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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
104
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.
Seoul National University Hospital
Seoul, South Korea
RECRUITINGODI (Oswestry Disability Index) change
The change in ODI compared to the baseline was measured at the outpatient visit.
Time frame: 4 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 4 weeks after placebo or limaprost (Opalmon®)
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Numeric Rating Scale (NRS) change
The change in NRS compared to the baseline was measured at the outpatient visit.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 weeks after placebo or limaprost (Opalmon®)