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Clinical Trials/NCT06163300
NCT06163300
Recruiting
Not Applicable

MRI Analysis and Degenerative Spine

Universidade Nova de Lisboa1 site in 1 country200 target enrollmentJanuary 1, 2024
ConditionsSpine Disease

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Spine Disease
Sponsor
Universidade Nova de Lisboa
Enrollment
200
Locations
1
Primary Endpoint
ODI - Oswestry Disability Index
Status
Recruiting
Last Updated
2 years ago

Overview

Brief 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
Registry
clinicaltrials.gov
Start Date
January 1, 2024
End Date
September 2026
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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 )

Study Sites (1)

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