A Prospective Single Arm Cohort Study of Intraosseous Basivertebral Nerve Ablation
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 150
- 试验地点
- 6
- 主要终点
- Oswestry Disability Index (ODI) Change
研究概览
简要总结
This is an independent prospective, noninterventional, observational post-market data collection of the patient-reported effectiveness, ongoing safety and satisfaction outcomes for patients treated with the Intracept Procedure at a single study site.
详细描述
The Investigator Sponsor will initially approach patients planning to undergo the Intracept Procedure to discuss their interest in learning more about the study. With patient permission, contact information will be forwarded to a third-party research organization which will contact the patient to explain more about the study and to gather Verbal Informed Consent.
Study data will be collected by the University of Utah research staff via 4 telephone study visits under the direction of the Sponsor Investigator. The study research staff will enter the study data directly into a study database and issue the subject stipend after the completion of each study visit.
Data will be analyzed by a statistician under the direction of the Sponsor Investigator for this single-site study.
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
- •All patients scheduled for intraosseous basivertebral nerve ablation with the Intracept Procedure
- •OR Participant had an Intracept Procedure for their low back pain and completed standard of care questionnaires at their procedure appointment.
排除标准
- •Not scheduled for an intraosseous basivertebral nerve ablation with the Intracept Procedure
- •Intracept procedure for different location other than low back pain
结局指标
主要结局
Oswestry Disability Index (ODI) Change
时间窗: 3 months
Validated questionnaire of low back pain related disability. Comprised 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 3 months.
次要结局
- Quadrants of % reduction in low back pain from baseline to each follow-up period.(24 months)
- Responder rates for the Numeric Pain Rating Scale (NPRS)(3 Months)
- PROMIS 29 Change(24 months)
- Combined Responder Rates (improvement thresholds of ODI ≥ 15 and NPRS ≥ 2)(24 months)
- Responder rates for Oswestry Disability Index (ODI)(24 months)
- Low back pain interventions or surgery(24 Months)
- Patient Global Impression of Change (PGIC)(24 Months)
- Patient-reported procedure-related adverse events(24 Months)
- Oswestry Disability Index (ODI) Change(24 months)
- Numeric Pain Rating Scale (NPRS)(24 months)
- Responder rates the Numeric Pain Score(12 Months)
- Low back pain injections(24 Months)
- Responder rates for the Numeric Pain Score(24 Months)
- Narcotic use(24 Months)
- Work Impact(12 Months)
- Oswestry Disability Index (ODI) Change(12 months)
- Numeric Pain Rating Scale (NPRS)(3 months)
- Numeric Pain Rating Scale (NPRS)(12 months)
- Combined Responder Rates (improvement thresholds of ODI ≥ 15 and NPRS ≥ 2)(3 months)
- Combined Responder Rates (improvement thresholds of ODI ≥ 15 and NPRS ≥ 2)(12 months)
- PROMIS 29 Change(3 months)
- PROMIS 29 Change(12 months)
- Quadrants of % reduction in low back pain from baseline to each follow-up period.(3 months)
- Quadrants of % reduction in low back pain from baseline to each follow-up period.(12 months)
- Low back pain injections(12 Months)
- Responder rates for Oswestry Disability Index (ODI)(3 months)
- Responder rates for Oswestry Disability Index (ODI)(12 months)
- Narcotic use(3 Months)
- Narcotic use(12 Months)
- Low back pain injections(3 Months)
- Low back pain interventions or surgery(3 Months)
- Low back pain interventions or surgery(12 Months)
- Patient Global Impression of Change (PGIC)(3 Months)
- Patient Global Impression of Change (PGIC)(12 Months)
- Patient-reported procedure-related adverse events(3 Months)
- Patient-reported procedure-related adverse events(12 Months)
研究者
Zack McCormick
Principal Investigator; Associate Professor
University of Utah