Efficacy of Closed-Loop Spinal Cord Stimulation for Complex Regional Pain Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Change in Target Activation Amplitude Levels by the Spinal Cord Stimulation Device
研究概览
简要总结
The primary purpose of this study is to determine the differences in response to treatment of complex regional pain syndrome with a closed-loop spinal cord stimulator if applied in the early phases (acute or subacute) versus the chronic phase.
详细描述
After being informed about the study and the potential risks, all patients given written informed consent will be organized into group 1 (acute or subacute) and group 2 (chronic). They will undergo a trial period with a temporary spinal cord stimulator for 7 days. After the trial period, if the provider determines the device improved the patient's pain and function, the permanent device will be implanted. The patient will fill out an outcomes packet at baseline, end of trial period, 3 months and 6 months. There will also be a blood draw to evaluate prolactin levels, which are associated with stress and pain, at baseline, end of trial period, and 3 months.
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
- •18 years or older
- •neuromodulation naive patients with unilateral CRPS type 1 or type 2 (defined by Budapest Criteria)
- •pre-procedure psychological clearance
排除标准
- •younger than 18 years
- •prior neuromodulation including spinal cord stimulation
- •prior dorsal root ganglion stimulation
- •prior peripheral nervous system stimulation
- •anatomical obstacles to dorsal column lead placement
结局指标
主要结局
Change in Target Activation Amplitude Levels by the Spinal Cord Stimulation Device
时间窗: 7 day trial period, 3 months, and 6 months.
Spinal cord stimulation device parameters will be collected to determine if a lower voltage is required to treat acute phase of complex regional pain syndrome as compared to later phases. This will be conducted at follow up visits and analyzed by the medical device representative. The data will be pulled and analyzed to determine the activation point for each patient. This will be captured at the 7 day trial period, 3 months, and 6 months.
Change in Complex Regional Pain Syndrome Severity Scores
时间窗: Baseline, 7 day trial period, 3 months, 6 months
(CRPS SS) This will be determined at baseline by the provider based on his diagnosis of the patient's condition, being acute and subacute or chronic. This is based on the presence or absence of 16 clinically-assessed signs and symptoms, and complements the diagnostic criteria for CRPS. A higher score indicates greater severity of the condition. This will be followed up at the 7 day trial period, 3 months and 6 months post procedure by evaluation.
次要结局
- Quality of Life Questionnaire(Baseline, 7 day trial period, 3 months, and 6 months)
- Patient Global Impression of Change(7 day trial period, 3 months and 6 months)
- Visual Analogue Pain Scale(Baseline, 7 day trial period, 3 months, and 6 months)
- Patient Health Questionnaire-9(Baseline, 7 day trial period, 3 months, 6 months)
- Short-Form McGill Pain Questionnaire-2(Baseline, 7 day trial period, 3 months, 6 months)
- Pain Catastrophizing Scale(Baseline, 7 day trial period, 3 months, 6 months)
- Amount of Pain Medication Consumed by Patient(Baseline, 7 day trial period, 3 months and 6 months)
- Change in Prolactin Levels(Baseline, 7 day trial period, and 3 months)
- Patient Reported Outcomes Measurement Information System-29 v 2.1(Baseline, 7 day trial period, 3 months, and 6 months)
- General Anxiety Disorder-7(Baseline, 7 day trial period, 3 months and 6 months.)
研究者
David Hiller, MD
Principal Investigator
Scripps Health