A Prospective Study to Evaluate the Efficacy of Iovera Lumbar Medial Branch Cryoneurolysis Versus Radiofrequency Ablation for the Treatment of Chronic Low Back Pain

Recruiting now · Not applicable

Conditions studied: Low Back Pain, Chronic

In brief

A research study is being conducted to compare two treatments for long-term low back pain: * One uses the iovera° system, which applies cold to certain nerves in the lower back. * The other is the standard treatment called radiofrequency ablation, which uses heat. The primary objective is to find out which treatment works better to reduce back pain. Participants in this study will be randomly placed in one of the two treatment groups. The clinical research team will check on participant pain levels and overall health before and after the procedure for about 12 months. The entire study will last about 14 months for each participant.

Key facts

Study ID: NCT07214844
Run by: Montefiore Medical Center
People needed: 110
Starts: 2026-04-16
Expected to finish: 2028-05-01
Last updated by the study team: 2026-06-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Subjects must meet all of the following inclusion criteria to be eligible for participation:
Subjects at least 18 years of age at Screening
Primary complaint of axial low-back pain suggestive of bilateral facet joint involvement (i.e., facet mediated CLBP) by evidence of provocative testing (e.g., axial loading, paraspinal tenderness)
Low back pain is chronic (i.e., ≥ 3 months' duration)
Low back pain is moderate to severe (score of ≥ 5 to ≤ 9) on the 0 to 10 NRS at Screening
Low back pain causes functional impairment (≥ 30% on ODI) at Screening
Successful trial of two diagnostic medial branch blocks consisting of two positive blocks with local anesthetic only (i.e., no steroids) that results in at least 80% relief of primary (index) pain for the duration of the local anesthetic used
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 analgesics)
Able to provide informed consent, adhere to the study visit schedule, and complete all study assessment

You may not qualify if…

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
Serious spinal disorders (verified on magnetic resonance imaging (MRI)) that may impact outcomes, including any of the following:
Suspected cauda equina syndrome (e.g., bowel/bladder dysfunction)
Infection
Tumor
Traumatic fracture
Systemic inflammatory spondyloarthropathy
Lumbar radiculopathy/radiculitis (i.e., root irritation and deficit)
Neurogenic claudication Prior lumbar spinal fusion surgery at the intended treatment levels
Comorbidity that, in the judgment of the Investigator, may affect the subject's ability to participate in the study including lumbar radiculopathy and neuropathic pain disorder
Currently pregnant, nursing, or planning to become pregnant during the study
Known contraindication to study device, including any of the following:
Cryoglobulinemia
Paroxysmal cold hemoglobinuria
Cold urticaria
Raynaud's disease
Open and/or infected wounds at or near the treatment site
Coagulopathy
Severe chronic pain disorder that in the opinion of the investigator may impact study outcomes
Presence of any of the following:
Spinal neurostimulator
Intrathecal analgesic drug pump
Cardiac implantable device
Current manifestation of poorly controlled mental illness or catastrophizing that in the opinion of the investigator may meaningfully impact treatment outcomes, including any of the following:

Where it is running

Montefiore Multidisciplinary Pain Program — The Bronx, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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