Medical University of South Carolina
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.
Chronic lower back pain (LBP) and lumbosacral radiculopathy are common, disabling, and costly conditions. The lifetime prevalence of LBP is estimated to be greater than 70% in industrialized countries, with a 1-year prevalence of 15-45% and LBP is the most common cause of years lived with disability worldwide. Chronic LBP (defined as LBP lasting less than 3 months) is a complex and heterogeneous condition with nociceptive and neuropathic components. The goals of treatment of chronic LBP and lumbosacral radiculopathy are to reduce pain, maintain function, and prevent future exacerbation. Guide…
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 (M…
Treatment of patients with neuropathic LBP and painful lumbosacral radiculopathy using the Qutenza 8% capsaicin topical system.