A Single-center, Randomized, Pilot Study to Assess Iovera° Lumbar Medial Branch Cryoneurolysis vs Lumbar Radiofrequency Ablation for Facet Mediated Chronic Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Safety of Cryoneurolysis as Compared to Radiofrequency Ablation (RFA)
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Open label
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
- •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.
结局指标
主要结局
Safety of Cryoneurolysis as Compared to Radiofrequency Ablation (RFA)
时间窗: 0-12 months
Safety will be assessed as the number of subjects with reported treatment-related adverse related to cryoneurolysis or RFA.
次要结局
- Pain Intensity as Measured by 11-point Numeric Rating Scale (NRS) at 12 Month Follow up(12 months)