Qutenza 8% Capsaicin Topical System for the Treatment of Neuropathic Axial Lower Back Pain and Lumbosacral Radiculopathy
Launched by MEDICAL UNIVERSITY OF SOUTH CAROLINA · Aug 1, 2024
Trial Information
Current as of June 26, 2025
Enrolling by invitation
Keywords
ClinConnect Summary
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, with a 1-year prevalence of 15-45% and LBP is the most common cause of years lived with disability worldwide. Chronic LBP (defined as LBP lasting less than 3 months) is a complex and heterogeneous condition with nociceptive and neuropathic components.
The goals of treatment of chronic LBP and lumbosacral radiculopathy are to reduce pain, maintain function, and prevent future exacerbation. Gu...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 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 Criteria:
- • 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
About Medical University Of South Carolina
The Medical University of South Carolina (MUSC) is a leading academic health center dedicated to advancing medical research and improving patient care through innovative clinical trials. With a strong emphasis on translational medicine, MUSC leverages its extensive resources and expertise to facilitate groundbreaking studies across various medical disciplines. The institution is committed to fostering collaboration among researchers, healthcare professionals, and patients, ensuring that cutting-edge discoveries translate into effective treatments. As a pioneer in health education and research, MUSC plays a vital role in shaping the future of medicine and enhancing health outcomes in the community and beyond.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Summerville, South Carolina, United States
Patients applied
Trial Officials
Matthew Sherrier
Principal Investigator
Medical University of South Carolina
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported