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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
45
PDRN injection to epidural space
Normal saline
Seoul national university Bundang hospital
Seongnam, Kyoung-ki-do, South Korea
RECRUITINGvisual analogue scale(VAS)
This is in pain measurement ranging from 0 when no pain to 10 when there is severe pain(low back pain)
Time frame: 12 weeks post - injection
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)
Time frame: 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.
Time frame: 4, 8 weeks post - injection
treadmill test
walking distance
Time frame: 8 weeks post - injection
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