NCT00768872已完成不适用
Neuro Ambulatory Data Recorder (ADR) Spinal Cord Stimulation (SCS) Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 3
- 主要终点
- Change from Baseline in Physical Activity (total centi-Gs per 5.125 seconds)
研究概览
简要总结
The purpose of this study is to characterize a patient's activity levels before and after spinal cord stimulation therapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •18 years of age or older
- •Candidate for SCS device trial
- •Subject is ambulatory
- •Diagnosed with low back pain or low back pain plus leg pain for at least 6 months
- •Undergoing treatment for low back pain or low back pain plus leg pain
- •Does not have or has not had a previous SCS implant
- •Willing and able to complete protocol requirements
- •Willing and able to sign the study-specific Informed Consent form
- •Male or non-pregnant female
排除标准
- •Have plans to enroll in another clinical study during their participation in this study, or are currently enrolled in a clinical study that could interfere in participation in the trial or affect the scientific soundness of this study
- •Cancer or any other malignant disease
- •Present or past diagnosis of schizophrenia or of delusional, psychotic, or dissociative disorder
- •A pain-related surgery in the previous 12 weeks of enrollment, the intent to undergo surgery during the period of the study
- •Non-English speaking or an inability to complete questionnaires accurately
结局指标
主要结局
Change from Baseline in Physical Activity (total centi-Gs per 5.125 seconds)
时间窗: 4, 12, 24 weeks post implant
Change from Baseline in Posture Parameters (minutes per 24 hours)
时间窗: 4, 12, 24 weeks post implant
次要结局
未报告次要终点
研究者
研究点 (3)
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