Lumbar RadiculopathyDiTi-AïeNCT04507113
Diffusion Tensor (DTI) for the Assessement of Therapeutic Evolution of Patients With Acute Lumbar Radiculalgia
A study testing DTI sequence acquisition in people with Lumbar Radiculopathy and Magnetic Resonance Imaging, run by Lille Catholic University at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lumbar Radiculopathy, Magnetic Resonance Imaging, Diffusion Tensor Imaging
- What is being tested?
- DTI sequence acquisition
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 6 Apr 2022to 6 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Groupe Hospitalier de l'Institut Catholique de Lille
Lomme, 59 462
About this study
Official title: 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.
- Being tested
- DTI sequence acquisition
- Keywords
- Lumbar Radiculopathy, Magnetic Resonance Imaging, Diffusion Tensor Imaging, Prognostic
- Medical subject headings
- Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DTI sequence acquisitionOther
DTI sequence acquisition
| Study group | Role | What they receive |
|---|---|---|
| Lumbar radiculopathy | Experimental | Patients with acute lumbar radiculopathy (less than 3 months of evolution) Receives: Other: DTI sequence acquisition |
What is being measured
The primary outcome is the main question the study is designed to answer.
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?
Measured: 6 months
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2020
- Study start6 Apr 2022
- Primary completion6 Oct 2024 (estimated)
- Study completion6 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar RadiculopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lille Catholic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-François BUDZIK, MD, PhD, Principal investigator, Lille CU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04507113
- Sponsor's protocol ID
- RC-P0074
- Acronym
- DiTi-Aïe
- Status last verified
- Mar 2024
- First submitted
- 4 Aug 2020
- Last updated
- 26 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value Assessment of Biomarkers in Acute Lumbar Radiculalgia : Contribution of the Diffusion Tensor in Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT04507113
- Acronym / sponsor ID
- DiTi-Aïe / RC-P0074
- Keywords
- Lumbar Radiculopathy, Magnetic Resonance Imaging, Diffusion Tensor Imaging, Prognostic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Lille Catholic UniversityUniversity, hospital or other
- Study start
- 6 Apr 2022 (actual)
- Primary completion
- 6 Oct 2024 (estimated)
- Study completion
- 6 Nov 2025 (estimated)
- First posted
- 11 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lumbar radiculopathy | Experimental | Other: DTI sequence acquisitionPatients with acute lumbar radiculopathy (less than 3 months of evolution) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DTI sequence acquisitionDTI sequence acquisition | Other | Lumbar radiculopathy |
Primary outcome
Predictive performance of DTI imaging on the therapeutic evolution
Time frame: 6 months
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?
3 secondary outcomes
Correlation between DTI parameters and pain intensity
Time frame: 6 months
Correlation between DTI parameters evolution and neuropathic pain
Time frame: 6 months
Correlation between DTI parameters evolution and disability
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-François BUDZIK, MD, PhD principal investigator
Lille CU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DTI sequence acquisition in people with Lumbar Radiculopathy and Magnetic Resonance Imaging, run by Lille Catholic University at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marie Paule LEBITASY, MD, PhD (03.20.22.57.41, Lebitasy.Marie-Paule@ghicl.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictive performance of DTI imaging on the therapeutic evolution (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2024.