Effect of Limaprost in Combination With Transforaminal Epidural Steroid Injection

  • STATUS
    Recruiting
  • days left to enroll
    13
  • participants needed
    104
  • sponsor
    Seoul National University
Updated on 19 April 2022

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.

Details
Condition Lumbar Spinal Stenosis
Treatment Transforaminal epidural steroid injection (TFESI)
Clinical Study IdentifierNCT04876612
SponsorSeoul National University
Last Modified on19 April 2022

Eligibility

Yes No Not Sure

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
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