Cryoneurolysis Versus Radiofrequency Ablation for the Treatment of Chronic Low Back Pain
Active, not recruitingNot applicableNCT06804551
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- A Single-center, Prospective, Double-blind, Randomized Controlled Trial Evaluating Iovera° Lumbar Medial Branch Cryoneurolysis Versus Radiofrequency Ablation for the Treatment of Facet-mediated Chronic Low Back Pain
- Conditions
- Interventions
- Device: iovera system
- Device: Radiofrequency ablation alone
- Sponsor
- University of Kansas Medical Center
- Start date
- 2025-05-13
- Primary completion
- 2027-07
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: Subjects must meet all the following inclusion criteria to be eligible for participation. * Subjects at least 18 years of age at Screening * Chronic low back pain (≥ 3 months) * Successful trial of two diagnostic medial branch blocks * Failure of at least three months of conservative non-operative therapy (e.g., physical therapy, chiropractic care, sleep hygiene, weight loss, spinal injections, NSAIDs, physician-directed exercise program or other appropriate pain medicine) * Able to provide informed consent, adhere to the study visit schedule, and complete all study assessments Exclusion Criteria: Subjects who meet any of the following exclusion criteria will not be eligible for participation in this study. * Active workers' compensation, personal injury, Social Security disability insurance (SSDI), or other litigation/compensation related to the spine * Infection in the back or open wounds in the back * Cancer * Fractures in the back * Pain shooting down the leg * Pain when walking up/downhill * Any back surgery or metal objects in the back * Any implants of any kind in the body * Currently pregnant, nursing, or planning to become pregnant during the study * Blood clots * History of RFA treatment in back * Drug abuse
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT06804551