NCT04876612

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 3, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 6, 2021

Completed
6 months until next milestone

Study Start

First participant enrolled

November 10, 2021

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2025

Completed
Last Updated

May 29, 2024

Status Verified

May 1, 2024

Enrollment Period

3.6 years

First QC Date

May 3, 2021

Last Update Submit

May 27, 2024

Conditions

Lumbar Spinal Stenosis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (15)

  • ODI (Oswestry Disability Index) change

    8 weeks after placebo or limaprost (Opalmon®)

  • ODI (Oswestry Disability Index) change

    12 weeks after placebo or limaprost (Opalmon®)

  • Treadmill test change

    4 weeks after placebo or limaprost (Opalmon®)

  • Treadmill test change

    8 weeks after placebo or limaprost (Opalmon®)

  • Treadmill test change

    12 weeks after placebo or limaprost (Opalmon®)

  • +10 more secondary outcomes

Study Arms (2)

Patients who received placebo after transforminal epidural steroid injection

PLACEBO COMPARATOR

Patients who took placebo for 12 weeks after TFESI

Procedure: Transforaminal epidural steroid injection (TFESI)

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

EXPERIMENTAL

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

Procedure: Transforaminal epidural steroid injection (TFESI)

Interventions

Transforaminal epidural steroid injection (TFESI)PROCEDURE

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.

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

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Spinal Stenosis

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Officials

  • Youn Moon Jee, MD, PhD

    Seoul National University Hospital

    STUDY DIRECTOR

  • Jeongsoo Kim, MD

    SMG-SNU Boramae Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Youn Moon Jee, MD, PhD

CONTACT

821052992036jymoon0901@gmail.com

Jeongsoo Kim, MD

CONTACT

821047346422dreamsu457@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 3, 2021

First Posted

May 6, 2021

Study Start

November 10, 2021

Primary Completion

June 30, 2025

Study Completion

August 31, 2025

Last Updated

May 29, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)