A Prospective Study to Evaluate the Efficacy of Iovera Lumbar Medial Branch Cryoneurolysis Versus Radiofrequency Ablation for the Treatment of Chronic Low Back Pain

NCT07214844 | Recruiting DMC FDA Device

• 2 other identifiers: 2024-16365CRS-133
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Low Back Pain, Chronic

Keywords

Iovera; Radiofrequency ablation; cryoneurolysis; low back pain; lumbar medial branch

Outcome Measures

Primary Outcomes (1)

• Numeric rating scale (NRS) pain intensity score

  Subjects will evaluate their pain in the low back region using an 11-point NRS where 0=no pain and 10=worst possible pain, such that higher scores are associated with greater pain intensity. * Pain intensity scores (using the NRS) measured as "On a scale from 0 to 10, where 0 equals no pain and 10 equals the worst possible pain, how much pain are you experiencing in your low back right now? * Pain intensity scores (using the numeric rating scale; NRS) measured as "On a scale from 0 to 10, where 0 equals no pain and 10 equals the worst possible pain, what was the worst pain in your low back in the last 24 hours?" * Pain intensity scores (using the NRS) measured as "On a scale from 0 to 10, where 0 equals no pain and 10 equals the worst possible pain, what was the average pain in your low back in the last 24 hours?" Mean numeric pain intensity rating scores will be summarized by study arm using basic descriptive statistics.

  360 days after intervention

Secondary Outcomes (2)

• Change in Functional Disability from baseline using Oswestry Disability Questionnaire

  360 days after intervention

• Change in Patients' Global Impression of Change (PGIC) scale from baseline

  360 days after intervention

Study Arms (2)

iovera cryoneurolysis

EXPERIMENTAL

Subjects will receive iovera cryoneurolysis to the medial branch nerves of the lumbar spine.

Device: Iovera Medial Branch Cryoneurolysis

Radiofrequency ablation (RFA)

ACTIVE COMPARATOR

Subjects will receive radiofrequency ablation (RFA) to the medial branch nerves of the lumbar spine.

Procedure: Radiofrequency ablation (RFA)

Interventions

Iovera Medial Branch Cryoneurolysis DEVICE

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

iovera cryoneurolysis

Radiofrequency ablation (RFA) PROCEDURE

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

Radiofrequency ablation (RFA)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Montefiore Medical Center: lead
• Pacira Pharmaceuticals, Inc: collaborator

Study Sites (1)

Montefiore Multidisciplinary Pain Program

The Bronx, New York, 10461, United States

RECRUITING

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MeSH Terms

Conditions

Low Back Pain; Bronchiolitis Obliterans Syndrome

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Karina Gritsenko, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karina Gritsenko, MD

CONTACT

609-369-0344; kgritsen@montefiore.org

Rafi Khandaker, BA

CONTACT

9297152343; rkhandaker@montefiore.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 1:1 randomization

Study Record Dates

• First Submitted: October 6, 2025
• First Posted: October 9, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)