Predicting success of epidural injections for sciatica treatment
Prediction of Transforaminal Epidural Injection Success in Sciatica
This study is trying to find out which factors can help predict how well epidural injections will work for people with sciatica caused by a herniated disc or spinal stenosis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 388 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Leiden University Medical Center Academic / other |
| Locations | 1 site (Haarlem) |
| Trial ID | NCT04540068 on ClinicalTrials.gov |
What this trial studies
This observational study aims to develop a predictive model for treatment success following transforaminal epidural injections (TEI) in patients with lumbar radiculopathy due to lumbar disc herniation or spinal stenosis. It will collect demographic, clinical, and radiological data to identify factors that correlate with positive treatment outcomes. Additionally, the study will assess the short-term efficacy of TEI based on pain relief, functionality, and patient-reported recovery scores, as well as the rates of subsequent treatments and surgeries. The findings could help tailor treatment plans for better patient outcomes.
Who should consider this trial
Good fit: Ideal candidates include adults diagnosed with unilateral lumbar radiculopathy due to lumbar disc herniation or one-level spinal stenosis, confirmed by MRI.
Not a fit: Patients with severe multisegmental spinal disease, active malignancy, or those who have had previous treatments for the current episode of lumbar radiculopathy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved patient selection for TEI, enhancing treatment effectiveness for those suffering from sciatica.
How similar studies have performed: While the approach of predicting treatment success based on clinical and radiological parameters is not widely established, similar studies have shown promise in improving treatment outcomes in related conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of unilateral lumbar radiculopathy secondary to LDH or one-level spinal stenosis * Diagnosis supported by magnetic resonance imaging (MRI) findings * Scheduled appointment for TEI * Access to e-mail * Signed informed consent Exclusion Criteria: * Diagnosis of unilateral lumbar radiculopathy secondary to LDH or one-level spinal stenosis * Age under 18 years * Severe multisegmental spinal disease * Anatomical abnormalities that may complicate the procedure technically (e.g. severe scoliosis) * Active malignancy or infectious disease * Use of immunosuppressive drugs * Use of systemic corticosteroids in preceding 3 months * Previous treatment with TEI for current episode of lumbar radiculopathy * History of lower back surgery at the same lumbar level * Circumstances that prevent treatment with TEI (e.g. use of anticoagulants that cannot be temporarily discontinued, allergy against steroids or local anaesthetic) * Pregnancy * Major language barrier
Where this trial is running
Haarlem
- Spaarne Gasthuis — Haarlem, Netherlands (Recruiting)
Study contacts
- Principal investigator: Carmen LA Vleggeert-Lankamp, MD, PhD — Leiden University Medical Centre / Spaarne Gasthuis
- Study coordinator: Eduard JA Verheijen, MD
- Email: e.j.a.verheijen@lumc.nl
- Phone: +3171526746
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.