Prospective, Single-Arm, Cohort Study on Basivertebral Nerve Ablation With the Intracept Procedure
试验速览
- 阶段
- 4 期
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Oswestry Disability Index (ODI) Change- 6 Months
研究概览
简要总结
This is an independent prospective, noninterventional, single arm post market data collection of the patient-reported effectiveness, ongoing safety, and satisfaction outcomes for patients treated with intraosseous basivertebral nerve ablation using the Intracept Procedure at a single study site.
详细描述
Participants in the study will have three study visits over a period of one-year (one prior to procedure and 2 post their procedure). Study visits will be conducted in person by the principal investigator and/or authorized and trained clinical research coordinators at the study site. Participants will be consented and evaluated for inclusion/exclusion criteria and a baseline collect at the initial visit (prior to procedure). Participants will be followed post intraosseous basivertebral nerve ablation at 1, 3, 6, and 12, and 24 months.
Primary and secondary objectives are based on patient reported outcomes for functional improvement (Oswestry Disability Index), low back pain reduction (Visual Analog Scale), and physical and mental health pre and post procedure (EQ-5D-5L and SF-36).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 84 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients ≥18 years of age
- •Patients who have experienced chronic low back pain for ≥6 months.
- •Patients who have not responded to at least 6 months of conservative care.
- •Patients with Modic type 1 or 2 changes.
排除标准
- •Patients with severe cardiac or pulmonary disease.
- •Patients with active systemic infection or localized infection in the treatment area.
结局指标
主要结局
Oswestry Disability Index (ODI) Change- 6 Months
时间窗: 6 Months
Validated questionnaire of low back pain related disability. Compromised of 10 questions evaluating the impact of low back pain on activities of daily living. The ODI is scored on a scale of 0 (no disability) to 100 (complete disability), with categories of 0-20 (minimal disability), 21-40 (moderate disability), 41-60 (severe disability), 61-80 (crippling back pain), and 81-100 (bed-bound or exaggerating). Comparison of mean ODI baseline to 6 months.
次要结局
- ODI Responder Rate- 6 Months(6 Months)
- Oswestry Disability Index (ODI) Change-12 Months(12 Months)
- Visual Analog Scale (VAS)- 6 Months(6 Months)
- ODI Responder Rate- 12 Months(12 Months)
- Visual Analog Scale (VAS)- 12 Months(12 Months)
- VAS Responder Rate- 6 Months(6 Months)
- VAS Responder Rate-12 Months(12 Months)