Actively Recruiting

Phase Not Applicable
Age: 18Years - 85Years
All Genders
NCT04876612

Effect of Limaprost in Combination With Transforaminal Epidural Steroid Injection

Led by Seoul National University · Updated on 2024-05-29

104

Participants Needed

1

Research Sites

198 weeks

Total Duration

On this page

Sponsors

S

Seoul National University

Lead Sponsor

S

SMG-SNU Boramae Medical Center

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Effect of Limaprost in Combination With Transforaminal Epidural Steroid Injection

Who Can Participate

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 18 to 85 years
  • Patients with a new or known diagnosis of lumbar spinal stenosis confirmed by MRI
  • Patients scheduled to undergo transforaminal epidural steroid injection (TFESI) for low back pain or leg pain
Not Eligible

You will not qualify if you...

  • Patients who refuse participation
  • Presence of blood clotting disorders (coagulopathy)
  • Systemic infection or local infection at the injection site
  • Lumbar spine instability
  • Tumors in the needle injection path
  • Allergy to amide-type local anesthetics
  • Cognitive impairment preventing understanding of pain scale (NRS)
  • Peripheral vascular disease including peripheral arterial disease
  • Current use of anticoagulant or antiplatelet drugs
  • Severe cardiovascular, liver, or kidney disease
  • History of cerebral infarction
  • History of gastrointestinal bleeding
  • Recent or expected lumbar spine surgery within 12 months
  • Positive straight leg elevation test
  • Allergy or sensitivity to limaprost (Opalmon�), placebo, or their ingredients

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Seoul National University Hospital

Seoul, South Korea

Actively Recruiting

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Research Team

Y

Youn Moon Jee, MD, PhD

CONTACT

J

Jeongsoo Kim, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Effect of Limaprost in Combination With Transforaminal Epidural Steroid Injection | DecenTrialz