NCT06540456
Qutenza 8% Capsaicin Topical System for the Treatment of Neuropathic Axial Lower Back Pain and Lumbosacral Radiculopathy
Enrolling by Invitation
Not specifiedAges 18+ObservationalMedical University of South CarolinaInvestigator-initiated
~50 participants
Updated 2026-03-20 on ClinicalTrials.gov
What's tested:Qutenza® 8% Capsaicin Topical System
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of treatment emergent adverse effects as assessed by routine patient monitoring of subjects treated with Qutenza 8% capsaicin topical system for LBP and lumbosacral radiculopathy
Measured over at 12 months
Conditions
Where it's being run
1 sites across 1 statesSouth Carolina1
Study leadership
- Matthew Sherrier · PRINCIPAL_INVESTIGATOR · Medical University of South Carolina
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
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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
What this trial measures
- Incidence of treatment emergent adverse effects as assessed by routine patient monitoring of subjects treated with Qutenza 8% capsaicin topical system for LBP and lumbosacral radiculopathyat 12 months
The primary aim of this pilot study is to assess whether the Qutenza 8% capsaicin topical system is an effective treatment for neuropathic lower back pain and painful lumbosacral radiculopathy as based on PROMIS-29 scores for pain and quality of life. Safety will be determined by the number of participants with treatment-related adverse events as assessed by routine clinical monitoring