Cryoneurolysis vs Radiofrequency Ablation for Lower Back Pain
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial compares two treatments for long-term lower back pain to determine which is more effective. One treatment, Iovera Medial Branch Cryoneurolysis, uses cold on specific nerves in the lower back, while the other uses heat through radiofrequency ablation. Researchers will monitor participants' pain levels and overall health for about 12 months after the procedure. The trial seeks individuals with chronic and severe low back pain that affects daily life and who have not found success with other treatments. Participants will be randomly assigned to one of the two treatments. As an unphased trial, it offers participants the chance to contribute to innovative pain management research and potentially find relief where other treatments have failed.
Do I have to stop taking my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. However, it mentions that you should not have received certain spine interventions or therapies in the 30 days before the trial. It's best to discuss your specific medications with the study team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
In a previous study, iovera cryoneurolysis demonstrated promising safety results. Research indicates that it has received FDA clearance for managing chronic low back pain, confirming it meets safety standards. No major safety issues were reported when used for various types of pain, including spine-related pain.
Studies on radiofrequency ablation (RFA) show it is generally well-tolerated. Reports suggest that many patients experience significant pain relief, with 60% maintaining at least 90% pain relief after 12 months. Side effects are rare, making it a trusted option for long-term pain management.
Both treatments have shown good safety records in studies, making them viable options for treating chronic low back pain.12345Why are researchers excited about this trial's treatments?
Researchers are excited about iovera medial branch cryoneurolysis and radiofrequency ablation (RFA) for lower back pain because they offer innovative ways to target pain-causing nerves. Iovera cryoneurolysis works by using extreme cold to temporarily disrupt nerve function, which can provide pain relief without the need for medications or surgery. RFA, on the other hand, uses heat to disable nerve activity, offering a longer-lasting solution compared to traditional pain relief methods. Both approaches focus on the medial branch nerves of the lumbar spine, directly targeting the source of pain and potentially providing more effective relief than conventional treatments like pain medications or physical therapy.
What evidence suggests that this trial's treatments could be effective for lower back pain?
This trial will compare iovera° cryoneurolysis with radiofrequency ablation (RFA) for treating lower back pain. Research has shown that RFA effectively treats long-lasting low back pain, with studies indicating that about 86% of patients experience reduced pain, and some even achieve complete relief. Pain relief from RFA typically lasts from six months to a year.
In contrast, limited information exists on using iovera° cryoneurolysis for low back pain. This treatment targets specific nerves with cold and has shown promising results in treating knee and shoulder pain. It temporarily stops pain signals from the nerves. However, more research is needed to determine its effectiveness for low back pain. Participants in this trial will receive either iovera° cryoneurolysis or RFA to evaluate their effectiveness in managing lower back pain.12456Who Is on the Research Team?
Karina Gritsenko, MD
Principal Investigator
Montefiore Medical Center
Are You a Good Fit for This Trial?
This trial is for individuals with chronic low back pain who are seeking alternative treatments. Participants should be adults who have experienced lower back pain for an extended period and are in generally stable health to undergo the procedures.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either iovera cryoneurolysis or radiofrequency ablation to the medial branch nerves of the lumbar spine
Follow-up
Participants are monitored for safety and effectiveness after treatment, including pain levels and overall health
Open-label extension (optional)
Participants may opt into continuation of treatment long-term
What Are the Treatments Tested in This Trial?
Interventions
- Iovera Medial Branch Cryoneurolysis
- Radiofrequency ablation (RFA)
Trial Overview
The study compares two different treatments for chronic low back pain: Iovera Medial Branch Cryoneurolysis, which uses cold therapy on nerves, and Radiofrequency Ablation (RFA), a standard heat-based treatment. Patients will be randomly assigned to one of these treatments.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Subjects will receive iovera cryoneurolysis to the medial branch nerves of the lumbar spine.
Subjects will receive radiofrequency ablation (RFA) to the medial branch nerves of the lumbar spine.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Montefiore Medical Center
Lead Sponsor
Pacira Pharmaceuticals, Inc
Industry Sponsor
Dr. Jonathan Slonin
Pacira Pharmaceuticals, Inc
Chief Medical Officer since 2020
BSc in Biomedical Engineering and MD from University of Miami, MBA from George Washington University
Frank D. Lee
Pacira Pharmaceuticals, Inc
Chief Executive Officer since 2024
BSc in Chemical Engineering from Vanderbilt University, MBA from Wharton Graduate School of Business
Citations
A Prospective Study to Evaluate the Efficacy of Iovera ...
A research study is being conducted to compare two treatments for long-term low back pain: One uses the iovera° system, which applies cold ...
2.
ctv.veeva.com
ctv.veeva.com/study/a-prospective-study-to-evaluate-the-efficacy-of-iovera-lumbar-medial-branch-cryoneurolysis-versus-raA Prospective Study to Evaluate the Efficacy of Iovera Lumbar ...
A research study is being conducted to compare two treatments for long-term low back pain: One uses the iovera° system, which applies cold ...
Cryoneurolysis for Facet Mediated Chronic Low Back Pain
This is a single-center, randomized, pilot study in adult subjects with facet mediated CLBP. Thirty (30) subjects are planned for initial enrollment and ...
iovera Clinical Results | Pain Relief Outcomes
See proven cryoneurolysis results with iovera. Clinical data for knee, hip, shoulder, spine, rib & post-surgical pain management.
5.
medinfo.pacira.com
medinfo.pacira.com/2024_AAP_Ferrillo_lower_back_pain_FINAL_ENCORE_PRESENTATION.pdfLumbar Medial Branch Cryoneurolysis Versus ...
• Currently, the data for treatment of low back pain via cryoneurolysis are sparse. Drawing not to scale. For illustrative purposes only. Liquid N2O.
6.
investor.pacira.com
investor.pacira.com/news-releases/news-release-details/pacira-biosciences-receives-fda-510k-clearance-new-ioveradegRelease details
Pacira BioSciences Receives FDA 510k Clearance for New iovera° SmartTip to Manage Chronic Low Back Pain via Long-lasting Medial Branch Nerve ...
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