Status:
ENROLLING_BY_INVITATION
Qutenza 8% Capsaicin Topical System for the Treatment of Neuropathic Axial Lower Back Pain and Lumbosacral Radiculopathy
Lead Sponsor:
Medical University of South Carolina
Collaborating Sponsors:
Averitas Pharma, Inc.
Conditions:
Lower Back Pain
Lumbosacral Radiculopathy
Eligibility:
All Genders
18+ years
Brief Summary
This is a research study to find out if Qutenza 8% capsaicin topical system is safe and effective when treating subjects with lower back pain (LBP) that is caused by damage at or near the nerve's root...
Detailed Description
Chronic lower back pain (LBP) and lumbosacral radiculopathy are common, disabling, and costly conditions. The lifetime prevalence of LBP is estimated to be greater than 70% in industrialized countries...
Eligibility Criteria
Inclusion
- Older than 18 years of age
- Willing and have capacity to provide informed consent
- History of symptoms for longer than three months (so as to minimize the chance of spontaneous recovery)
- Pain-DETECT questionnaire (PD-Q) indicating neuropathic component of pain
Exclusion
- Self-reported or medical records showing history of lumbar spine, hip, or lower extremity surgeries within three months
- Chronic opioid use (determined by self-report and review of Prescription Drug Monitoring Program database) - defined as more than 15 morphine milligram equivalents (MME) per day for at least 2 weeks
- Self-reported or medical records showing history of painful peripheral neuropathies (from diabetes mellitus, HIV, or induced by chemotherapy)
- Self-reported allergies to study medications
- Pregnant women (determined by self-report) and prisoners
Key Trial Info
Start Date :
March 13 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 3 2028
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06540456
Start Date
March 13 2025
End Date
July 3 2028
Last Update
March 19 2025
Active Locations (1)
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1
MUSC Health Nexton Medical Park
Summerville, South Carolina, United States, 29483