Cryoneurolysis for Facet Mediated Chronic Low Back Pain

Study Overview
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Brief Summary
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This is a single-center, randomized, pilot study in adult subjects with facet mediated CLBP. Thirty (30) subjects are planned for initial enrollment and will be randomized 1:1 to receive ioveraº medial branch cryoneurolysis or radiofrequency ablation.

Detailed Description
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This is a single-center, randomized, pilot study in adult subjects with facet mediated CLBP. Thirty (30) subjects are planned for initial enrollment and will be randomized 1:1 to receive ioveraº medial branch cryoneurolysis or radiofrequency ablation. This study is designed to determine if a full efficacy RCT can be successfully conducted using the procedures and protocols described in the current pilot study protocol, or if protocol modifications are necessary before moving forward with a full efficacy RCT. Furthermore, the study will assess the feasibility of the outcome measurements employed, construct a foundation for sample size calculation, and the acceptability/practicality of conducting the full efficacy RCT. Randomization to treatment groups according to the randomization assignment will be performed on the day of treatment. The treatment groups are: Group 1: subjects will receive iovera° cryoneurolysis to the medial branch nerves of the lumbar spine Group 2: subjects will receive RFA to the medial branch nerves of the lumbar spine

Official Title
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A Single-center, Randomized, Pilot Study to Assess Iovera° Lumbar Medial Branch Cryoneurolysis vs Lumbar Radiofrequency Ablation for Facet Mediated Chronic Low Back Pain

Conditions
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Low Back Pain, Facet Joint Pain

Intervention / Treatment
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* Device: iovera system
* Device: Radiofrequency ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female volunteers, at least 18 years of age at screening Primary complaint of axial low-back pain suggestive of unilateral or bilateral facet joint involvement (i.e., facet mediated CLBP) Low back pain is chronic (i.e., > 3 months' duration) Low back pain score of ≥ 4 (i.e., moderate pain) on the 0 to 10 NRS or functional impairment 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 50% relief of primary (index) pain for the duration of the local anesthetic used or history of a positive response to prior radiofrequency treatment (i.e., ≥ 6 months prior to enrollment) Failure of at least three months of conservative non-operative therapy (e.g., physical therapy, chiropractic care, spinal injections, NSAIDs or other appropriate analgesics), Able to provide informed consent, adhere to the study visit schedule, and complete all study assessments Exclusion Criteria: 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 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 devices, 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 3.5-inch needle cannot be used in the low back region because of habitus Severe chronic pain disorder that in the opinion of the investigator may impact postsurgical outcomes Presence of any of the following: Spinal neurostimulator Intrathecal analgesic drug pump Current manifestation of poorly controlled mental illness that in the opinion of the investigator may meaningfully impact treatment outcomes, including any of the following: Mood disorder (e.g., major depression, bipolar) Psychotic disorder (e.g., schizophrenia) Subject received other spine intervention/therapies in the 30 days prior to block administration (e.g., spinal injections, minimally invasive therapies, surgical therapies) Subject received radiofrequency ablation in the low back region ≤ 6 months before study enrollment History, suspicion, or clinical manifestation of: Alcohol abuse or dependence Illicit drug use Opioid abuse or dependence (≥40 mg MED PO/day in past 30 days) Given the COVID-19 pandemic, the subject must be medically fit/cleared for treatment 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 treatment due to suspected COVID-19 illness/symptoms (or other serious illness), the subject must be excluded per Exclusion criterion #4.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomization to treatment groups according to the randomization assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cryoneurolysis<br>Subjects will receive iovera° cryoneurolysis to the medial branch nerves of the lumbar spine | Device: iovera system<br>* The iovera° system consists of a reusable, portable Handpiece, along with single patient use sterile Smart Tips (i.e., cryoprobes) and disposable nitrous oxide (N2O) cartridges. The iovera° system produces the desired effect through initiation of a cooling cycle. Each cooling cycle is initiated by fully inserting the Smart Tip into the selected procedure site and activating the cryogen flow. The Smart Tip needles are made of stainless steel and have a closed tip, fully enclosing the cryogen. The 190 Smart Tip will be used in this study.<br>* Other names: iovera;|
| Active Comparator: Radiofrequency ablation<br>Subjects will receive RFA to the medial branch nerves of the lumbar spine | Device: Radiofrequency ablation<br>* The RFA system consists of a Cosman, G4 Generator. The needles used are 20-gauge, 10cm long with a 10mm active tip manufactured by Cosman. A grounding pad, also manufactured by Cosman, is placed on the upper thigh for each procedure and connected to the G4 Generator.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of cryoneurolysis as compared to radiofrequency ablation (RFA) | Safety will be assessed as the number of subjects with reported treatment-related adverse related to cryoneurolysis or RFA. | 0-12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain intensity as measured by 11-point Numeric Rating Scale (NRs) | Subjects will evaluate their pain in the low back region using an 11-point Numeric Rating Scale (NRS), where 0=no pain and 10=worst possible pain. Subjects will evaluate how much pain they are currently experiencing and their worst and average level of pain over the past 24 hours. | 0-12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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low back pain