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Effects and Safety of Epidural PDRN vs. Placebo

Effects and Safety of Epidural PDRN vs. Placebo

Recruiting
19-80 years
All
Phase 4

Overview

This is a single-center, randomized, double-blind clinical study to assess the clinical application and outcomes with epidural PDRN versus Normal saline injection in patients with spinal stenosis.

Description

Patients who are already planning to receive an Transforaminal epidural block from their clinician will be approached by study members on the day of their injection. If enrolled, the patients will be contacted every 2 weeks for 4 weeks to determine the severity of pain and degree of pain relief from the injection.

Eligibility

Inclusion Criteria:

  • 1. Adults aged between 19-80 years old
  • 2. Radiological confirmation of spinal stenosis on MRI
  • 3. Neurogenic claudication greater thanVAS 4 of due to spinal stenosis
  • 4. Follow-up possible during 3 months the clinical trial

Exclusion Criteria:

  • Not able to comply fully with the protocol, including treatment, follow-up or study procedures
  • pregnant or feeding women
  • Alcohol/drug abuse
  • Anticoagulant medication

Study details
    Spinal Stenosis Lumbar

NCT04401735

Seoul National University Hospital

16 February 2024

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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