Utilization of 60-Day Peripheral Nerve Stimulation of the Occipital Nerves for the Treatment of Headache: A Prospective Multisite Cohort Study of Health Care Resource Utilization and Clinical Outcomes
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Change in headache impact
研究概览
简要总结
This prospective observational cohort study will evaluate clinical outcomes and health care resource utilization among adults who, independent of research participation, are clinically scheduled to undergo temporary 60-day occipital nerve peripheral nerve stimulation (PNS) as part of routine care for refractory headache disorders.
详细描述
The main purpose of this prospective observational cohort study is to evaluate clinical outcomes and health care resource utilization among adults who, independent of research participation, are clinically scheduled to undergo temporary 60-day occipital nerve peripheral nerve stimulation (PNS) as part of routine care for refractory headache disorders.
The study will assess changes in headache impact, pain intensity, neck-related disability, patient global impression of change, medication utilization, and headache-related health care utilization over 12 months. The anticipated impact of this research is improved understanding of whether occipital PNS delivered in standard clinical practice is associated with better patient-reported outcomes, fewer acute care visits, and lower utilization of health system resources, which may ultimately inform clinical decision-making, quality-of-life improvement, and potential cost savings.
Planned analyses include within-subject longitudinal comparisons from baseline to 60 days and 12 months, site adjusted modeling of utilization outcomes, and exploratory analyses of predictors of response across headache diagnoses and patient subgroups.
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 a headache disorder for which the treating clinician has independently made the clinical decision to proceed with temporary 60-day occipital nerve PNS as part of routine care, including:
- •Occipital neuralgia
- •Chronic migraine
- •Chronic tension-type headache
- •Chronic cluster headache
- •Cervicogenic headache
- •Clinically scheduled to undergo temporary 60-day occipital PNS as part of routine care.
- •Ability to provide informed consent.
排除标准
- •Inability to provide informed consent.
- •Coagulopathy that would prohibit PNS placement.
- •Severe psychiatric illness interfering with participation.
研究组 & 干预措施
Occipital nerve peripheral nerve stimulation (PNS)
Temporary 60-day occipital nerve peripheral nerve stimulation (PNS) as part of routine care for refractory headache disorders.
干预措施: Occipital nerve peripheral nerve stimulation (PNS) (Procedure)
结局指标
主要结局
Change in headache impact
时间窗: 60 days
Change in headache impact will be measured using the HIT-6 measures the impact of headache on daily life. Score range: 36-78; Impact Categories: ≤49: Little to no impact, 50-55: Some impact, 56-59: Substantial impact, ≥60: Severe impact. A reduction in score would indicate an improvement in headache.
Change in health care resource utilization (HCRU)
时间窗: 12 months
Change in HCRU will be assesssed by the change in frequency of emergency department visits for headache-related diagnoses during the 12 months after treatment compared with the pre-treatment period.
次要结局
- Change in numeric rating scale(12 months)
- Change in neck disability index(12 months)
- Change in global impression of change(12 months)
- IMMPACT ≥30% pain reduction(12 months)
- IMMPACT Pain Relief ≥50%(60 days)
- IMMPACT Pain Relief ≥80%(60 days)
- IMMPACT Pain Relief ≥50%(12 months)
- Medication utilization(12 months)
- Healthcare Utilization(12 months)