Lumbar Spinal Stenosis Clinical Trial
Official title:
Effect of Limaprost in Combination With Transforaminal Epidural Steroid Injection for the Treatment of Lumbar Spinal Stenosis: a Prospective, Double-blind, Randomized Controlled Trial
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 compared to the placebo group.
Status | Recruiting |
Enrollment | 104 |
Est. completion date | August 31, 2025 |
Est. primary completion date | June 30, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Seoul National University Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Seoul National University | SMG-SNU Boramae Medical Center |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | ODI (Oswestry Disability Index) change | The change in ODI compared to the baseline was measured at the outpatient visit. | 4 weeks after placebo or limaprost (Opalmon®) | |
Secondary | ODI (Oswestry Disability Index) change | The change in ODI compared to the baseline was measured at the outpatient visit. | 8 weeks after placebo or limaprost (Opalmon®) | |
Secondary | ODI (Oswestry Disability Index) change | The change in ODI compared to the baseline was measured at the outpatient visit. | 12 weeks after placebo or limaprost (Opalmon®) | |
Secondary | Treadmill test change | The change in treadmill test compared to the baseline was measured at the outpatient visit. | 4 weeks after placebo or limaprost (Opalmon®) | |
Secondary | Treadmill test change | The change in treadmill test compared to the baseline was measured at the outpatient visit. | 8 weeks after placebo or limaprost (Opalmon®) | |
Secondary | Treadmill test change | The change in treadmill test compared to the baseline was measured at the outpatient visit. | 12 weeks after placebo or limaprost (Opalmon®) | |
Secondary | Numeric Rating Scale (NRS) change | The change in NRS compared to the baseline was measured at the outpatient visit. | 4 weeks after placebo or limaprost (Opalmon®) | |
Secondary | Numeric Rating Scale (NRS) change | The change in NRS compared to the baseline was measured at the outpatient visit. | 8 weeks after placebo or limaprost (Opalmon®) | |
Secondary | Numeric Rating Scale (NRS) change | The change in NRS compared to the baseline was measured at the outpatient visit. | 12 weeks after placebo or limaprost (Opalmon®) | |
Secondary | Euroqol-5 Dimensions Questionnaire (EQ-5D) change | The change in EQ-5D compared to the baseline was measured at the outpatient visit. | 4 weeks after placebo or limaprost (Opalmon®) | |
Secondary | Euroqol-5 Dimensions Questionnaire (EQ-5D) change | The change in EQ-5D compared to the baseline was measured at the outpatient visit. | 8 weeks after placebo or limaprost (Opalmon®) | |
Secondary | Euroqol-5 Dimensions Questionnaire (EQ-5D) change | The change in EQ-5D compared to the baseline was measured at the outpatient visit. | 12 weeks after placebo or limaprost (Opalmon®) | |
Secondary | Beck Depression Inventory (BPI) change | The change in BPI compared to the baseline was measured at the outpatient visit. | 4 weeks after placebo or limaprost (Opalmon®) | |
Secondary | Beck Depression Inventory (BPI) change | The change in BPI compared to the baseline was measured at the outpatient visit. | 8 weeks after placebo or limaprost (Opalmon®) | |
Secondary | Beck Depression Inventory (BPI) change | The change in BPI compared to the baseline was measured at the outpatient visit. | 12 weeks after placebo or limaprost (Opalmon®) | |
Secondary | Changes in analgesic drugs | The change in analgesic drugs compared to the baseline was measured at the outpatient visit. | 12 weeks after placebo or limaprost (Opalmon®) |
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