Effects and Safety of Epidural PDRN vs. Placebo

Effects and Safety of PDRN (Polydeoxyribonucleotide) for Patient With Lumbar Spinal Stenosis Compared With Normal Saline in Randomized Placebo-Controlled Comparative Pilot Study

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04401735

Enrollment

Registered

2020-05-26

Start date

2019-11-01

Completion date

2020-11-01

Last updated

2020-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Stenosis Lumbar

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.

Interventions

DRUGPolydeoxyribonucleotides

PDRN injection to epidural space

DRUGNormal saline

Normal saline

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

19 Years to 80 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

South Korea

Contacts

Primary ContactLee pyongbok

painfree@snubh.org82-2-787-7495

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026