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

NCT06540456 | Enrolling By Invitation FDA Drug

• 1 other identifier: Pro00134392
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lower Back Pain; Lumbosacral Radiculopathy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Assess changes in body mass index (BMI) in 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.

  at 12 months

• Assess changes in medication and procedural utilization in patients receiving the Qutenza 8% capsaicin topical system.

  at 12 months

Study Arms (1)

Patients with neuropathic LBP and painful lumbosacral radiculopathy

patients with neuropathic LBP and painful lumbosacral radiculopathy

Drug: Qutenza® 8% Capsaicin Topical System

Interventions

Qutenza® 8% Capsaicin Topical System DRUG

Treatment of patients with neuropathic LBP and painful lumbosacral radiculopathy using the Qutenza 8% capsaicin topical system.

Patients with neuropathic LBP and painful lumbosacral radiculopathy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients presenting to the Physical Medicine and Rehabilitation clinics at the Medical University of South Carolina outpatient clinics with complaints of lower back pain and radicular leg pain who meet all inclusion and exclusion criteria will be recruited.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead
• Averitas Pharma, Inc.: collaborator

Study Sites (1)

MUSC Health Nexton Medical Park

Summerville, South Carolina, 29483, United States

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Capsaicin

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Polyunsaturated Alkamides; Amides; Organic Chemicals; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Fatty Acids, Monounsaturated; Fatty Acids, Unsaturated; Fatty Acids; Lipids

Study Officials

• Matthew Sherrier

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor-Faculty

Study Record Dates

• First Submitted: June 28, 2024
• First Posted: August 6, 2024
• Study Start: March 13, 2025
• Primary Completion (Estimated): July 3, 2027
• Study Completion (Estimated): July 3, 2028
• Last Updated: March 20, 2026

Record last verified: 2026-03

Locations

US (1)