Effect of Limaprost in Combination With Transforaminal Epidural Steroid Injection

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

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.

Study Overview

• Status: Recruiting
• Conditions: Lumbar Spinal Stenosis
• Intervention / Treatment: Procedure: Transforaminal epidural steroid injection (TFESI)

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 104
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Seoul National University Hospital
    • Contact: Youn Moon Jee, MD, PhD; Phone Number: 82-10-5299-2036; Email: jymoon0901@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Patients who received placebo after transforminal epidural steroid injection; Patients who took placebo 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.
Experimental: Patients who received limaprost (Opalmon®) after transforaminal epidural steroid injection; 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.

What is the study measuring?

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®)

Collaborators and Investigators

• Sponsor: Seoul National University
• Collaborators: SMG-SNU Boramae Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2021
• Primary Completion (Anticipated): June 30, 2023
• Study Completion (Anticipated): August 31, 2023

Study Registration Dates

• First Submitted: May 3, 2021
• First Submitted That Met QC Criteria: May 3, 2021
• First Posted (Actual): May 6, 2021

Study Record Updates

• Last Update Posted (Actual): September 14, 2022
• Last Update Submitted That Met QC Criteria: September 12, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Constriction, Pathologic; Spinal Stenosis
• Other Study ID Numbers: 2102-086-119

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No