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

Official title

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

Overview

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.

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 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.

Interventions

• Device 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 take
• Procedure 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 n

Primary outcome measures

• Numeric rating scale (NRS) pain intensity score [Time frame: 360 days after intervention]

Secondary outcome measures (2)

• Change in Functional Disability from baseline using Oswestry Disability Questionnaire [Time frame: 360 days after intervention]
• Change in Patients' Global Impression of Change (PGIC) scale from baseline [Time frame: 360 days after intervention]

Eligibility 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:

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

United States · 1 center

• Montefiore Multidisciplinary Pain Program — The Bronx

Publications

• Leavitt L, Dixon B, Tieppo Francio V, Rohrs J, Hendrix JM. Radiofrequency Ablation. 2026 Jul 6. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK482387/ PMID 29494009
• Winston P, Mills PB, Reebye R, Vincent D. Cryoneurotomy as a Percutaneous Mini-invasive Therapy for the Treatment of the Spastic Limb: Case Presentation, Review of the Literature, and Proposed Approach for Use. Arch Rehabil Res Clin Transl. 2019 Oct 17;1(3-4):100030. doi: 10.1016/j.arrct.2019.100030. eCollection 2019 Dec. PMID 33543059
• Tetzlaff W, Bisby MA. Neurofilament elongation into regenerating facial nerve axons. Neuroscience. 1989;29(3):659-66. doi: 10.1016/0306-4522(89)90138-3. PMID 2500618
• Starr JB, Gold L, McCormick Z, Suri P, Friedly J. Trends in lumbar radiofrequency ablation utilization from 2007 to 2016. Spine J. 2019 Jun;19(6):1019-1028. doi: 10.1016/j.spinee.2019.01.001. Epub 2019 Jan 10. PMID 30639589
• Shaffer JP, Williams VB, Shin SS. Cryoneurolysis for Digital Neuralgia in Professional Baseball Players: A Case Series. Orthop J Sports Med. 2022 May 12;10(5):23259671221096095. doi: 10.1177/23259671221096095. eCollection 2022 May. PMID 35601731
• Sayed D, Grider J, Strand N, Hagedorn JM, Falowski S, Lam CM, Tieppo Francio V, Beall DP, Tomycz ND, Davanzo JR, Aiyer R, Lee DW, Kalia H, Sheen S, Malinowski MN, Verdolin M, Vodapally S, Carayannopoulos A, Jain S, Azeem N, Tolba R, Chang Chien GC, Ghosh P, Mazzola AJ, Amirdelfan K, Chakravarthy K, Petersen E, Schatman ME, Deer T. The American Society of Pain and Neuroscience (ASPN) Evidence-Based PMID 36510616
• Rubin DI. Epidemiology and risk factors for spine pain. Neurol Clin. 2007 May;25(2):353-71. doi: 10.1016/j.ncl.2007.01.004. PMID 17445733
• Rubenstein J, Harvey AW, Vincent D, Winston P. Cryoneurotomy to Reduce Spasticity and Improve Range of Motion in Spastic Flexed Elbow: A Visual Vignette. Am J Phys Med Rehabil. 2021 May 1;100(5):e65. doi: 10.1097/PHM.0000000000001624. No abstract available. PMID 33105153

Identifiers

NCT: NCT07214844 · 2024-16365 · CRS-133

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗