Lower Back Pain ChronicNCT05801848
Diagnosis of Bone Metabolism in Patients With Inexplicable Lower Back Pain
An observational study of Lower Back Pain Chronic, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The main goal of this study is to determine if static or dynamic [18F]NaF PET/CT (positron emitting tomography) can identify the source of lower backpain in at least 20% of the patients experiencing lower backpain, yet could not be diagnosed from MRI or CT scans. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lower Back Pain Chronic
- What is being tested?
- [18F]NaF PET/CT scan
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- 5 Mar 2023to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with chronic lower back pain where the source could not be identified on MRI scans
Who may be able to join
- Over 18 years
- Chronic lower back pain with no concrete diagnosis after MRI and/or CT
- Under the the care of Rigshospitalets centre for Rheumatology and Spine Disease
Who cannot join
- previous operation in the lower back area
- Known inflammatory related illness or progressive rheumatism
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Rigshospitalet - Centre of Rheumatology and Spine Disease
Glostrup Municipality, 2600
About this study
The main goal of this study is to determine if static or dynamic [18F]NaF PET/CT (positron emitting tomography) can identify the source of lower backpain in at least 20% of the patients experiencing lower backpain, yet could not be diagnosed from MRI or CT scans.
Read the detailed description
Patients with chronic lower backpain are routinely scanned with MR and/or CT to diagnos the source of pain. Larger studies have reported that approximately 20% of patients are given a certain diagnosis from the scans and in the majority of cases the source of the pain is not determined. The use of [18F]NaF PET/CT to map bone perfusion and metabolism is a routine clinical scan that can potentially identify the source of lower backpain in MRI and CT negative patients.
Hypothesis: That [18F]NaF PET/CT bone metabolism and bone perfusion images would contain information that allow the correct diagnosis in at least 20% of patients where MRI and CT images did not reveal pathology.
- Conditions
- Lower Back Pain Chronic
- Being tested
- [18F]NaF PET/CT scan
- Keywords
- NaF PET, Bone metabolism, Bone perfusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]NaF PET/CT scanDiagnostic test
Patients will have their lower back scanned using [18F]NaF PET/CT
| Study group | Role | What they receive |
|---|---|---|
| Chronic lower back pain patients | Patients with chronic lower back pain where the source could not be identified on MRI scans Receives: Diagnostic Test: [18F]NaF PET/CT scan | |
| Age matched healthy controls | Healthy individuals without any previously known pain or intervention on lower back Receives: Diagnostic Test: [18F]NaF PET/CT scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abnormal foci of elevated bone metabolism, blood pooling or bone perfusion
[18F]NaF PET/CT scan
Measured: 1 hour examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2023
- Study start5 Mar 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lower Back Pain ChronicStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Herlev Hospital
- Responsible party
- Principal investigator, Rune Toennesen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Rune Tønnesen, MD PhD, Principal investigator, Rigshospitalet Centre of Rheumatology and Spine Disease
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05801848
- Sponsor's protocol ID
- H-19039428
- Status last verified
- Mar 2023
- First submitted
- 24 Mar 2023
- Last updated
- 6 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gamie S, El-Maghraby T. The role of PET/CT in evaluation of Facet and Disc abnormalities in patients with low back pain using (18)F-Fluoride. Nucl Med Rev Cent East Eur. 2008;11(1):17-21.
PubMed 19173183Kogan F, Broski SM, Yoon D, Gold GE. Applications of PET-MRI in musculoskeletal disease. J Magn Reson Imaging. 2018 Jul;48(1):27-47. doi: 10.1002/jmri.26183.
PubMed 29969193
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosis of Bone Metabolism in Patients With Inexplicable Lower Back Pain
- ClinicalTrials.gov ID
- NCT05801848
- Acronym / sponsor ID
- H-19039428
- Conditions
- Lower Back Pain Chronic
- Keywords
- NaF PET, Bone metabolism, Bone perfusion
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Herlev Hospital
- Study start
- 5 Mar 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 6 Apr 2023 (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.
The main goal of this study is to determine if static or dynamic [18F]NaF PET/CT (positron emitting tomography) can identify the source of lower backpain in at least 20% of the patients experiencing lower backpain, yet could not be diagnosed from MRI or CT scans.
Detailed description
Patients with chronic lower backpain are routinely scanned with MR and/or CT to diagnos the source of pain. Larger studies have reported that approximately 20% of patients are given a certain diagnosis from the scans and in the majority of cases the source of the pain is not determined. The use of [18F]NaF PET/CT to map bone perfusion and metabolism is a routine clinical scan that can potentially identify the source of lower backpain in MRI and CT negative patients.
Hypothesis: That [18F]NaF PET/CT bone metabolism and bone perfusion images would contain information that allow the correct diagnosis in at least 20% of patients where MRI and CT images did not reveal pathology.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic lower back pain patients | – | Diagnostic Test: [18F]NaF PET/CT scanPatients with chronic lower back pain where the source could not be identified on MRI scans |
| Age matched healthy controls | – | Diagnostic Test: [18F]NaF PET/CT scanHealthy individuals without any previously known pain or intervention on lower back |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic lower back pain where the source could not be identified on MRI scans
Key inclusion criteria (3 listed)
- Over 18 years
- Chronic lower back pain with no concrete diagnosis after MRI and/or CT
- Under the the care of Rigshospitalets centre for Rheumatology and Spine Disease
Key exclusion criteria (2 listed)
- previous operation in the lower back area
- Known inflammatory related illness or progressive rheumatism
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 |
|---|---|---|
| [18F]NaF PET/CT scanPatients will have their lower back scanned using [18F]NaF PET/CT | Diagnostic test | Age matched healthy controls, Chronic lower back pain patients |
Primary outcome
Abnormal foci of elevated bone metabolism, blood pooling or bone perfusion
Time frame: 1 hour examination
[18F]NaF PET/CT scan
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2023.
- Results publication: PubMed 19173183Gamie S, El-Maghraby T. The role of PET/CT in evaluation of Facet and Disc abnormalities in patients with low back pain using (18)F-Fluoride. Nucl Med Rev Cent East Eur. 2008;11(1):17-21.
- Results publication: PubMed 29969193Kogan F, Broski SM, Yoon D, Gold GE. Applications of PET-MRI in musculoskeletal disease. J Magn Reson Imaging. 2018 Jul;48(1):27-47. doi: 10.1002/jmri.26183.
- 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.
Rune Tønnesen, MD PhD principal investigator
Rigshospitalet Centre of Rheumatology and Spine Disease
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 Lower Back Pain Chronic, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 3 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 6 Apr 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 Denmark. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Abnormal foci of elevated bone metabolism, blood pooling or bone perfusion (time frame: 1 hour examination). 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 NCT05801848, which also lists 2 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 6 Apr 2023.