Spine DiseaseNCT06163300
MRI Analysis and Degenerative Spine
An observational study of Spine Disease, run by Universidade Nova de Lisboa at 1 site in Portugal.
Trial summary
Analysis of MRI advanced techniques in degenerative spinal disease. The main questions it aims to answer are: Can we assess microstructural integrity of compressed nerve roots in degenerative spinal disease What are the image biomarkers affected by disease How they evolve with disease progression and treatment Read more about this study
- Who is it for?
- Ages 50 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Spine Disease
- What is being tested?
- MRI advanced techniques
- How many people
- 200 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Jan 2024to Sep 2026
- 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 50 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with suspected diagnosis of the spinal disease in study and that meet the eligibility criteria.
Who may be able to join
- Age between 50 and 85 years
- Diagnosis of spinal disease by clinical and imagiological criteria
- More than 3 months duration of disease
- Ability to give consent
- Fluent portuguese speaker
Who cannot join
- Previous spine surgery
- Spinal instability
- Neurological disease that might interfere with walking
- Known orthopedic conditions that causes significant gait impairment
- Dementia or development disorder with cognitive impairment
- Inability to give consent
Trial locations and contacts
1 site in 1 country.
Portugal1 site, 1 recruiting
- Recruiting
Hospital da Luz Setúbal
Setúbal, 2900-722
Nuno Cristino, MD, +351919484946, nuno.remedio.cristino@hospitaldaluz.pt
About this study
Analysis of MRI advanced techniques in degenerative spinal disease.
The main questions it aims to answer are:
- Can we assess microstructural integrity of compressed nerve roots in degenerative spinal disease
- What are the image biomarkers affected by disease
- How they evolve with disease progression and treatment
- Conditions
- Spine Disease
- Being tested
- MRI advanced techniques
- Medical subject headings
- Spinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI advanced techniquesDiagnostic test
Participants will be submitted to MRI studies at diagnosis, during disease evolution and after treatment. Data collected will be analysed by two different neuroradiologists using advanced techniques.
| Study group | Role | What they receive |
|---|---|---|
| Control | Healthy volunteers Receives: Diagnostic Test: MRI advanced techniques | |
| Disease | Patients affected by disease Receives: Diagnostic Test: MRI advanced techniques |
What is being measured
The primary outcome is the main question the study is designed to answer.
ODI - Oswestry Disability Index
Measured using the ODI scale (range 0 - 50)
Measured: 18 months
Lumbar Pain Intensity
Measured using the Numeric Pain Rating Scale (range: 0 - 10 )
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2023
- Study start1 Jan 2024
- Primary completionSep 2024 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spine DiseaseStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Nova de Lisboa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06163300
- Sponsor's protocol ID
- a319_b
- Status last verified
- Jan 2024
- First submitted
- 30 Nov 2023
- Last updated
- 30 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRI Analysis and Degenerative Spine
- ClinicalTrials.gov ID
- NCT06163300
- Acronym / sponsor ID
- a319_b
- Conditions
- Spine Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Universidade Nova de LisboaUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 8 Dec 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.
Analysis of MRI advanced techniques in degenerative spinal disease.
The main questions it aims to answer are:
- Can we assess microstructural integrity of compressed nerve roots in degenerative spinal disease
- What are the image biomarkers affected by disease
- How they evolve with disease progression and treatment
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | Diagnostic Test: MRI advanced techniquesHealthy volunteers |
| Disease | – | Diagnostic Test: MRI advanced techniquesPatients affected by disease |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with suspected diagnosis of the spinal disease in study and that meet the eligibility criteria.
Key inclusion criteria (5 listed)
- Age between 50 and 85 years
- Diagnosis of spinal disease by clinical and imagiological criteria
- More than 3 months duration of disease
- Ability to give consent
- Fluent portuguese speaker
Key exclusion criteria (6 listed)
- Previous spine surgery
- Spinal instability
- Neurological disease that might interfere with walking
- Known orthopedic conditions that causes significant gait impairment
- Dementia or development disorder with cognitive impairment
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 |
|---|---|---|
| MRI advanced techniquesParticipants will be submitted to MRI studies at diagnosis, during disease evolution and after treatment. Data collected will be analysed by two different neuroradiologists using advanced techniques. | Diagnostic test | Control, Disease |
Primary outcome
ODI - Oswestry Disability Index
Time frame: 18 months
Measured using the ODI scale (range 0 - 50)
Lumbar Pain Intensity
Time frame: 18 months
Measured using the Numeric Pain Rating Scale (range: 0 - 10 )
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
- Individual participant dataSharing planned: Undecided
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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.
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 Spine Disease, run by Universidade Nova de Lisboa at 1 site in Portugal.
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 5 inclusion and 6 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 30 Jan 2024. 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 Portugal. 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 Nuno A.R. Cristino, M.D. (+351919484946, nuno.cristino.ext@nms.unl.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ODI - Oswestry Disability Index (time frame: 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jan 2024.