External Sensing and Neuromodulation to Assess Diabetic Pain Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- The mean change in pain scores measured by the Numerical Rating Scale (NRS) at baseline and follow up at 3 months
研究概览
简要总结
This is a prospective, longitudinal, single-center, non-randomized, open-label, post-market clinical feasibility study to assess the efficacy of neuromodulation therapies (SCS and DRG) for chronic pain patients with diabetes and investigate whether physical and physiological data collected from diabetic and pre-diabetic chronic pain patients is predictive of subjective patient-reported outcomes (PROs) and of adjustments in patient care. These assessments will be made prior to, during, and after the trial of the SCS or DRG system. The study will be carried out in the United States at a single site.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Subject must provide written informed consent prior to any clinical investigation-related procedure.
- •Subject is at least 18 years of age or older at the time of enrollment.
- •Subject's scheduled trial duration for the Abbott neuromodulation system is at least 7 days.
- •Subject is scheduled to undergo trial of an Abbott neuromodulation system for chronic intractable back and/or leg pain at least 7 days after enrollment and commencement of the baseline data collection period.
- •Subject agrees to take an A1C screening test prior to study enrollment and has a confirmed HbA1C level ≥ 5.7%.
- •Subject has a baseline (with no stimulation) pain NRS of ≥
- •Subject is willing to cooperate with the study requirements including completion of all office visits.
- •Subject agrees to wear the wearable sensing devices (Fitbit® and Freestyle Libre).
- •Subject agrees to answer questionnaires regularly for the duration of the study.
排除标准
- •Subject is enrolled, or intends to participate, in a competing or confounding clinical study, as determined by Abbott.
- •Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period.
- •Subject is part of a vulnerable population.
- •Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements of the clinical investigation results.
- •Subject has a current diagnosis of a coagulation disorder, bleeding diathesis, progressive peripheral vascular disease, post-herpetic neuralgia.
- •Subject has, or is scheduled to receive, implantation of another neuromodulation system (e.g. DRG or SCS system or intrathecal pump) to address their chronic pain.
- •Subject has already participated in a SCS trial period before enrolling in the study.
- •Subject engages in a profession or other activity that could be damaging to the wearable sensors, as determined by the investigator.
- •Subject has a physical condition that makes it difficult to wear the wearable sensors, as determined by the investigator.
- •Subject has tremors (e.g. Parkinson's disease or Familial tremors).
- •Subject has sleep/wake schedule that would present a challenge in completing all clinical site visits or in use of the wearable devices and engagement in the surveys via the mobile device.
- •Subject is bedridden.
结局指标
主要结局
The mean change in pain scores measured by the Numerical Rating Scale (NRS) at baseline and follow up at 3 months
时间窗: At 3 month
Change in pain scores measured by the NRS at baseline and follow up study visits at 3 months.
The mean change in pain scores measured by the Numerical Rating Scale (NRS) at baseline and follow up at 6 months
时间窗: At 6 month
Change in pain scores measured by the NRS at baseline and follow up study visits at 6 months.
次要结局
未报告次要终点