Status:
NOT_YET_RECRUITING
A Prospective Study to Evaluate the Efficacy of Iovera Lumbar Medial Branch Cryoneurolysis Versus Radiofrequency Ablation for the Treatment of Chronic Low Back Pain
Lead Sponsor:
Montefiore Medical Center
Collaborating Sponsors:
Pacira Pharmaceuticals, Inc
Conditions:
Low Back Pain, Chronic
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 st...
Detailed Description
Secondary objectives of this study include: 1. Evaluate safety outcomes (i.e., adverse device effects, serious adverse device effects, and adverse events) related to iovera° treatment; 2. Evaluate cl...
Eligibility Criteria
Inclusion
- 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
- 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:
- Mood disorder (e.g., depression, bipolar)
- Patient Health Questionnaire (PHQ-9) ≥ 12 at Screening
- Psychotic disorder (e.g., schizophrenia)
- Catastrophizing
- Patient Catastrophizing Scale (PCS) score \> 30 at Screening
- Subject received other spine intervention/therapies in the 30 days prior to block administration (e.g., spinal injections, minimally invasive therapies, surgical therapies) at the intended lumbar treatment levels
- Subject received radiofrequency ablation in the low back region ≤ 6 months before study enrollment at the intended lumbar treatment levels
- Pain relief following diagnostic medial branch blocks lasted longer than the duration of the local anesthetic used (i.e., \> 24 hours)
- History, suspicion, or clinical manifestation of:
- Alcohol abuse or dependence
- Illicit drug use
- Opioid abuse or dependence (≥40 mg medication PO/day in past 30 days)
- Given the COVID-19 pandemic, the subject must be medically fit/cleared for surgery by the investigator. If there is a concern about a subject's recent or potential exposure to COVID-19, or if the subject is not medically fit/cleared for surgery due to suspected COVID-19 illness/symptoms (or other serious illness), the subject must be excluded.
Key Trial Info
Start Date :
November 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT07214844
Start Date
November 1 2025
End Date
December 1 2026
Last Update
October 9 2025
Active Locations (1)
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1
Montefiore Multidisciplinary Pain Program
The Bronx, New York, United States, 10461