Effects and Safety of Epidural PDRN vs. Placebo

Seoul National University

Status and phase: Unknown; Phase 4

Conditions: Spinal Stenosis Lumbar

Treatments: Drug: Normal saline; Drug: Polydeoxyribonucleotides

Study type: Interventional

Funder types: Other

Identifiers

NCT04401735

SNUBHPAIN

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 estimated patients

Sex: All

Ages: 19 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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45 participants in 3 patient groups, including a placebo group

Polydeoxyribonucleotide

Experimental group

Description:

Polydeoxyribonucleotide(PDRN) 5.625mg/3ml

Treatment:

Drug: Polydeoxyribonucleotides

Polydeoxyribonucleotide, Placebo

Experimental group

Description:

Polydeoxyribonucleotide(PDRN) 5.625mg/3ml Placebo (Normal saline)

Treatment:

Drug: Normal saline

Drug: Polydeoxyribonucleotides

Placebo

Placebo Comparator group

Description:

Placebo (Normal saline)

Treatment:

Drug: Normal saline