Prospective Evaluation of the Optimal SCS Trial Length
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Determination of the Minimum SCS Trial Duration Predictive of Clinical Outcomes
研究概览
简要总结
This study aims to determine the ideal length of a spinal cord stimulation (SCS) trial period by analyzing daily pain scores, patient satisfaction, and when patients decide whether to proceed with permanent implantation. The primary goal is to identify the shortest trial duration that can reliably predict SCS success. A secondary goal is to compare SCS trial outcomes with patient-reported health measures (PROMIS domains) and recommendations from the SCS E-Health Tool to evaluate how well these tools predict treatment candidacy and outcomes.
详细描述
Spinal cord stimulation (SCS) is an established treatment for chronic pain and is typically preceded by a temporary trial period to evaluate treatment effectiveness before permanent implantation. Standard SCS trial durations generally range from 3 to 7 days, although some trials may be extended up to 15 days. These timeframes are largely intended to minimize the risk of epidural infection associated with prolonged epidural lead placement. However, there is limited evidence defining the optimal duration of an SCS trial, raising the possibility that many trials may be longer than clinically necessary (1).
Reducing the duration of SCS trials could provide several clinical benefits. Shorter trials may decrease the risk of infection, reduce the need for prophylactic antibiotic exposure, and minimize the length of time patients must interrupt antiplatelet or anticoagulant therapy when applicable. Determining the shortest trial duration that reliably predicts treatment success could improve patient safety while streamlining clinical care.
This study aims to identify the optimal duration of the SCS trial by evaluating daily pain scores, patient satisfaction, and the timing of patients' decisions to proceed with permanent SCS implantation. The primary objective is to determine the minimum number of trial days required to accurately predict SCS trial success. The secondary objective is to evaluate the association between SCS trial outcomes and patient-reported outcome measures, including PROMIS domain scores and candidacy recommendations generated by the SCS E-Health Tool, to assess their ability to predict SCS candidacy and treatment outcomes.
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
- •Adults aged 18 years or older who are able to provide informed consent.
- •Individuals with a clinical diagnosis of a chronic pain condition deemed appropriate for spinal cord stimulation (SCS) therapy by the treating physician.
- •Individuals with a documented duration of chronic pain greater than 12 weeks.
- •Individuals scheduled to undergo a spinal cord stimulation trial as part of routine clinical care at a participating site.
排除标准
- •Pregnant individuals.
- •Individuals currently receiving or involved in a worker's compensation claim related to their pain condition.
- •Individuals with a history of a previously failed spinal cord stimulation (SCS) trial.
- •Individuals with chronic opioid use exceeding 50 morphine milligram equivalents (MME) per day.
结局指标
主要结局
Determination of the Minimum SCS Trial Duration Predictive of Clinical Outcomes
时间窗: 15 days
Determining the minimum number of days required to accurately predict SCS trial outcomes.
次要结局
- Correlation Between Baseline PROMIS Domain T-Scores and Final SCS Trial Outcome(15 days)
- Correlation Between Baseline SCS E-Health Tool Candidacy Recommendation and Final SCS Trial Outcome(15 days)