Summary:
This is a phase three study, primarily to evaluate subjects with lumbosacral radicular pain, while evaluating the safety and efficacy of a single transforaminal injection.
Radicular pain is often secondary to compression or inflammation of a spinal nerve.
When the pain radiates down the back of the leg to the calf or foot, it would in lay terms be described as sciatica.
Qualified Participants Must:
• Have a diagnosis of lumbosacral radicular pain not more than nine months prior to your initial visit with us
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Be between the ages of 18-70 years old
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Must be able to provide recent medical records with diagnosis, X-ray, MRI etc.
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If female must Not Be Pregnant Or Lactating.
Qualified Participants May Receive:
Eligible subjects will be randomly assigned to receive a single dose treatment of a non-opioid Transforaminal epidural injection, or a placebo intramuscular injection under fluoroscopic guidance.
Participants will also receive follow-up and and assessment visits, for a period of 24 weeks after injection.
You will also be reimbursed for your time during the study (at the discretion of the study sponsor).