Status:
UNKNOWN
Effects and Safety of Epidural PDRN vs. Placebo
Lead Sponsor:
Seoul National University Hospital
Conditions:
Spinal Stenosis Lumbar
Eligibility:
All Genders
19-80 years
Phase:
PHASE4
Brief 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.
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
- Not able to comply fully with the protocol, including treatment, follow-up or study procedures
- pregnant or feeding women
- Alcohol/drug abuse
- Anticoagulant medication
Key Trial Info
Start Date :
November 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2020
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT04401735
Start Date
November 1 2019
End Date
November 1 2020
Last Update
May 26 2020
Active Locations (1)
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1
Seoul national university Bundang hospital
Seongnam, Kyoung-ki-do, South Korea, 463-707