Summary:
The proposed study will evaluate the use of a new medication in the treatment of lumbosacral radicular pain. Lumbosacral radicular pain is pain which is usually caused by a pinched nerve in the lower back which causes pain to radiate down the legs. The medication is designed to produce an immediate efect along with a prolonged residency time at the site of the injection due to physical characteristics of the medication.
Study Duration
Subjects will undergo screening approximately 2 weeks before the index injection and will be followed for 6 months after the index injection, therefore overall duration of a subject’s participation in the study is approximately 26 weeks.
Qualified Participants Must:
• Be able and willing to read, write, and understand the English language and provide English language written informed consent prior to beginning any study procedures.
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Be age 18 to 70 years (inclusive) at the Screening Visit.
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Based on medical history (including available medical records), current episode of pain must have been present for at least 6 weeks and not more than 9 months prior to the Screening Visit.
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Patients must not be on chronic use of opiate/narcotic pain medications.
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Patients must not have ever had lumbosacral back surgery or plans to undergo spine surgical intervention while in the study.
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Patients must not have had administered a lumbar epidural or steroid injection for the current episode of pain anytime during the 9 months prior to the Screening Visit.
Qualified Participants May Receive:
Access to the following for no cost:
Medical Imaging
Medical Evaluations
Medical Treatment by University Trained Pain Management Physicians
Additionally, you will be compensated for time and travel.