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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04876612
Other study ID # 2102-086-119
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 10, 2021
Est. completion date August 31, 2025

Study information

Verified date May 2024
Source Seoul National University
Contact Youn Moon Jee, MD, PhD
Phone 821052992036
Email jymoon0901@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

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

Study Design


Intervention

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.

Locations

Country Name City State
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (2)

Lead Sponsor Collaborator
Seoul National University SMG-SNU Boramae Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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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