Precision treatment for lumbar spine issues using nerve root blocks
Precision Treatment of Lumbar Spine Surgery Through Advanced Nerve Root Blockade
This study is testing if a specific injection for back pain can help doctors decide if surgery is needed for patients with nerve issues caused by a herniated disc.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Aarhus Academic / other |
| Locations | 1 site (Aarhus C) |
| Trial ID | NCT06143813 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of selective spinal nerve root blocks (SNRB) in improving the diagnosis of radiculopathy caused by lumbar disc herniation and other spinal conditions. It is designed as a prospective randomized controlled trial where patients with suspected radiculopathy will be randomly assigned to receive either standard care or SNRB before surgical decision-making. The outcomes of the SNRB will inform the surgeon's decision on whether to proceed with surgery. Follow-up assessments will be conducted at 1, 3, and 12 months post-surgery to evaluate patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with suspected lumbar radiculopathy lasting more than 8 weeks and radiological evidence of nerve root compression.
Not a fit: Patients who have previously undergone lumbar spine surgery or have severe physical co-morbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more accurate surgical decisions and improved outcomes for patients with lumbar spine conditions.
How similar studies have performed: Other studies have shown promise in using nerve root blocks for diagnostic purposes, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \>18 years old * Suspected lumbar radiculopathy persistent ≥ 8 weeks * Radiological evidence of lumbar nerve root compression (herniated disc, recess stenosis, foraminal stenosis) Exclusion Criteria: * Prior lumbar spine surgery * Mental illness * Language barrier in Danish * Severe physical co-morbidity * Known allergies to medicine used in the study * Pregnant * Plans to move abroad during the next 12-months
Where this trial is running
Aarhus C
- Aarhus University Hospital — Aarhus C, Denmark (Recruiting)
Study contacts
- Principal investigator: David Kocemba, MD — University of Aarhus
- Study coordinator: David Kocemba, MD
- Email: davkoc@rm.dk
- Phone: +45 23882198
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.