Clinical Trial

Cryoneurolysis Versus Radiofrequency Ablation for the Treatment of Chronic Low Back Pain

Active, Not Recruiting
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Summary
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.
Protocol Amendment History 3 changes
critical Trial status changed: Enrolling by Invitation → Active, Not Recruiting 2026-08-14
notable Primary completion pushed: 2026-05 -> 2027-07 2026-08-14
minor Completion pushed: 2026-05 -> 2027-07 2026-08-14
Trial Details
NCT Number NCT06804551
Lead Sponsor University of Kansas Medical Center
Conditions Chronic Low-back Pain
Enrollment 30 participants
Start Date 2025-05-13
Primary Completion 2027-07 (estimated)
Study Completion 2027-07 (estimated)
Updated on ClinicalTrials.gov 2026-08-13