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

NCT04507113 | Recruiting

• 1 other identifier: RC-P0074
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lumbar Radiculopathy; Magnetic Resonance Imaging; Diffusion Tensor Imaging

Keywords

Lumbar Radiculopathy; Magnetic Resonance Imaging; Diffusion Tensor Imaging; Prognostic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Correlation between DTI parameters and pain intensity

  6 months

• Correlation between DTI parameters evolution and neuropathic pain

  6 months

• Correlation between DTI parameters evolution and disability

  6 months

Study Arms (1)

Lumbar radiculopathy

EXPERIMENTAL

Patients with acute lumbar radiculopathy (less than 3 months of evolution)

Other: DTI sequence acquisition

Interventions

DTI sequence acquisition OTHER

DTI sequence acquisition

Lumbar radiculopathy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lille Catholic University: lead

Study Sites (1)

Groupe Hospitalier de l'Institut Catholique de Lille

Lomme, 59 462, France

RECRUITING

MeSH Terms

Conditions

Radiculopathy

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Jean-François BUDZIK, MD, PhD

  Lille CU

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie Paule LEBITASY, MD, PhD

CONTACT

03.20.22.57.41; Lebitasy.Marie-Paule@ghicl.net

Lucile POISSON, PhD

CONTACT

03.20.22.59.02; poisson.lucile@ghicl.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2020
• First Posted: August 11, 2020
• Study Start: April 6, 2022
• Primary Completion: October 6, 2024
• Study Completion: November 6, 2025
• Last Updated: March 26, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)