Diffusion Tensor (DTI) for the Assessement of Therapeutic Evolution of Patients With Acute Lumbar Radiculalgia

Magnetic Resonance Imaging Clinical Trial

— DiTi-Aïe  

Official title:

Prognostic Value Assessment of Biomarkers in Acute Lumbar Radiculalgia : Contribution of the Diffusion Tensor in Magnetic Resonance Imaging

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04507113
• Other study ID #: RC-P0074
• Status: Recruiting
• Phase: N/A
• Start date: April 6, 2022
• Est. completion date: November 6, 2025

Study information

• Verified date: March 2024
• Source: Lille Catholic University
• Contact: Marie Paule LEBITASY, MD, PhD
• Phone: 03.20.22.57.41
• Email: Lebitasy.Marie-Paule[@]ghicl.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Diffusion tensor imaging (DTI) is a non-invasive MRI technique offering a functional approach that provides morphological information about the microstructures of the nerve roots. DTI is a widely used neuroimaging technique and is a current topic of research in the field of peripheral nerve imaging.The aim of the study is to determine the prognostic quality of the DTI parameters to predict the therapeutic evolution of patients with lumbar radiculalgia at 6 months.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: November 6, 2025
• Est. primary completion date: October 6, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18 ans

• Patient with Lumbar Radiculalgia (L4, L5 or S1)

• Pain VAS (Visual analog scale) > 30/100

• Less than 3 months of evolution

• With a radiculalgia superior or equal to lumbalgia

• Disco radicular conflict, verified by MRI

• Able to receive information

• Affiliated to French social security

Exclusion Criteria:

• History of chronic lumbalgia and radiculalgia

• History of lumbar surgery

• Recent episode (less than 6 months) with the same radicular topography

• Bilateral radicular compression on MRI

• Patient requiring emergency surgery

• Evolutive disease interfering with pain assesment (neoplasia, inflammatory rheumatism, peripheral neuropathy, central neurological disease)

• MRI contraindication

Related Conditions & MeSH terms

• Diffusion Tensor Imaging
• Lumbar Radiculopathy
• Magnetic Resonance Imaging
• Radiculopathy

Intervention

Other:
• DTI sequence acquisition
DTI sequence acquisition

Locations

Country	Name	City	State
France	Groupe Hospitalier de l'Institut Catholique de Lille	Lomme

Sponsors (1)

Lead Sponsor	Collaborator
Lille Catholic University

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Predictive performance of DTI imaging on the therapeutic evolution	DTI is a sensitive probe of cellular structure that works by measuring the diffusion of water molecules. The measured quantity is the diffusion coefficient, a proportionality constant that relates diffusive flux to a concentration gradient and has units of mm2/s.; The objective is to know if the interpretation of DTI allow to predict the therapeutic evolution of patients. For instance, the patients will need in the future oral drugs? Or they will need rather an infiltration? Or they will need rather a surgery?	6 months
Secondary	Correlation between DTI parameters and pain intensity	DTI is a sensitive probe of cellular structure that works by measuring the diffusion of water molecules. The measured quantity is the diffusion coefficient, a proportionality constant that relates diffusive flux to a concentration gradient and has units of mm2/s.; The intensity of pain will be self evaluated by the visual analogue scale (VAS). This scale is between 0 and 10 (in cms) being absence of pain and 10 intolerable pain.	6 months
Secondary	Correlation between DTI parameters evolution and neuropathic pain	DTI is a sensitive probe of cellular structure that works by measuring the diffusion of water molecules. The measured quantity is the diffusion coefficient, a proportionality constant that relates diffusive flux to a concentration gradient and has units of mm2/s.; The presence of neuropathic pain will be evaluated by the Neuropathic Pain Symptom Inventory (NPSI) scale. This is a self-questionnaire.The tool evaluates mean pain intensity in the last 24h in a verbal numeric scale from zero (no pain) to 10 (worst imaginable pain). Total pain intensity score may be calculated by the sum of 10 descriptors.	6 months
Secondary	Correlation between DTI parameters evolution and disability	DTI is a sensitive probe of cellular structure that works by measuring the diffusion of water molecules. The measured quantity is a diffusion coefficient, a proportionality constant that relates diffusive flux to a concentration gradient and has units of mm2/s. The disability will be measured by the Oswestry Disability Index (ODI). The final score/index ranges from 0-100. A score of 0-20 reflects minimal disability, 21-40 moderate disability, 41-60 severe disability, 61-80 crippled, and 81-100 bed-bound.	6 months