Using diffusion tensor imaging to assess treatment outcomes in patients with acute lumbar radiculalgia
Prognostic Value Assessment of Biomarkers in Acute Lumbar Radiculalgia : Contribution of the Diffusion Tensor in Magnetic Resonance Imaging
This study is testing if a special type of MRI can help doctors understand how well treatments work for people with sudden back pain caused by nerve issues.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Lille Catholic University Academic / other |
| Locations | 1 site (Lomme) |
| Trial ID | NCT04507113 on ClinicalTrials.gov |
What this trial studies
This study utilizes diffusion tensor imaging (DTI), a non-invasive MRI technique, to evaluate the microstructural changes in nerve roots of patients suffering from acute lumbar radiculalgia. The primary goal is to assess the prognostic value of DTI parameters in predicting therapeutic outcomes over a six-month period. Patients with specific inclusion criteria, such as recent onset of radiculalgia and significant pain levels, will undergo DTI sequence acquisition to gather data. The findings aim to enhance understanding of treatment efficacy for this condition.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have acute lumbar radiculalgia with significant pain levels and meet specific MRI criteria.
Not a fit: Patients with a history of chronic lumbar issues, recent surgeries, or conditions that interfere with pain assessment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into predicting treatment outcomes for patients with lumbar radiculalgia, potentially leading to more personalized and effective therapies.
How similar studies have performed: While DTI is a well-established imaging technique, the specific application for predicting therapeutic outcomes in lumbar radiculalgia is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Lomme
- Groupe Hospitalier de l'Institut Catholique de Lille — Lomme, France (Recruiting)
Study contacts
- Principal investigator: Jean-François BUDZIK, MD, PhD — Lille CU
- Study coordinator: Marie Paule LEBITASY, MD, PhD
- Email: Lebitasy.Marie-Paule@ghicl.net
- Phone: 03.20.22.57.41
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.