PROLONG Prospective, Multi-center, Open-label, Post-market Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 118
- 试验地点
- 41
- 主要终点
- Mean Change in Pain Assessed by Numerical Rating Scale (NRS) From Baseline to 3 Months
研究概览
简要总结
Spinal cord stimulation (SCS) has been shown to be effective for relieving intractable chronic pain. However, a portion of patients who initially succeed with SCS will eventually lose their therapeutic benefit. Reliable methods have not been identified for restoring neuromodulation benefit to this underserved population, so additional research is required. This study will prospectively observe subjects who utilize Abbott neurostimulation devices after failing to sustain pain relief with their previous SCS system. The effectiveness of Abbott systems in restoring neuromodulation benefit will be evaluated over the course of a two-year follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Patient must provide written informed consent prior to any clinical investigation related procedure.
- •Patient has a spinal cord stimulator implanted for chronic, intractable pain.
- •Patient has inadequate pain relief from their current SCS system.
- •Patient has a pain NRS ≥
- •Physician has determined that the patient's original pain is still addressable with neurostimulation.
排除标准
- •Patient is enrolled, or intends to participate, in a competing clinical study, as determined by Abbott.
- •Patient is seeking care for a new pain complaint outside of the original indication for SCS.
- •Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the Investigator's opinion, could limit the patient's ability to participate in the clinical investigation or to comply with follow-up requirements.
- •Physician has determined that patient's pain relief is inadequate due to a malfunction or damage to the existing system.
- •Patient requires frequent MRI.
- •Patient is involved in active disability litigation related to their pain or seeking worker's compensation.
- •Patient is part of a vulnerable population.
结局指标
主要结局
Mean Change in Pain Assessed by Numerical Rating Scale (NRS) From Baseline to 3 Months
时间窗: From Baseline to 3 months
Numerical Rating Scale (NRS) is a scale which measures pain intensity from 0-10, with 0 being no pain and 10 being worst pain.
Mean Change in Pain Assessed by Numerical Rating Scale (NRS) From Baseline to 6 Months
时间窗: From Baseline to 6 months
Numerical Rating Scale (NRS) is a scale which measures pain intensity from 0-10, with 0 being no pain and 10 being worst pain.
Mean Change in Pain Assessed by Numerical Rating Scale (NRS) From Baseline to 12 Months
时间窗: From Baseline to 12 months
Numerical Rating Scale (NRS) is a scale which measures pain intensity from 0-10, with 0 being no pain and 10 being worst pain.
Mean Change in Pain Assessed by Numerical Rating Scale (NRS) From Baseline to 18 Months
时间窗: From Baseline to 18 months
Numerical Rating Scale (NRS) is a scale which measures pain intensity from 0-10, with 0 being no pain and 10 being worst pain.
Mean Change in Pain Assessed by Numerical Rating Scale (NRS) From Baseline to 24 Months
时间窗: From Baseline to 24 months
Numerical Rating Scale (NRS) is a scale which measures pain intensity from 0-10, with 0 being no pain and 10 being worst pain.
次要结局
- Mean Change in Pain Assessed by Pain Catastrophizing Scale (PCS) From Baseline to 18 Months(From baseline to 18 months)
- Mean Change in Attention to Pain Assessed by Pain Vigilance and Awareness Questionnaire (PVAQ) From Baseline to 3 Months(From baseline to 3 months)
- Mean Change in Attention to Pain Assessed by Pain Vigilance and Awareness Questionnaire (PVAQ) From Baseline to 12 Months(From baseline to 12 months)
- Mean Change in Attention to Pain Assessed by Pain Vigilance and Awareness Questionnaire (PVAQ) From Baseline to 18 Months(From baseline to 18 months)
- Mean Change in Attention to Pain Assessed by Pain Vigilance and Awareness Questionnaire (PVAQ) From Baseline to 24 Months(From baseline to 24 months)
- Mean Change in Pain Assessed by Pain Catastrophizing Scale (PCS) From Baseline to 6 Months(From baseline to 6 months)
- Change in Pain Condition-related Medication Use From Baseline to 24 Months(From baseline to 24 months)
- Mean Change in Health Domains Assessed by PROMIS-29 Scale From Baseline to 3 Months(From baseline to 3 months)
- Mean Change in Health Domains Assessed by PROMIS-29 Scale From Baseline to 12 Months(From baseline to 12 months)
- Mean Change in Health Domains Assessed by PROMIS-29 Scale From Baseline to 18 Months(From baseline to 18 months)
- Mean Change in Health Domains Assessed by PROMIS-29 Scale From Baseline to 24 Months(From baseline to 24 months)
- Mean Change in Pain Assessed by Pain Catastrophizing Scale (PCS) From Baseline to 3 Months(From baseline to 3 months)
- Mean Change in Health Domains Assessed by PROMIS-29 Scale From Baseline to 6 Months(From baseline to 6 months)
- Mean Change in Pain Assessed by Pain Catastrophizing Scale (PCS) From Baseline to 12 Months(From baseline to 12 months)
- Mean Change in Pain Assessed by Pain Catastrophizing Scale (PCS) From Baseline to 24 Months(From baseline to 24 months)
- Mean Change in Attention to Pain Assessed by Pain Vigilance and Awareness Questionnaire (PVAQ) From Baseline to 6 Months(From baseline to 6 months)
- Change in Pain Condition-related Medication Use From Baseline to 3 Months(From baseline to 3 months)
- Change in Pain Condition-related Medication Use From Baseline to 6 Months(From baseline to 6 months)
- Change in Pain Condition-related Medication Use From Baseline to 12 Months(From baseline to 12 months)
- Change in Pain Condition-related Medication Use From Baseline to 18 Months(From baseline to 18 months)