Who is eligible for clinical trial NCT06804551?

Participants must meet the protocol's inclusion criteria for Chronic Low-back Pain. The stated age range is 18 Years. Confirm all requirements with the study coordinator.

Does clinical trial NCT06804551 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-08-11

Cryoneurolysis Versus Radiofrequency Ablation for the Treatment of Chronic Low Back Pain (NCT06804551)

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

🔵 Active, Not Recruiting Observational / Diagnostic ⚙️ Medical Device Protocol Sponsor: University of Kansas Medical Center

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (6 items) and avoid the listed exclusions (13 items).

Location: University of Kansas Medical Center — Kansas City, Kansas

Age range: 18 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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

Usually NOT eligible if any of the following apply:

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

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

University of Kansas Medical Center — Kansas City, Kansas

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in Chronic Low-back Pain

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Psilocybin Therapy for Chronic Low Back Pain — San Francisco, California
Transcutaneous Spinal Cord Stimulation for Chronic Low Back Pain — San Francisco, California
Evaluation of Multi-Tined Expandable Electrode (MEE) Efficacy and Safety in Treatment of Lumbar Facet Arthropathy by Radiofrequency Neurotomies Compared to Conservative Medical Management. — Kansas City, Kansas
Psilocybin in Chronic Low Back Pain and Depression — Baltimore, Maryland

Explore by condition: All Chronic Low-back Pain clinical trials

💡 How to Participate

Check the checklist above to see if you may qualify.
Review the official NIH record below to find the coordinating site.
Ask about the visit schedule, what is covered at no cost, and any travel support.
Confirm with your own doctor before making a decision.

🏛️ View Official NIH Record ↗