Effects and Safety of Epidural PDRN vs. Placebo

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Spinal Stenosis Lumbar

Intervention / Treatment
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* Drug: Polydeoxyribonucleotides
* Drug: Normal saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Polydeoxyribonucleotide<br>Polydeoxyribonucleotide(PDRN) 5.625mg/3ml | Drug: Polydeoxyribonucleotides<br>* PDRN injection to epidural space<br>|
| Experimental: Polydeoxyribonucleotide, Placebo<br>Polydeoxyribonucleotide(PDRN) 5.625mg/3ml Placebo (Normal saline) | Drug: Polydeoxyribonucleotides<br>* PDRN injection to epidural space<br>Drug: Normal saline<br>* Normal saline<br>|
| Placebo Comparator: Placebo<br>Placebo (Normal saline) | Drug: Normal saline<br>* Normal saline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| treadmill test | walking distance | 8 weeks post - injection |