Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID07214844
A Prospective, Randomized, Assessor Blind Study Comparing Iovera Lumbar Medial Branch Cryoneurolysis Versus Radiofrequency Ablation for Facet-mediated Chronic Low Back Pain
Led by Montefiore Medical Center · Updated on 2026-04-23
110
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
M
Montefiore Medical Center
Lead Sponsor
P
Pacira Pharmaceuticals, Inc
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are comparing two treatments for people with long-term chronic low back pain caused by facet joint problems. The study evaluates the effectiveness of the iovera system, which applies cold to certain nerves, versus the standard treatment called radiofrequency ablation, which uses heat. The goal is to determine which treatment better reduces back pain over time. The study also looks at safety, pain relief, impact on daily function, medication use, quality of life, and patient satisfaction. Subgroups likely to benefit most from the iovera treatment will be identified, and an interim analysis will assess study progress. Participants will be randomly assigned to one of two groups: one receiving iovera cryoneurolysis and the other undergoing radiofrequency ablation. Both procedures use imaging guidance to target nerves in the lower back. The iovera treatment involves numbing the skin, inserting a needle to the nerve, and applying cold cycles with the device. Radiofrequency ablation requires numbing, needle placement confirmed by stimulation, injection of anesthetics, and heating the nerve at 80 degrees Celsius for one minute. Treatments are performed on specific lumbar spine nerves related to the pain. Each participant will be monitored for about 12 months after treatment, with the entire study lasting roughly 14 months per person. Researchers will assess pain levels using a numeric rating scale, functional disability, patient impression of change, and overall health. Safety outcomes, medication use, and quality of life will also be tracked. Follow-up includes regular visits to evaluate treatment success, adverse events, and patient satisfaction with pain management.
CONDITIONS
Brief Title
A Prospective Study to Evaluate the Efficacy of Iovera Lumbar Medial Branch Cryoneurolysis Versus Radiofrequency Ablation for the Treatment of Chronic Low Back Pain
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Subjects must be at least 18 years old at screening
- Primary complaint of axial low-back pain indicating bilateral facet joint involvement confirmed by provocative testing
- Chronic low back pain lasting 3 months or more
- Moderate to severe low back pain with a score of 5 to 9 on a 0 to 10 numeric rating scale at screening
- Functional impairment of 30% or more on the Oswestry Disability Index at screening
- Successful trial of two diagnostic medial branch blocks with local anesthetic only showing at least 80% pain relief
- Failure of at least three months of conservative non-operative therapy such as physical therapy, chiropractic care, or analgesics
- Ability to provide informed consent and comply with study visit schedule and assessments
You will not qualify if you...
- Active workers' compensation, personal injury, Social Security disability insurance, or other spine-related litigation/compensation
- Serious spinal disorders confirmed by MRI such as suspected cauda equina syndrome, infection, tumor, traumatic fracture, systemic inflammatory spondyloarthropathy, lumbar radiculopathy/radiculitis, neurogenic claudication
- Prior lumbar spinal fusion surgery at intended treatment levels
- Comorbidities affecting study participation including lumbar radiculopathy and neuropathic pain disorder
- Pregnant, nursing, or planning pregnancy during the study
- Known contraindications to the study device including cryoglobulinemia, paroxysmal cold hemoglobinuria, cold urticaria, Raynaud's disease, infected wounds near treatment site, or coagulopathy
- Severe chronic pain disorder impacting outcomes
- Presence of spinal neurostimulator, intrathecal analgesic pump, or cardiac implantable device
- Poorly controlled mental illness or catastrophizing impacting outcomes, including mood disorders with PHQ-9 score 12 or higher, psychotic disorders, or catastrophizing with PCS score above 30
- Spine interventions or therapies at lumbar levels within 30 days prior to block administration
- Radiofrequency ablation in low back within 6 months prior to enrollment
- Pain relief from diagnostic blocks lasting longer than local anesthetic duration
- History or suspicion of alcohol abuse, illicit drug use, opioid abuse or dependence exceeding 40 mg per day
- Not medically fit or cleared for surgery due to COVID-19 concerns or other serious illness
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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2
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Single treatment visit
Participants receive either iovera medial branch cryoneurolysis or radiofrequency ablation (RFA) to the medial branch nerves of the lumbar spine to treat chronic low back pain.
1 treatment visit (in-person)
Follow-up
Duration - Up to 360 days after intervention
Participants are monitored over time to assess pain intensity, functional disability, and overall satisfaction with pain management after treatment.
Multiple follow-up visits over 12 months
Trial Site Locations
Total: 1 location
1
Montefiore Multidisciplinary Pain Program
The Bronx, New York, United States, 10461
Actively Recruiting
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Research Team
K
Karina Gritsenko, MD
R
Rafi Khandaker, BA
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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