Combining Limaprost with Epidural Steroid Injection for Lumbar Spinal Stenosis
Effect of Limaprost in Combination With Transforaminal Epidural Steroid Injection for the Treatment of Lumbar Spinal Stenosis: a Prospective, Double-blind, Randomized Controlled Trial
This study is testing if adding limaprost to an epidural steroid injection can help people with lumbar spinal stenosis walk better and feel less pain.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 104 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Seoul National University Academic / other |
| Locations | 1 site (Seoul) |
| Trial ID | NCT04876612 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of limaprost (Opalmon®) in improving walking ability and reducing pain in patients with lumbar spinal stenosis who are undergoing transforaminal epidural steroid injection (TFESI). Participants are randomly assigned to receive either limaprost or a placebo after the TFESI procedure. The study monitors patients over a 12-week period, with assessments at 4, 8, and 12 weeks to measure outcomes related to pain and mobility. The aim is to determine if limaprost enhances the benefits of TFESI compared to a placebo.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 85 with a diagnosis of lumbar spinal stenosis who are scheduled for TFESI due to low back or leg pain.
Not a fit: Patients with contraindications such as coagulopathy, severe cardiovascular disease, or those who have had recent lumbar spine surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve pain management and mobility for patients suffering from lumbar spinal stenosis.
How similar studies have performed: While the combination of limaprost with TFESI is a novel approach, similar studies have shown positive outcomes with steroid injections for lumbar spinal stenosis.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Patients aged 18 to 85 years Patients with a new or known diagnosis of lumbar spinal stenosis on Magnetic Resonance Imaging (MRI) Patients scheduled to undergo TFESI due to low back pain or leg pain Exclusion Criteria: Refusal of a patient Coagulopathy Systemic infection or local infection at the needle injection site Patients with lumbar instability Neoplasms in the needle path Allergy to amide-type local anesthetics Decreased cognition to the extent that NRS is incomprehensible Patients with peripheral vascular disease (including peripheral arterial disease) Patients taking anticoagulant or antiplatelet drugs Patients with severe cardiovascular disease or liver or kidney disease Patinets with cerebral infarction Patinets with a history of gastrointestinal bleeding Patinets who have had lumbar spine surgery or are expected to receive it within 12 months Patients who show positive in the straight leg elevation test Patients who are allergic or sensitive to limaprost (Opalmon®) and placebo or their ingredients
Where this trial is running
Seoul
- Seoul National University Hospital — Seoul, South Korea (Recruiting)
Study contacts
- Principal investigator: Jeongsoo Kim, MD — SMG-SNU Boramae Medical Center
- Study coordinator: Youn Moon Jee, MD, PhD
- Email: jymoon0901@gmail.com
- Phone: 821052992036
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.