Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 11:13 PM
Ignite Modification Date:
2025-12-26 @ 11:13 PM
NCT ID:
NCT04876612
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT04876612
Study Brief:
Protocol Section:
NCT04876612