Effects and Safety of Epidural PDRN vs. Placebo

  • STATUS
    Recruiting
  • participants needed
    45
  • sponsor
    Seoul National University Hospital
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Updated on 16 February 2024
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spinal stenosis
stenosis
intermittent claudication
normal saline

Summary

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.

Details
Condition Spinal Stenosis Lumbar
Age 19years - 80years
Treatment Normal saline, Polydeoxyribonucleotides
Clinical Study IdentifierNCT04401735
SponsorSeoul National University Hospital
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

\. Adults aged between 19-80 years old
\. Radiological confirmation of spinal stenosis on MRI
\. Neurogenic claudication greater thanVAS 4 of due to spinal stenosis
\. 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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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