A Prospective Study to Evaluate the Efficacy of Iovera Lumbar Medial Branch Cryoneurolysis Versus Radiofrequency Ablation for the Treatment of Chronic Low Back Pain
NCT ID: NCT07214844
Last Updated: 2026-01-28
Study Results
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Basic Information
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RECRUITING
NA
110 participants
INTERVENTIONAL
2026-02-28
2027-03-31
Brief Summary
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* 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.
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Detailed Description
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1. Evaluate safety outcomes (i.e., adverse device effects, serious adverse device effects, and adverse events) related to iovera° treatment;
2. Evaluate clinical outcomes related to iovera° treatment including pain, functional disability, and concomitant medication use (including opioids and analgesics);
3. Evaluate the treatment success and failure rate of iovera° medial branch cryoneurolysis;
4. Evaluate health-related quality of life (HRQoL);
5. Evaluate subject satisfaction with pain management;
6. Identify subgroups of patients who are most and least likely to benefit from iovera° medial branch cryoneurolysis for facet-mediated CLBP.
An adaptive study design will be used in this study. A blinded interim analysis will occur after approximately 56 total subjects, at least 28 per study arm, have completed assessment data for the primary efficacy outcome. The primary purpose of this interim analysis is to evaluate the sample size assumptions.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Radiofrequency ablation (RFA)
Subjects will receive radiofrequency ablation (RFA) to the medial branch nerves of the lumbar spine.
Radiofrequency ablation (RFA)
Subjects will receive a fluoroscopic guided RFA medial branch block in the prone position under asepsis:
* The Right L4, L5, S1 articular pillars are identified with fluoroscopy at each level and the target points are located
* A skin wheal is formed using 5mL 1% Lidocaine and 5mL 0.25% Bupivacaine
* A 20-gauge, 10cm needle with a 10mm active tip is inserted using a 15-degree oblique view and a 15-degree caudad angle onto the waist of each pillar at each level
* Anterior-posterior and oblique neuroforamen views confirm positioning
* Stimulation is performed and recorded to confirm proper needle placement
* A mixture of 3mL of 0.25% Bupivacaine and 2mL of 1% Lidocaine is divided and injected at each level
* A lesion is then performed at each level at 80 degrees centigrade for 60 seconds
* The needles are removed, and bandages applied to the puncture sites
* The same procedure is carried out on the opposite side
iovera cryoneurolysis
Subjects will receive iovera cryoneurolysis to the medial branch nerves of the lumbar spine.
Iovera Medial Branch Cryoneurolysis
The iovera group will receive fluoroscopic guided medial branch cryoneurolysis with the subject in the prone position under asepsis:
* Investigator injects 1% lidocaine at the treatment site using a 25-gauge, 3/4 -inch needle to numb the skin and tissue around the facet joint
* Introducer needle is inserted through the skin wheal to the target medial branch nerve below the junction of the superior articular and transverse process
* The introducer needle is positioned, and an x-ray image is taken to confirm the needle's position
* With the desired introducer needle position confirmed, the iovera Smart Tip is guided through the introducer needle and the handpiece is secured to the Smart Tip. The start/stop button on the iovera° handpiece is then pressed to start the cycle.
* After the cycle is complete, Smart Tip can be removed and next treatment cycle can commence ensuring an overlap of the ice ball
* The needle is removed, and light compression is applied with gauze
Interventions
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Iovera Medial Branch Cryoneurolysis
The iovera group will receive fluoroscopic guided medial branch cryoneurolysis with the subject in the prone position under asepsis:
* Investigator injects 1% lidocaine at the treatment site using a 25-gauge, 3/4 -inch needle to numb the skin and tissue around the facet joint
* Introducer needle is inserted through the skin wheal to the target medial branch nerve below the junction of the superior articular and transverse process
* The introducer needle is positioned, and an x-ray image is taken to confirm the needle's position
* With the desired introducer needle position confirmed, the iovera Smart Tip is guided through the introducer needle and the handpiece is secured to the Smart Tip. The start/stop button on the iovera° handpiece is then pressed to start the cycle.
* After the cycle is complete, Smart Tip can be removed and next treatment cycle can commence ensuring an overlap of the ice ball
* The needle is removed, and light compression is applied with gauze
Radiofrequency ablation (RFA)
Subjects will receive a fluoroscopic guided RFA medial branch block in the prone position under asepsis:
* The Right L4, L5, S1 articular pillars are identified with fluoroscopy at each level and the target points are located
* A skin wheal is formed using 5mL 1% Lidocaine and 5mL 0.25% Bupivacaine
* A 20-gauge, 10cm needle with a 10mm active tip is inserted using a 15-degree oblique view and a 15-degree caudad angle onto the waist of each pillar at each level
* Anterior-posterior and oblique neuroforamen views confirm positioning
* Stimulation is performed and recorded to confirm proper needle placement
* A mixture of 3mL of 0.25% Bupivacaine and 2mL of 1% Lidocaine is divided and injected at each level
* A lesion is then performed at each level at 80 degrees centigrade for 60 seconds
* The needles are removed, and bandages applied to the puncture sites
* The same procedure is carried out on the opposite side
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Pacira Pharmaceuticals, Inc
INDUSTRY
Montefiore Medical Center
OTHER
Responsible Party
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Principal Investigators
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Karina Gritsenko, MD
Role: PRINCIPAL_INVESTIGATOR
Montefiore Medical Center
Locations
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Montefiore Multidisciplinary Pain Program
The Bronx, New York, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Other Identifiers
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CRS-133
Identifier Type: OTHER
Identifier Source: secondary_id
2024-16365
Identifier Type: -
Identifier Source: org_study_id
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