Temporal Trends and Predictors of Clinical Response Following Basivertebral Nerve (BVN) Ablation: A Prospective Observational Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 3
- 主要终点
- Percentage of participants achieving clinical response
研究概览
简要总结
Basivertebral nerve ablation (BVNA) is a minimally invasive procedure approved for vertebrogenic low back pain. While early studies support its efficacy, real-world evidence is still evolving, particularly regarding the trajectory of pain relief and functional improvement over time, and predictors of clinical response. This study aims to evaluate clinical outcomes longitudinally following BVNA and identify baseline predictors of response.
详细描述
Primary Objective:
• To determine the proportion of patients achieving clinical response (defined as ≥50% reduction in VAS or ≥15-point improvement in ODI) following BVNA.
Secondary Objectives:
- To assess changes in PROMIS-7, PAVS, and other patient-reported outcomes.
- To determine the incidence of further interventions such as epidural steroid injections (ESIs) or surgeries.
- To evaluate temporal trends in response and adverse events. A total of 11 visits inclusive of follow up visits with schedule for study intervals. 1 baseline visit, 8 virtual/ phone weekly visits, 1 3-month virtual visit , 1 6-month , 1 12-month and 1 24-month visit.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Diagnosis of chronic axial low back pain with vertebrogenic features
- •Scheduled for BVN ablation
- •Able to provide informed consent
- •Capable of participating in weekly virtual/telephone follow-up for 8 weeks and in- person or remote follow-up at 3 and 6 months through 2 years
排除标准
- •Prior spinal neuromodulation therapy (e.g., spinal cord stimulation or intrathecal pump) within the past 6 months
- •Active substance use disorder or uncontrolled psychiatric illness that may interfere with participation
- •Cognitive impairment limiting ability to complete surveys or provide informed consent
- •Pregnancy
- •Incarceration or current status as a prisoner
结局指标
主要结局
Percentage of participants achieving clinical response
时间窗: 2 years
Clinical response defined as a ≥50% reduction in pain intensity from baseline as measured by the Visual Analog Scale (VAS) or a ≥15-point improvement in the Oswestry Disability Index (ODI) score
次要结局
- Change in PROMIS-7 Global Health Score(2 years)
- Percentage of participants with incresed physical activity assessed using Physical Activity Vital Sign (PAVS)(2 years)
- Incidence of spine-related interventions(2 years)
- Patient Global Impression of Change (PGIC) score(2 years)