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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Magnetic Resonance Imaging; Lumbar Radiculopathy; Diffusion Tensor Imaging
• Intervention / Treatment: Other: DTI sequence acquisition

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marie Paule LEBITASY, MD, PhD; Phone Number: 03.20.22.57.41; Email: Lebitasy.Marie-Paule@ghicl.net
• Study Contact Backup: Name: Lucile POISSON, PhD; Phone Number: 03.20.22.59.02; Email: poisson.lucile@ghicl.net

Study Locations

• France
  • Lomme, France, 59 462
    • Recruiting
    • Groupe Hospitalier de l'Institut Catholique de Lille

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lumbar radiculopathy; Patients with acute lumbar radiculopathy (less than 3 months of evolution)	Other: DTI sequence acquisition; DTI sequence acquisition

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Lille Catholic University
• Investigators: Principal Investigator: Jean-François BUDZIK, MD, PhD, Lille CU

Study record dates

Study Major Dates

• Study Start (Actual): April 6, 2022
• Primary Completion (Estimated): October 6, 2024
• Study Completion (Estimated): November 6, 2025

Study Registration Dates

• First Submitted: August 4, 2020
• First Submitted That Met QC Criteria: August 6, 2020
• First Posted (Actual): August 11, 2020

Study Record Updates

• Last Update Posted (Actual): March 26, 2024
• Last Update Submitted That Met QC Criteria: March 25, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Lumbar Radiculopathy; Magnetic Resonance Imaging; Diffusion Tensor Imaging; Prognostic
• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Radiculopathy
• Other Study ID Numbers: RC-P0074

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No