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

Part of paid clinical trials in Summerville, South Carolina.

Sponsor
Medical University of South Carolina
Study ID
NCT06540456
Status
Enrolling By Invitation

Conditions

  • Lower Back Pain
  • Lumbosacral Radiculopathy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Qutenza® 8% Capsaicin Topical System — DRUG
    Treatment of patients with neuropathic LBP and painful lumbosacral radiculopathy using the Qutenza 8% capsaicin topical system.

Study Details

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.

Key Dates

Start date
Mar 13, 2025
Status verified
Mar 2026
Primary completion
Jul 3, 2027
Completion
Jul 3, 2028

Study Design

Enrollment
50 participants (estimated)

Arms

  • Arm: Patients with neuropathic LBP and painful lumbosacral radiculopathy
    patients with neuropathic LBP and painful lumbosacral radiculopathy

Primary Outcome Measure

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 [ Time Frame: at 12 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
MUSC Health Nexton Medical ParkSummervilleSouth Carolina29483-

Find similar trials in Summerville, SC

By research site
MUSC Health Nexton Medical Park· Summerville, SC

Related Studies