Effect of Limaprost in Combination With Transforaminal Epidural Steroid Injection

Lumbar Spinal Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04876612
• Other study ID #: 2102-086-119
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Constriction, Pathologic
• Lumbar Spinal Stenosis
• Spinal Stenosis

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®)