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Effect of Limaprost in Combination With Transforaminal Epidural Steroid Injection

Primary Purpose

Lumbar Spinal Stenosis

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Transforaminal epidural steroid injection (TFESI)
Sponsored by
Seoul National University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lumbar Spinal Stenosis

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Patients who received placebo after transforminal epidural steroid injection

Patients who received limaprost (Opalmon®) after transforaminal epidural steroid injection

Arm Description

Patients who took placebo for 12 weeks after TFESI

Patients who took limaprost (Opalmon®) for 12 weeks after TFESI

Outcomes

Primary Outcome Measures

ODI (Oswestry Disability Index) change
The change in ODI compared to the baseline was measured at the outpatient visit.

Secondary Outcome Measures

ODI (Oswestry Disability Index) change
The change in ODI compared to the baseline was measured at the outpatient visit.
ODI (Oswestry Disability Index) change
The change in ODI compared to the baseline was measured at the outpatient visit.
Treadmill test change
The change in treadmill test compared to the baseline was measured at the outpatient visit.
Treadmill test change
The change in treadmill test compared to the baseline was measured at the outpatient visit.
Treadmill test change
The change in treadmill test compared to the baseline was measured at the outpatient visit.
Numeric Rating Scale (NRS) change
The change in NRS compared to the baseline was measured at the outpatient visit.
Numeric Rating Scale (NRS) change
The change in NRS compared to the baseline was measured at the outpatient visit.
Numeric Rating Scale (NRS) change
The change in NRS compared to the baseline was measured at the outpatient visit.
Euroqol-5 Dimensions Questionnaire (EQ-5D) change
The change in EQ-5D compared to the baseline was measured at the outpatient visit.
Euroqol-5 Dimensions Questionnaire (EQ-5D) change
The change in EQ-5D compared to the baseline was measured at the outpatient visit.
Euroqol-5 Dimensions Questionnaire (EQ-5D) change
The change in EQ-5D compared to the baseline was measured at the outpatient visit.
Beck Depression Inventory (BPI) change
The change in BPI compared to the baseline was measured at the outpatient visit.
Beck Depression Inventory (BPI) change
The change in BPI compared to the baseline was measured at the outpatient visit.
Beck Depression Inventory (BPI) change
The change in BPI compared to the baseline was measured at the outpatient visit.
Changes in analgesic drugs
The change in analgesic drugs compared to the baseline was measured at the outpatient visit.

Full Information

First Posted
May 3, 2021
Last Updated
September 12, 2022
Sponsor
Seoul National University
Collaborators
SMG-SNU Boramae Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04876612
Brief Title
Effect of Limaprost in Combination With Transforaminal Epidural Steroid Injection
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 10, 2021 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
August 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University
Collaborators
SMG-SNU Boramae Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Spinal Stenosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
104 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients who received placebo after transforminal epidural steroid injection
Arm Type
Placebo Comparator
Arm Description
Patients who took placebo for 12 weeks after TFESI
Arm Title
Patients who received limaprost (Opalmon®) after transforaminal epidural steroid injection
Arm Type
Experimental
Arm Description
Patients who took limaprost (Opalmon®) for 12 weeks after TFESI
Intervention Type
Procedure
Intervention Name(s)
Transforaminal epidural steroid injection (TFESI)
Intervention Description
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.
Primary Outcome Measure Information:
Title
ODI (Oswestry Disability Index) change
Description
The change in ODI compared to the baseline was measured at the outpatient visit.
Time Frame
4 weeks after placebo or limaprost (Opalmon®)
Secondary Outcome Measure Information:
Title
ODI (Oswestry Disability Index) change
Description
The change in ODI compared to the baseline was measured at the outpatient visit.
Time Frame
8 weeks after placebo or limaprost (Opalmon®)
Title
ODI (Oswestry Disability Index) change
Description
The change in ODI compared to the baseline was measured at the outpatient visit.
Time Frame
12 weeks after placebo or limaprost (Opalmon®)
Title
Treadmill test change
Description
The change in treadmill test compared to the baseline was measured at the outpatient visit.
Time Frame
4 weeks after placebo or limaprost (Opalmon®)
Title
Treadmill test change
Description
The change in treadmill test compared to the baseline was measured at the outpatient visit.
Time Frame
8 weeks after placebo or limaprost (Opalmon®)
Title
Treadmill test change
Description
The change in treadmill test compared to the baseline was measured at the outpatient visit.
Time Frame
12 weeks after placebo or limaprost (Opalmon®)
Title
Numeric Rating Scale (NRS) change
Description
The change in NRS compared to the baseline was measured at the outpatient visit.
Time Frame
4 weeks after placebo or limaprost (Opalmon®)
Title
Numeric Rating Scale (NRS) change
Description
The change in NRS compared to the baseline was measured at the outpatient visit.
Time Frame
8 weeks after placebo or limaprost (Opalmon®)
Title
Numeric Rating Scale (NRS) change
Description
The change in NRS compared to the baseline was measured at the outpatient visit.
Time Frame
12 weeks after placebo or limaprost (Opalmon®)
Title
Euroqol-5 Dimensions Questionnaire (EQ-5D) change
Description
The change in EQ-5D compared to the baseline was measured at the outpatient visit.
Time Frame
4 weeks after placebo or limaprost (Opalmon®)
Title
Euroqol-5 Dimensions Questionnaire (EQ-5D) change
Description
The change in EQ-5D compared to the baseline was measured at the outpatient visit.
Time Frame
8 weeks after placebo or limaprost (Opalmon®)
Title
Euroqol-5 Dimensions Questionnaire (EQ-5D) change
Description
The change in EQ-5D compared to the baseline was measured at the outpatient visit.
Time Frame
12 weeks after placebo or limaprost (Opalmon®)
Title
Beck Depression Inventory (BPI) change
Description
The change in BPI compared to the baseline was measured at the outpatient visit.
Time Frame
4 weeks after placebo or limaprost (Opalmon®)
Title
Beck Depression Inventory (BPI) change
Description
The change in BPI compared to the baseline was measured at the outpatient visit.
Time Frame
8 weeks after placebo or limaprost (Opalmon®)
Title
Beck Depression Inventory (BPI) change
Description
The change in BPI compared to the baseline was measured at the outpatient visit.
Time Frame
12 weeks after placebo or limaprost (Opalmon®)
Title
Changes in analgesic drugs
Description
The change in analgesic drugs compared to the baseline was measured at the outpatient visit.
Time Frame
12 weeks after placebo or limaprost (Opalmon®)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Youn Moon Jee, MD, PhD
Phone
821052992036
Email
jymoon0901@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jeongsoo Kim, MD
Phone
821047346422
Email
dreamsu457@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Youn Moon Jee, MD, PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jeongsoo Kim, MD
Organizational Affiliation
SMG-SNU Boramae Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Youn Moon Jee, MD, PhD
Phone
82-10-5299-2036
Email
jymoon0901@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Limaprost in Combination With Transforaminal Epidural Steroid Injection

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