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Patients with neuropathic LBP and painful lumbosacral radiculopathy for Lower Back Pain

N/A
Waitlist Available
Led By Matthew Sherrier
Research Sponsored by Medical University of South Carolina
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 12 months
Awards & highlights
No Placebo-Only Group

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.

Eligible Conditions
  • Lower Back Pain
  • Sciatica

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
Assess changes in body mass index (BMI) 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.
Assess changes in quality of life and sleep in patients receiving the Qutenza 8% capsaicin topical system.

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Patients with neuropathic LBP and painful lumbosacral radiculopathyExperimental Treatment1 Intervention
patients with neuropathic LBP and painful lumbosacral radiculopathy

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Who is running the clinical trial?

Medical University of South CarolinaLead Sponsor
969 Previous Clinical Trials
7,399,307 Total Patients Enrolled
Averitas Pharma, Inc.Industry Sponsor
2 Previous Clinical Trials
558 Total Patients Enrolled
Matthew SherrierPrincipal InvestigatorMedical University of South Carolina
~33 spots leftby Jul 2027