Effects and Safety of Epidural PDRN vs. Placebo

Spinal Stenosis Lumbar Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04401735
• Other study ID #: SNUBHPAIN
• Status: Recruiting
• Phase: Phase 4
• Start date: November 1, 2019
• Est. completion date: November 1, 2020

Study information

• Verified date: May 2020
• Source: Seoul National University Hospital
• Contact: Lee pyongbok
• Phone: 82-2-787-7495
• Email: painfree[@]snubh.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: November 1, 2020
• Est. primary completion date: May 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Constriction, Pathologic
• Spinal Stenosis
• Spinal Stenosis Lumbar

Intervention

Drug:
• Polydeoxyribonucleotides
PDRN injection to epidural space
• Normal saline
Normal saline

Locations

Country	Name	City	State
Korea, Republic of	Seoul national university Bundang hospital	Seongnam	Kyoung-ki-do

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	visual analogue scale(VAS)	This is in pain measurement ranging from 0 when no pain to 10 when there is severe pain(low back pain)	12 weeks post - injection
Secondary	visual analogue scale(VAS)	This is in pain measurement ranging from 0 when no pain to 10 when there is severe pain(low back pain)	4, 8 weeks post - injection
Secondary	CGI(Clinicians Global Impression)	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.	4, 8 weeks post - injection
Secondary	treadmill test	walking distance	8 weeks post - injection