NCT06163300

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
3mo left

Started Jan 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress88%
Jan 2024Sep 2026

First Submitted

Initial submission to the registry

November 30, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 8, 2023

Completed
24 days until next milestone

Study Start

First participant enrolled

January 1, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Expected
Last Updated

January 30, 2024

Status Verified

January 1, 2024

Enrollment Period

8 months

First QC Date

November 30, 2023

Last Update Submit

January 26, 2024

Conditions

Spine Disease

Outcome Measures

Primary Outcomes (2)

  • ODI - Oswestry Disability Index

    Measured using the ODI scale (range 0 - 50)

    18 months

  • Lumbar Pain Intensity

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

    18 months

Study Arms (2)

Control

Healthy volunteers

Diagnostic Test: MRI advanced techniques

Disease

Patients affected by disease

Diagnostic Test: MRI advanced techniques

Interventions

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.

ControlDisease

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with suspected diagnosis of the spinal disease in study and that meet the eligibility criteria.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital da Luz Setúbal

Setúbal, 2900-722, Portugal

RECRUITING

MeSH Terms

Conditions

Spinal Diseases

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal Diseases

Central Study Contacts

Nuno A.R. Cristino, M.D.

CONTACT

+351919484946nuno.cristino.ext@nms.unl.pt

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2023

First Posted

December 8, 2023

Study Start

January 1, 2024

Primary Completion

September 1, 2024

Study Completion (Estimated)

September 1, 2026

Last Updated

January 30, 2024

Record last verified: 2024-01

Locations

PT(1)