Qutenza 8% Capsaicin Topical System for the Treatment of Neuropathic Axial Lower Back Pain and Lumbosacral Radiculopathy
NCT Number: NCT06540456
Status: ENROLLING_BY_INVITATION
Study Type: OBSERVATIONAL
Conditions: Lower Back Pain|Lumbosacral Radiculopathy
Interventions: DRUG: Qutenza® 8% Capsaicin Topical System
Sponsor: Medical University of South Carolina
Collaborators: Averitas Pharma, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-10-12
Completion Date: 2028-07-03
Locations: MUSC Health Nexton Medical Park, Summerville, South Carolina, 29483, United States

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 in the lower back leg (lumbosacral radiculopathy) which is pain that can move all the way down the back of the leg. The pain may also start outside of the spinal cord, in the peripheral nerves and may also be felt all the way down the back of the leg (neuropathic LBP). Qutenza 8% capsaicin, the study drug, is currently FDA approved to treat nerve pain after a shingles outbreak in addition to a type of nerve pain in the feet associated with diabetes. In this study a maximum of four patches per visit (sized 14cm x 20 cm) will be used to deliver the Qutenza 8% capsaicin to the participants skin.

If a subject meets the qualifications for this study, in addition to their standard of care for their LBP, they can expect to have a total of 5 visits in a 12 month period. Each visit will require subjects to fill out several surveys and receive treatment patches for their LBP (your doctor will decide if participants will need to be retreated at each visit based on your symptoms). The study visits are estimated to take 90 minutes upwards to 120 minutes.

Primary Outcome 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 radiculopathy, 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, at 12 months
Secondary Outcome Measures: Assess changes in body mass index (BMI) in patients receiving the Qutenza 8% capsaicin topical system., A secondary aim is to assess side effects, weight (measured in kg) and height (measured in meters) will be combined to report changes in BMI in kg/m\^2 at each subsequent follow-up visit of patients receiving the Qutenza 8% capsaicin topical system., at 12 months|Assess changes in quality of life and sleep in patients receiving the Qutenza 8% capsaicin topical system., A secondary aim is to assess the quality of life and sleep data will be obtained from the PROMIS 29 subscales, at 12 months|Assess changes in medication and procedural utilization in patients receiving the Qutenza 8% capsaicin topical system., A secondary aim is to assess medication and procedural (lumbar and sacral interventions, including sacroiliac joint injections or radiofrequency ablations, lumbar facet joint injections or radiofrequency ablation, and lumbar or sacral epidural steroid injections) utilization, which will be determined by patient's self-report interview or chart review at each subsequent follow-up visit of patients receiving the Qutenza 8% capsaicin topical system., at 12 months