Qutenza 8% Capsaicin Topical System for the Treatment of Neuropathic Axial Lower Back Pain and Lumbosacral Radiculopathy

Conditions: Lower Back Pain
Lumbosacral Radiculopathy

Registration Number: NCT06540456

Lead Sponsor: Medical University of South Carolina

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Enrolling by invitation

Sex: All

Target Recruitment: 50

Inclusion 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

Exclusion Criteria

Not provided

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Assess changes in body mass index (BMI) in patients receiving the Qutenza 8% capsaicin topical system.;Assess changes in quality of life and sleep in patients receiving the Qutenza 8% capsaicin topical system.;Assess changes in medication and procedural utilization in patients receiving the Qutenza 8% capsaicin topical system.