Clinical trial NCT04876612: 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
Overall status: RECRUITING
Phase: NA
Conditions: Lumbar Spinal Stenosis
Lead sponsor: Seoul National University
Sponsor class: OTHER
Collaborators: name: SMG-SNU Boramae Medical Center
First posted: 2021-05-06
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: ODI (Oswestry Disability Index) change
timeFrame: 4 weeks after placebo or limaprost (Opalmon®)
Secondary outcomes:
measure: ODI (Oswestry Disability Index) change
timeFrame: 8 weeks after placebo or limaprost (Opalmon®)
measure: ODI (Oswestry Disability Index) change
timeFrame: 12 weeks after placebo or limaprost (Opalmon®)
measure: Treadmill test change
timeFrame: 4 weeks after placebo or limaprost (Opalmon®)
measure: Treadmill test change
timeFrame: 8 weeks after placebo or limaprost (Opalmon®)
measure: Treadmill test change
timeFrame: 12 weeks after placebo or limaprost (Opalmon®)
measure: Numeric Rating Scale (NRS) change
timeFrame: 4 weeks after placebo or limaprost (Opalmon®)
measure: Numeric Rating Scale (NRS) change
timeFrame: 8 weeks after placebo or limaprost (Opalmon®)
measure: Numeric Rating Scale (NRS) change
timeFrame: 12 weeks after placebo or limaprost (Opalmon®)
measure: Euroqol-5 Dimensions Questionnaire (EQ-5D) change
timeFrame: 4 weeks after placebo or limaprost (Opalmon®)
measure: Euroqol-5 Dimensions Questionnaire (EQ-5D) change
timeFrame: 8 weeks after placebo or limaprost (Opalmon®)
measure: Euroqol-5 Dimensions Questionnaire (EQ-5D) change
timeFrame: 12 weeks after placebo or limaprost (Opalmon®)
measure: Beck Depression Inventory (BPI) change
timeFrame: 4 weeks after placebo or limaprost (Opalmon®)
measure: Beck Depression Inventory (BPI) change
timeFrame: 8 weeks after placebo or limaprost (Opalmon®)
measure: Beck Depression Inventory (BPI) change
timeFrame: 12 weeks after placebo or limaprost (Opalmon®)
measure: Changes in analgesic drugs
timeFrame: 12 weeks after placebo or limaprost (Opalmon®)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Youn Moon Jee, MD, PhD
role: STUDY_DIRECTOR
affiliation: SMG-SNU Boramae Medical Center
name: Jeongsoo Kim, MD
role: PRINCIPAL_INVESTIGATOR
References: