Back to resultsDiffusion Tensor (DTI) for the Assessement of Therapeutic Evolution of Patients With Acute Lumbar Radiculalgia (DiTi-Aïe)
Primary Purpose
Lumbar Radiculopathy, Magnetic Resonance Imaging, Diffusion Tensor Imaging
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
DTI sequence acquisition
Sponsored by
About this trial
This is an interventional diagnostic trial for Lumbar Radiculopathy focused on measuring Lumbar Radiculopathy, Magnetic Resonance Imaging, Diffusion Tensor Imaging, Prognostic
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Lumbar radiculopathy
Arm Description
Patients with acute lumbar radiculopathy (less than 3 months of evolution)
Outcomes
Primary Outcome Measures
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?
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT04507113
First Posted
August 4, 2020
Last Updated
August 6, 2020
Sponsor
Lille Catholic University
1. Study Identification
Unique Protocol Identification Number
NCT04507113
Brief Title
Diffusion Tensor (DTI) for the Assessement of Therapeutic Evolution of Patients With Acute Lumbar Radiculalgia
Acronym
DiTi-Aïe
Official Title
Prognostic Value Assessment of Biomarkers in Acute Lumbar Radiculalgia : Contribution of the Diffusion Tensor in Magnetic Resonance Imaging
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2021 (Anticipated)
Primary Completion Date
July 1, 2021 (Anticipated)
Study Completion Date
July 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lille Catholic University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Radiculopathy, Magnetic Resonance Imaging, Diffusion Tensor Imaging
Keywords
Lumbar Radiculopathy, Magnetic Resonance Imaging, Diffusion Tensor Imaging, Prognostic
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Lumbar radiculopathy
Arm Type
Experimental
Arm Description
Patients with acute lumbar radiculopathy (less than 3 months of evolution)
Intervention Type
Other
Intervention Name(s)
DTI sequence acquisition
Intervention Description
DTI sequence acquisition
Primary Outcome Measure Information:
Title
Predictive performance of DTI imaging on the therapeutic evolution
Description
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?
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Correlation between DTI parameters and pain intensity
Description
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.
Time Frame
6 months
Title
Correlation between DTI parameters evolution and neuropathic pain
Description
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.
Time Frame
6 months
Title
Correlation between DTI parameters evolution and disability
Description
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.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amélie LANSIAUX, MD, PhD
Phone
03.20.22.52.69
Email
lansiaux.amelie@ghicl.net
First Name & Middle Initial & Last Name or Official Title & Degree
Amel BOULAFA, Master
Phone
03.20.22.52.69
Email
boulafa.amel@ghicl.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-François BUDZIK, MD, PhD
Organizational Affiliation
Lille CU
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Diffusion Tensor (DTI) for the Assessement of Therapeutic Evolution of Patients With Acute Lumbar Radiculalgia
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