Status:
RECRUITING
Effect of Limaprost in Combination With Transforaminal Epidural Steroid Injection
Lead Sponsor:
Seoul National University
Collaborating Sponsors:
SMG-SNU Boramae Medical Center
Conditions:
Lumbar Spinal Stenosis
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
The purpose of this study was to compare the effects of limaprost(Opalmon® ) on walking ability, low back pain and leg pain after transforaminal epidural steroid injection (TFESI) was administered com...
Detailed Description
This study is a prospective, randomized, comparative clinical study that is assigned to a placebo group or a trial group before transforaminal epidural steroid injection (TFESI) is performed. The sub...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2025
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT04876612
Start Date
November 10 2021
End Date
August 31 2025
Last Update
May 29 2024
Active Locations (1)
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1
Seoul National University Hospital
Seoul, South Korea