- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06163300
MRI Analysis and Degenerative Spine
January 26, 2024 updated by: Universidade Nova de Lisboa
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 Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Nuno A.R. Cristino, M.D.
- Phone Number: +351919484946
- Email: nuno.cristino.ext@nms.unl.pt
Study Locations
-
-
-
Setúbal, Portugal, 2900-722
- Recruiting
- Hospital da Luz Setúbal
-
Contact:
- Nuno Cristino, MD
- Phone Number: +351919484946
- Email: nuno.remedio.cristino@hospitaldaluz.pt
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Patients with suspected diagnosis of the spinal disease in study and that meet the eligibility criteria.
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Control
Healthy volunteers
|
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.
|
Disease
Patients affected by disease
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ODI - Oswestry Disability Index
Time Frame: 18 months
|
Measured using the ODI scale (range 0 - 50)
|
18 months
|
Lumbar Pain Intensity
Time Frame: 18 months
|
Measured using the Numeric Pain Rating Scale (range: 0 - 10 )
|
18 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2024
Primary Completion (Estimated)
September 1, 2024
Study Completion (Estimated)
September 1, 2026
Study Registration Dates
First Submitted
November 30, 2023
First Submitted That Met QC Criteria
November 30, 2023
First Posted (Actual)
December 8, 2023
Study Record Updates
Last Update Posted (Actual)
January 30, 2024
Last Update Submitted That Met QC Criteria
January 26, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- a319_b
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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