Effect of Limaprost in Combination With Transforaminal Epidural Steroid Injection

Study Overview
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Brief Summary
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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.

Detailed Description
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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 subjects of the study will receive an explanation of the study and decide to participate voluntarily in patients who have decided to undergo TFESI for neurogenic claudication and low back pain or leg pain due to lumbar spinal canal stenosis (LSS). All study subjects are presented with TFESI at the level appropriate for their symptoms in the operating room and then returned to the recovery room. All participants will be monitored for non-invasive blood pressure, electrocardiography, heart rate, and peripheral oxyven saturation during and after the procedure. Patients assigned to the placebo group will take placebo three times a day and one tablet once from the first day after receiving TFESI. Patients assigned to the trial group will take limaprost (Opalmon®) three times a day, one tablet once from the first day after receiving TFESI. In both groups, the drug was administered for 12 weeks. In both groups, during the first 4 weeks, no drug changes or additional procedures were observed, and only Acetaminophen was allowed as a rescue drug. After TFESI, visits at 4 weeks, 8 weeks and 12 weeks to collect each measurement variable.

Official Title
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Effect of Limaprost in Combination With Transforaminal Epidural Steroid Injection for the Treatment of Lumbar Spinal Stenosis: a Prospective, Double-blind, Randomized Controlled Trial

Conditions
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Lumbar Spinal Stenosis

Intervention / Treatment
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* Procedure: Transforaminal epidural steroid injection (TFESI)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Patients who received placebo after transforminal epidural steroid injection<br>Patients who took placebo for 12 weeks after TFESI | Procedure: Transforaminal epidural steroid injection (TFESI)<br>* Well trained pain physician performs all the fluoroscopy-guided transforaminal epidural steroid injection (TFESI), who is not involved in evaluating study variables. Electrocardiography, noninvasive blood pressure, heart rate, and peripheral oxygen saturation were monitored for all patients before, while, and after conducting procedure. For TFESI, patients are prone positioned, and skin preparation on injection site is done with chlorohexidine. Procedure is conducted under fluoroscopy guidance at the patient's symptom complaining level. After confirming with a contrast medium, 3 ml of 0.1875% ropivacaine and 5 mg of dexamethasone are administered.<br>|
| Experimental: Patients who received limaprost (Opalmon®) after transforaminal epidural steroid injection<br>Patients who took limaprost (Opalmon®) for 12 weeks after TFESI | Procedure: Transforaminal epidural steroid injection (TFESI)<br>* Well trained pain physician performs all the fluoroscopy-guided transforaminal epidural steroid injection (TFESI), who is not involved in evaluating study variables. Electrocardiography, noninvasive blood pressure, heart rate, and peripheral oxygen saturation were monitored for all patients before, while, and after conducting procedure. For TFESI, patients are prone positioned, and skin preparation on injection site is done with chlorohexidine. Procedure is conducted under fluoroscopy guidance at the patient's symptom complaining level. After confirming with a contrast medium, 3 ml of 0.1875% ropivacaine and 5 mg of dexamethasone are administered.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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®) | 
| 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®) | 
| 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®) | 
| 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®) | 
| 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®) | 
| 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®) | 
| 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®) | 
| 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®) | 
| 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®) | 
| 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®) | 
| 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®) | 
| 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®) | 
| 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®) | 
| 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®) | 
| 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®) |