A Prospective Study to Evaluate the Efficacy of Iovera Lumbar Medial Branch Cryoneurolysis Versus Radiofrequency Ablation for the Treatment of Chronic Low Back Pain
RecruitingNot applicableNCT07214844
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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)
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.
Study details
- Official title
- A Prospective, Randomized, Assessor Blind, Active-controlled, Single-center Study to Evaluate the Efficacy of Iovera Lumbar Medial Branch Cryoneurolysis Versus Radiofrequency Ablation for the Treatment of Facet-mediated Chronic Low Back Pain
- Conditions
- Interventions
- Device: Iovera Medial Branch Cryoneurolysis
- Procedure: Radiofrequency ablation (RFA)
- Sponsor
- Montefiore Medical Center
- Collaborators
- Pacira Pharmaceuticals, Inc
- Start date
- 2026-04-16
- Primary completion
- 2028-05
- 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 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 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 * Serious spinal disorders (verified on magnetic resonance imaging (MRI)) that may impact outcomes, including any of the following: 1. Suspected cauda equina syndrome (e.g., bowel/bladder dysfunction) 2. Infection 3. Tumor 4. Traumatic fracture 5. Systemic inflammatory spondyloarthropathy 6. Lumbar radiculopathy/radiculitis (i.e., root irritation and deficit) 7. 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: 1. Cryoglobulinemia 2. Paroxysmal cold hemoglobinuria 3. Cold urticaria 4. Raynaud's disease 5. Open and/or infected wounds at or near the treatment site 6. Coagulopathy * Severe chronic pain disorder that in the opinion of the investigator may impact study…
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07214844