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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Polydeoxyribonucleotide | Experimental | Polydeoxyribonucleotide(PDRN) 5.625mg/3ml |
|
| Polydeoxyribonucleotide, Placebo | Experimental | Polydeoxyribonucleotide(PDRN) 5.625mg/3ml Placebo (Normal saline) |
|
| Placebo | Placebo Comparator | Placebo (Normal saline) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Polydeoxyribonucleotides | Drug | PDRN injection to epidural space |
|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lee pyongbok | Contact | 82-2-787-7495 | painfree@snubh.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul national university Bundang hospital | Recruiting | Seongnam | Kyoung-ki-do | 463-707 | South Korea |
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| ID | Term |
|---|---|
| D011089 | Polydeoxyribonucleotides |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D011119 | Polynucleotides |
| D009711 | Nucleotides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D000077324 | Crystalloid Solutions |
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| Normal saline | Drug | Normal saline |
|
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 |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |