Comparing Iovera cold nerve‑freezing versus radiofrequency heat treatment for chronic lumbar facet-related low back pain
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
This test compares Iovera's cold-based nerve-freezing with standard radiofrequency heat treatment to see which reduces long-term low back pain in adults with suspected facet-joint pain.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Montefiore Medical Center Academic / other |
| Locations | 1 site (The Bronx, New York) |
| Trial ID | NCT07214844 on ClinicalTrials.gov |
What this trial studies
This randomized study assigns adults with chronic, moderate-to-severe lumbar facet-mediated back pain to receive either Iovera medial branch cryoneurolysis or standard radiofrequency ablation. Eligible participants must have had two diagnostic medial branch blocks with at least 80% temporary pain relief and have failed at least three months of conservative therapy. Investigators will track pain, function, medication use, safety, quality of life, and patient satisfaction over about 12 months, with each participant in the study for roughly 14 months. An adaptive design includes a blinded interim analysis after approximately 56 subjects to reassess sample size assumptions.
Who should consider this trial
Good fit: Adults (≥18) with chronic (≥3 months), moderate-to-severe axial low back pain thought to be facet-mediated who achieved ≥80% relief from two diagnostic medial branch blocks and have failed ≥3 months of conservative care.
Not a fit: Patients whose pain is not facet-joint related, who have low pain scores (<5), or who did not have positive diagnostic medial branch blocks are unlikely to receive benefit from these procedures.
Why it matters
Potential benefit: If successful, the Iovera approach could provide longer or comparable pain relief with a different side-effect profile and broaden non-surgical options for facet-mediated chronic low back pain.
How similar studies have performed: Radiofrequency ablation is an established treatment for facet-mediated back pain, while medial branch cryoneurolysis (Iovera) has shown promising but limited comparative evidence to date.
Eligibility criteria
Show full inclusion / exclusion criteria
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 outcomes
* Presence of any of the following:
1. Spinal neurostimulator
2. Intrathecal analgesic drug pump
3. 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:
1. Mood disorder (e.g., depression, bipolar)
Patient Health Questionnaire (PHQ-9) ≥ 12 at Screening
2. Psychotic disorder (e.g., schizophrenia)
3. 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)
1. History, suspicion, or clinical manifestation of:
2. Alcohol abuse or dependence
3. 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.
Where this trial is running
The Bronx, New York
- Montefiore Multidisciplinary Pain Program — The Bronx, New York, United States (Recruiting)
Study contacts
- Principal investigator: Karina Gritsenko, MD — Montefiore Medical Center
- Study coordinator: Karina Gritsenko, MD
- Email: kgritsen@montefiore.org
- Phone: 609-369-0344
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.