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NCT06163300 Clinical Trial

MRI Analysis and Degenerative Spine

Spine Disease Clinical Trial

Official title:
MRI Analysis and Degenerative Spine

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06163300
Other study ID # a319_b
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2024
Est. completion date September 2026

Study information
Verified date January 2024
Source Universidade Nova de Lisboa
Contact Nuno A.R. Cristino, M.D.
Phone +351919484946
Email nuno.cristino.ext@nms.unl.pt
Is FDA regulated No
Health authority
Study type Observational

Clinical 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

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date September 2026
Est. primary completion date September 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 50 Years to 85 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• MRI advanced techniques
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.

Locations
Country Name City State
Portugal Hospital da Luz Setúbal Setúbal

Sponsors (1)
Lead Sponsor Collaborator
Universidade Nova de Lisboa

Country where clinical trial is conducted

Portugal, 

Outcome
Type Measure Description Time frame Safety issue
Primary ODI - Oswestry Disability Index Measured using the ODI scale (range 0 - 50) 18 months
Primary Lumbar Pain Intensity Measured using the Numeric Pain Rating Scale (range: 0 - 10 ) 18 months
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