Contrasting Lead Migration During Spinal Stimulation Trial Period Against Therapeutic Response - Evaluating Securement Methods During the Trial Period
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Lead position changes (migration)
研究概览
简要总结
The goal of this clinical trial is to compare lead migration distance and therapeutic response for participants receiving a spinal cord stimulator during the trial period. Of note- scs trial period is a procedure name, not to be confused with this clinical trial study.
The main question[s] it aims to answer are:
- Is there a difference in migration distance and/or rate for those with external leads secured by an anchor device versus and anchor device with suture?
- How does participant activity levels during the trial period compare to migration rates? ° Does the temperature, heat index, and humidity during the trial period impact migration rates? Participants will come in for the scs trial procedure as normal. They will be asked to complete an activity survey upon return to the clinic for lead pull after the scs trial. They will also have an additional image upon return to the clinic to document lead position prior to lead pull.
Researchers will compare two groups- those with securement via anchor and those with securement via anchor and suture to see if there is an impact on therapeutic effect (percentage of pain relief) form the scs trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •Adults ages 18 and over without a failed spinal stimulation trial or implant will be accepted into the study. Patients must have a diagnosis of chronic back pain and must be patients of the identified anesthesiologists and have their procedures performed at AUHS pain clinic.
排除标准
- •Patients will be excluded if they have a history of local anesthetic allergy (lidocaine), current skin infections at the procedure site, or a diagnosis of diaphoresis/ secondary hyperhidrosis (chronic over sweating).
结局指标
主要结局
Lead position changes (migration)
时间窗: the last day of the trial period which could be day 3 up to day 6, depending on length
final location of the SCS leads at the end of the scs trial period, as seen on imaging
Therapeutic Response
时间窗: SCS trial periods are 3-6 days at our facilty.
% of pain relief achieved by the participant during the SCS trial period
次要结局
未报告次要终点
研究者
Stephanie Jones
Principal Investigator
Augusta University