Cryoneurolysis vs Radiofrequency Ablation for Low Back Pain
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Cryoneurolysis for low back pain?
How does cryoneurolysis differ from other treatments for low back pain?
Cryoneurolysis is unique because it uses extreme cold to temporarily disable nerves that cause pain, offering an alternative to traditional methods like radiofrequency ablation, which uses heat. This approach can be effective for chronic pain conditions and may provide temporary relief, allowing for repeated treatments if successful.23678
What is the purpose of this trial?
Low back pain (LBP) is the leading cause of disability worldwide. Currently available treatment options for treating low back facet joint pain include acupuncture, pain medications, psychotherapy, anti-inflammatory steroid injections into the joints, exercise, physical therapy, rest, chiropractic treatments, surgery, and radiofrequency ablation (RFA). RFA uses radio waves to target and burn the nerves that send the pain signals to the participant's brain. The purpose of this study is to compare the standard treatment of RFA to a newer therapy called iovera°. The iovera° system is a newer procedure for nerve pain that freezes the targeted nerves leading to a temporary block of the nerve without causing any permanent damage to the nerve. With the nerve blocked, pain is immediately relieved. The nerve reconnects over time and goes back to working exactly as it did before the procedure. The investigators want to see if iovera° therapy is effective in treating people with facet joint-mediated chronic low back pain (CLBP).If the participant decide to participate in the study, the investigators will ask the participant to undergo either an RFA or iovera° procedure to treat the participant's CLBP. After the procedure, the investigators will ask the participant to complete surveys to track the participant's response to the procedure at 15 time points over a 1-year period. These time points consist of phone calls and online surveys.
Research Team
Neil A Segal, MS, MD
Principal Investigator
University of Kansas Medical Center
Eligibility Criteria
This trial is for individuals with chronic low back pain who have not found relief through standard treatments. Participants will undergo either Radiofrequency Ablation (RFA) or the iovera° system procedure and must be willing to complete surveys over a year to track their pain levels.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo either Radiofrequency Ablation (RFA) or iovera° procedure to treat chronic low back pain
Follow-up
Participants are monitored for safety and effectiveness after treatment through surveys and phone calls
Treatment Details
Interventions
- Cryoneurolysis
- Radiofrequency Ablation
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Kansas Medical Center
Lead Sponsor