An interventional study of Transforaminal epidural steroid injection (TFESI) in Lumbar Spinal Stenosis, sponsored by Seoul National University. Recruiting at 1 site in Korea, Republic of. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-05-29.
Sponsored by Seoul National University · Not applicable, Interventional, and Treatment
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.
458 studies on the registry are indexed under Spinal Stenosis; 105 are open to participants now.
This study's planned enrollment of 104 is above the median of 80 across 281 interventional studies indexed under Spinal Stenosis.
Browse Spinal Stenosis studies →Seoul National University is the lead sponsor of 32 studies on the registry; 10 are open to participants now.
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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
Patients who took placebo for 12 weeks after TFESI
Procedure: Transforaminal epidural steroid injection (TFESI)
Patients who took limaprost (Opalmon®) for 12 weeks after TFESI
Procedure: Transforaminal epidural steroid injection (TFESI)
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.
ODI (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®)
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®)
Plan to share: No
No publications or documents are linked to this record.
Started Nov 2021 (actual). Primary completion is estimated for Jun 2025, 43 months after the start.
Of 105 non-industry interventional studies with no phase under Spinal Stenosis, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 46. This study's planned 43 months is above that.
Counting every sponsor, half of 123 studies reached it within 30 months; a quarter within 12 and three quarters within 50.
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Seoul National University