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OpenTrials
Recruiting

NCT Number: NCT06163300

MRI Analysis and Degenerative Spine

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

Recruiting

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Key information

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital da Luz Setúbal

Setúbal, 2900-722, Portugal

Location status: Recruiting

Location contact

Nuno Cristino, MD

CONTACT

[email protected]

+351919484946

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MRI advanced techniques

Diagnostic 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.

Primary outcomes

  1. ODI - Oswestry Disability Index

    Time frame: 18 months

    Measured using the ODI scale (range 0 - 50)

  2. Lumbar Pain Intensity

    Time frame: 18 months

    Measured using the Numeric Pain Rating Scale (range: 0 - 10 )

Study contacts

Contact information is provided by the study sponsor or research team.

Nuno A.R. Cristino, M.D.

CONTACT

[email protected]

+351919484946

Sponsors and collaborators

Lead sponsor

Universidade Nova de Lisboa

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2026
First posted
Dec 8, 2023
Registry last updated
Jan 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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