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

Keywords

ClinConnect Summary

This study is checking whether the Qutenza 8% capsaicin patch, placed on the skin, is safe and may help people with neuropathic lower back pain and pain that runs down the leg from nerve problems (lumbosacral radiculopathy). It’s a small, early look (an observational, non-randomized pilot) and will enroll about 50 adults who will be followed for up to 12 months. At visits roughly every few months, clinicians will apply the patch (up to four patches per visit, each visit about 90–120 minutes) and participants will complete surveys about pain and quality of life. Researchers will also watch for any side effects and will track changes in body weight, sleep, overall well-being, and how much other pain medicines or procedures people use.

To be eligible, adults 18 and older must have chronic neuropathic back pain for more than three months and a questionnaire indicating a neuropathic pain component. Exclusions include recent spine surgery, heavy ongoing opioid use, other painful nerve conditions (like diabetic, HIV, or chemotherapy-related neuropathy), patch allergies, pregnancy, or being in prison. The study is being conducted at MUSC Health Nexton Medical Park in Summerville, South Carolina, led by Dr. Matthew Sherrier, with support from a partner company. Results aren’t available yet, but the study will help determine if this patch is a safe and workable option for this specific group of back pain patients.

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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