The student will collect data about pain related to needle placement and injection of BTA.

All data will be analyzed with respect to the reliability of DIRT, both with professional equipment and smartphone thermal camera, to identify the location of nerve entrapment. As DIRT only provides indirect information on the point of nerve entrapment, the findings from DIRT will be compared with the findings from both CTA and CDU, which are imaging modalities that are able to visualize these exit points accurately. As an indicator of the usefulness of DIRT, the student will also evaluate the effect of BTA on the pain reported by patients three weeks after the procedure using a VAS score and quality of life assessment compared with data collected before the treatment.

As all patients have been referred for ambulatory treatment at UNN, clinical data will be stored in the electronic patient journal. Findings from the imaging modalities will be stored in the RIS and PACS system at the department of radiology. Following approval by the data protection officer at UNN, depersonalized data will be stored at secure research server and used for later analysis. Data will be stored for seven years after publication and then deleted.

Being tested
Dynamic infrared thermography (DIRT)
Keywords
Thermography, CT angiography, Color Doppler
Medical subject headings
Nerve Compression Syndromes, Abdominal Pain, Low Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dynamic infrared thermography (DIRT)Diagnostic test

    Also called Comparison to color Doppler ultrasound and CT angiography

    Visualizing hot spots

Study groups in NCT05080452
Study groupRoleWhat they receive
ACNES patientsPatients referred to ultrasound-guided treatment for abdominal wall pain caused by ACNES
Receives: Diagnostic Test: Dynamic infrared thermography (DIRT)
LUCNES patientsPatients referred to ultrasound-guided treatment for lower back pain caused by LUCNES
Receives: Diagnostic Test: Dynamic infrared thermography (DIRT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Comparison tender spot coordinates and DIRT coordinates with professional thermocamera

    Distance between coordinates (cm) to evaluate agreement

    Measured: One day

  2. Comparison tender spot coordinates and CT angiography coordinates

    Distance between coordinates (cm) to evaluate agreement

    Measured: One day

  3. Comparison tender spot coordinates and color Doppler coordinates

    Distance between coordinates (cm) to evaluate agreement

    Measured: One day

  4. Comparison hot spot coordinates smarphone/professional thermocamera

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

    Measured: One day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Oct 2021
  2. Study start1 Jan 2022
  3. Primary completion31 Dec 2023 (estimated)
  4. Study completion31 Dec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05080452
Sponsor's protocol ID
Coming
Status last verified
Jan 2023
First submitted
26 Jul 2019
Last updated
12 Jan 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 19555786
  • 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.

    PubMed 26814247
  • 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.

    PubMed 27421763
  • 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.

    PubMed 19700958
  • 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.

    PubMed 12041981
  • 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.

    PubMed 12791371
  • 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.

    PubMed 27783018
  • 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.

    PubMed 20392982

Questions about this trial

What is this clinical trial studying?

An observational study of Nerve Compression Syndrome and Abdominal Pain, run by University Hospital of North Norway at 1 site in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Sven Weum, PhD ((47) 77628311, sven.weum@unn.no), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Comparison tender spot coordinates and DIRT coordinates with professional thermocamera (time frame: One day). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05080452, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2023.

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