Qutenza for Lower Back Pain
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether a capsaicin patch, called Qutenza, can safely and effectively reduce certain types of lower back pain. The focus is on pain that travels down the leg due to nerve issues in the lower back, known as lumbosacral radiculopathy and neuropathic lower back pain. Participants will use up to four patches per visit, alongside their usual back pain treatments, across five visits in a year. This trial might suit someone who has experienced lower back pain for over three months, especially if it feels like nerve pain.
As a Phase 2 trial, the research measures how well the treatment works in an initial, smaller group of people, offering participants a chance to contribute to early-stage findings.
Do I need to stop my current medications to join the trial?
The trial does not specify if you need to stop taking your current medications. However, if you are using chronic opioids (strong painkillers) regularly, you may not be eligible to participate.
Is there any evidence suggesting that Qutenza 8% capsaicin topical system is likely to be safe for humans?
Research has shown that the Qutenza 8% capsaicin patch is generally safe for use. The FDA has already approved it to treat certain types of nerve pain, such as post-shingles pain and diabetic nerve pain in the feet. Studies indicate that it may cause side effects like redness and a burning sensation at the application site, but these effects are usually mild and resolve quickly. The patch is applied directly to the skin, and most people find that any discomfort subsides shortly.12345
Why are researchers excited about this study treatment?
Unlike the standard treatments for neuropathic lower back pain, which often involve oral medications or injections, Qutenza uses an 8% capsaicin topical system. This high concentration of capsaicin, derived from chili peppers, directly targets and desensitizes overactive pain nerves in the skin, potentially reducing pain more effectively. Researchers are excited because this topical approach offers a non-invasive alternative that might provide relief without the systemic side effects typical of oral pain medications. Additionally, Qutenza's unique delivery method could lead to faster and more localized pain relief, which is a promising advancement for those suffering from this type of pain.
What evidence suggests that Qutenza 8% capsaicin topical system might be an effective treatment for lower back pain?
Research has shown that the Qutenza 8% capsaicin patch effectively relieves pain in conditions like nerve pain. Studies have consistently found that this treatment reduces pain and improves quality of life for individuals with various types of nerve pain. For instance, one study demonstrated a clear decrease in pain after patients used the patch. Additionally, the FDA has already approved Qutenza for treating nerve pain after shingles and diabetic nerve pain in the feet, supporting its potential to help with other nerve-related pain issues. This suggests it might also be effective for lower back pain linked to nerve damage in the current study.45678
Who Is on the Research Team?
Matthew Sherrier
Principal Investigator
Medical University of South Carolina
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Qutenza 8% capsaicin topical system patches for lower back pain and lumbosacral radiculopathy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Qutenza 8% Capsaicin Topical System
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
patients with neuropathic LBP and painful lumbosacral radiculopathy
Find a Clinic Near You
Who Is Running the Clinical Trial?
Medical University of South Carolina
Lead Sponsor
Averitas Pharma, Inc.
Industry Sponsor
Citations
NCT06540456 | Qutenza 8% Capsaicin Topical System for ...
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 ...
The Capsaicin 8% Patch for Neuropathic Pain in Clinical ...
Abstract. Objective. To investigate the response of patients with peripheral neuropathic pain (PNP) to capsaicin 8% patch treatment in a clinical setting.
3.
journals.lww.com
journals.lww.com/painrpts/fulltext/2025/04000/narrative_review_of_the_efficacy_and_safety_of_the.3.aspxNarrative review of the efficacy and safety of the... : PAIN ...
The results show that the HC capsaicin patch consistently provides pain relief and improves quality of life for several pNeP conditions, with increasing ...
DPN - Clinical Results | QUTENZA HCP
Results from a 12-week, double-blind, randomized, placebo-controlled, multicenter study of 369 patients. The least-squares mean change was -1.92 on the ...
Treatment of painful radiculopathies with capsaicin 8% ...
Data was analyzed by patch application site and duration of pain. Results: Topical treatment led to a significant decrease of pain intensity between weeks 1/2 ...
Qutenza 8% Capsaicin Topical System for the Treatment of ...
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 ...
QUTENZA® (capsaicin) patch - accessdata.fda.gov
The safety and effectiveness of QUTENZA in patients younger than 18 years of age have not been studied. 8.5 Geriatric Use. In controlled clinical studies of ...
QUTENZA (capsaicin) for DPN and PHN
QUTENZA (capsaicin) 8% topical system is indicated in adults for the treatment of neuropathic pain associated with postherpetic neuralgia (PHN)
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.