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.
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
- Conditions the study is for
- Nerve Compression Syndrome, Abdominal Pain, Lower Back Pain
- 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.
Norway1 site, 1 recruiting
- 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
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.
- Conditions
- Nerve Compression Syndrome, Abdominal Pain, Lower Back Pain
- 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 group | Role | What they receive |
|---|---|---|
| ACNES patients | Patients referred to ultrasound-guided treatment for abdominal wall pain caused by ACNES Receives: Diagnostic Test: Dynamic infrared thermography (DIRT) | |
| LUCNES patients | Patients 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.
Comparison tender spot coordinates and DIRT coordinates with professional thermocamera
Distance between coordinates (cm) to evaluate agreement
Measured: One day
Comparison tender spot coordinates and CT angiography coordinates
Distance between coordinates (cm) to evaluate agreement
Measured: One day
Comparison tender spot coordinates and color Doppler coordinates
Distance between coordinates (cm) to evaluate agreement
Measured: One day
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.
- First posted15 Oct 2021
- Study start1 Jan 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Nerve Compression SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University Hospital of North Norway
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sven Weum, PhD, Principal investigator, University Hospital of North Norway
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 19555786Weum 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 26814247Weum 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 27421763de 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 19700958de 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 12041981de 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 12791371Weum 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 27783018Cina 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
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visualizing Anterior Cutaneous Nerve Entrapment Syndrome (ACNES) and Lumbar Cutaneous Nerve Entrapment Syndrome (LUCNES) With Dynamic Infrared Thermography (DIRT)
- ClinicalTrials.gov ID
- NCT05080452
- Acronym / sponsor ID
- Coming
- Conditions
- Nerve Compression Syndrome, Abdominal Pain, Lower Back Pain
- Keywords
- Thermography, CT angiography, Color Doppler
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital of North NorwayUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 15 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACNES patients | – | Diagnostic Test: Dynamic infrared thermography (DIRT)Patients referred to ultrasound-guided treatment for abdominal wall pain caused by ACNES |
| LUCNES patients | – | Diagnostic Test: Dynamic infrared thermography (DIRT)Patients referred to ultrasound-guided treatment for lower back pain caused by LUCNES |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 25 patients with clinical signs of ACNES 25 patients with clinical signs of LUCNES
Key inclusion criteria (1 listed)
- ACNES and LUCNES patients referred for ambulatory ultrasound-guided treatment
Key exclusion criteria (1 listed)
- Former reaction to contrast media used for CT angiography
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dynamic infrared thermography (DIRT)Also: Comparison to color Doppler ultrasound and CT angiographyVisualizing hot spots | Diagnostic test | ACNES patients, LUCNES patients |
Primary outcome
Comparison tender spot coordinates and DIRT coordinates with professional thermocamera
Time frame: One day
Distance between coordinates (cm) to evaluate agreement
Comparison tender spot coordinates and CT angiography coordinates
Time frame: One day
Distance between coordinates (cm) to evaluate agreement
Comparison tender spot coordinates and color Doppler coordinates
Time frame: One day
Distance between coordinates (cm) to evaluate agreement
Comparison hot spot coordinates smarphone/professional thermocamera
Time frame: One day
Evaulation if same hot spots are visible on thermal images from both cameras
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2023.
- Background: PubMed 19555786Lindsetmo 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.
- Background: PubMed 26814247Weum 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.
- Background: PubMed 27421763Weum 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.
- Background: PubMed 19700958de 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.
- Background: PubMed 12041981de 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.
- Background: PubMed 12791371de 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.
- Background: PubMed 27783018Weum 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.
- Background: PubMed 20392982Cina 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sven Weum, PhD principal investigator
University Hospital of North Norway
1 site in 1 country: see every site and its status.
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.