Effects and Safety of Epidural PDRN vs. Placebo

Phase 4

• Conditions: Spinal Stenosis Lumbar
• Interventions: Drug: Polydeoxyribonucleotides; Drug: Normal saline

• Registration Number: NCT04401735
• Lead Sponsor: Seoul National University Hospital

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 contacted every 2 weeks for 4 weeks to determine the severity of pain and degree of pain relief from the injection.

Study Timeline

• Study Start: 2019-11-01
• Status Verified: 2020-05
• Study First Submitted: 2020-05-11
• Study First Submitted QC: 2020-05-22
• Last Update Submitted: 2020-05-22
• Study First Posted: 2020-05-26
• Last Update Posted: 2020-05-26
• Primary Completion: 2020-05-31
• Study Completion: 2020-11-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 45

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Polydeoxyribonucleotide	Polydeoxyribonucleotides	Polydeoxyribonucleotide(PDRN) 5.625mg/3ml
Polydeoxyribonucleotide, Placebo	Polydeoxyribonucleotides	Polydeoxyribonucleotide(PDRN) 5.625mg/3ml Placebo (Normal saline)
Polydeoxyribonucleotide, Placebo	Normal saline	Polydeoxyribonucleotide(PDRN) 5.625mg/3ml Placebo (Normal saline)
Placebo	Normal saline	Placebo (Normal saline)

Primary Outcome Measures

Name	Time	Method
visual analogue scale(VAS)	12 weeks post - injection	This is in pain measurement ranging from 0 when no pain to 10 when there is severe pain(low back pain)

Secondary Outcome Measures

Name	Time	Method
visual analogue scale(VAS)	4, 8 weeks post - injection	This is in pain measurement ranging from 0 when no pain to 10 when there is severe pain(low back pain)
CGI(Clinicians Global Impression)	4, 8 weeks post - injection	7 point scale that requires the clinician to assess how much the patient's illness has improved(grade 0) or worsened(grade 7) relative to a baseline state at the beginning of the intervention.
treadmill test	8 weeks post - injection	walking distance

Trial Locations

Locations (1)

Seoul national university Bundang hospital; 🇰🇷 Seongnam, Kyoung-ki-do, Korea, Republic of