Precise Management System (PreMaSy) of Chronic Intractable Pain Based on a Remote and Wireless Spinal Cord Stimulation System
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Health Condition and Life Quality: Change From Baseline in five-level EuroQol five-dimensional questionnaire (EQ-5D-5L) utility values at Month 1
研究概览
简要总结
The goal of this clinical trial is to learn about a new management system in chronic and stubborn pain patients who accept therapy of spinal cord stimulation (SCS). Usually, these patients are required to take long-term follow-ups to ensure that the stimulator works well. The main questions it aims to answer are:
- Is it better to improve the patient's quality of life than the current conventional follow-up?
- Is it better to relieve pain in the long term than the current conventional follow-up?
- Is it possible to be applied to a large population of chronic pain patients? Participants will be randomly assigned to either a control group or an interventional group.
Participants in the control group will be given the standard SCS implantation surgery and asked to complete the conventional follow-up (at least 1-, 3-, and 6-month post-operative).
Participants in the interventional group will be given the standard SCS implantation surgery and asked to do the following things:
- Take the daily pain self-assessment questions on a mobile phone APP.
- Take the monthly healthy status self-assessment questionnaires on a mobile phone APP.
- Take the conventional follow-up (at least 1-, 3-, and 6-month post-operative). Researchers will compare the two groups to see if the life quality of the interventional group is improved.
详细描述
Chronic intractable pain is a disorder with complicated causes. The patient's quality of life is significantly reduced as a result of the patient's ongoing discomfort and the necessity for lengthy therapies. When patients don't respond well to medicine or other non-surgical treatments, spinal cord stimulation (SCS) is one of the surgical methods employed. The safety and effectiveness of SCS have previously been confirmed in numerous trials as a well-researched and clinically used therapy. However, the adjustment of SCS is complicated and its optimal effect relies on long-term regular follow-up. With the development of the internet, the investigators put forward a new system with remote and wireless SCS devices. Together with an exclusively developed mobile phone application, patients will be able to record their daily pain state and monthly health condition and make customized stimulation settings accordingly. This study is aimed to test the feasibility of this new precise management system. All participants will be randomly assigned to either interventional or control group. Participants in control group will be asked to take the conventional follow-up. Participants in interventional group will be additionally asked to take self-assessment on daily pain state and monthly health condition. The investigators hypothesized that this self-involved, closely monitored, and precisely adjusted system can significantly improve patients' quality of life in the long term and cut down both the financial expenses and time cost.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •Have been clinically diagnosed with chronic, intractable pain for more than three months.
- •At enrollment, the average pain intensity is no least than 5 out of 10 cm on visual analogue scale.
- •At enrollment, the age is no younger than 18-year-old.
- •Ineffective or unsatisfactory conservative treatments, including but limited to: oral medication, nerve block, epidural corticosteroids, physical and psychological rehabilitation therapy, and chiropractic care.
- •Voluntary to take the trial and sign the informed consent.
- •Good compliance and ability to complete post-operative follow-ups.
- •Basic ability to read and use a mobile phone or having a caregiver who can.
排除标准
- •Bleeding complications or coagulation disorders.
- •Mental or cognitive disorders leading to inability to complete implantation surgery or post-operative follow-up.
- •Issues with spinal cord or vertebrates that are not suitable for implantation surgery.
- •Systemic active infections or local infections around the surgery area.
- •Pregnancy, breast-feeding, plan to be pregnant or unwilling to use contraceptive methods.
- •Metastatic malignant tumors or untreated malignant tumors.
- •Life expectancy of less than one year.
- •Already provided with a medication pump and/or other implanted devices.
- •Need for therapy or examination that must not have an implanted pulse generator (IPG), such as magnetic resonance imaging (MRI) and thermo-therapy.
- •Heavily addicted to alcohol or drugs.
- •VAS improvement less than 50% or stimulation intolerance during the test period.
- •Unable to complete long-term online follow-ups because of hardware issues such as internet, mobile phones, and so on.
- •Unwilling to participate.
- •Other inappropriate situations determined by the investigators.
研究组 & 干预措施
Precise management
Participants will be asked to take daily pain state and monthly health condition assessments.
A warning for the physicians will be given when participants reach daily assessment threshold. Remote interventional meeting will be scheduled and stimulation parameters will be adjusted accordingly.
Participants will also be asked to take conventional follow-up at 1-, 3-, and 6-month post-operative.
干预措施: Precise management (Other)
Conventional management
Participants will be only asked to take conventional follow-ups at 1-, 3-, and 6-month post-operative. During these follow-ups, they will be asked to score VAS based on general pain state, and take questionnaires including EQ-5D-5L, PSQI, PGIC, CGI-I.
结局指标
主要结局
Health Condition and Life Quality: Change From Baseline in five-level EuroQol five-dimensional questionnaire (EQ-5D-5L) utility values at Month 1
时间窗: Baseline and Month 1
Participants' health condition and life quality are measured by EQ-5D-5L utility values. EQ-5D-5L utility value has a minimum of 0 and a maximum of 1. Higher values mean a better health condition.
Health Condition and Life Quality: Change From Baseline in five-level EuroQol five-dimensional questionnaire (EQ-5D-5L) utility values at Month 3
时间窗: Baseline and Month 3
Participants' health condition and life quality are measured by EQ-5D-5L utility values. EQ-5D-5L utility value has a minimum of 0 and a maximum of 1. Higher values mean a better health condition.
Health Condition and Life Quality: Change From Baseline in five-level EuroQol five-dimensional questionnaire (EQ-5D-5L) utility values at Month 6
时间窗: Baseline and Month 6
Participants' health condition and life quality are measured by EQ-5D-5L utility values. EQ-5D-5L utility value has a minimum of 0 and a maximum of 1. Higher values mean a better health condition.
次要结局
- Sleep Quality: Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) at Month 1(Baseline and Month 1)
- Health condition: Change From Baseline in EuroQol Visual Analogue Scale (EQ VAS) at Month 3(Baseline and Month 3)
- Global impression: Change From Baseline in Patient's Global Impression of Change (PGIC) at Month 6(Baseline and Month 6)
- Pain Intensity: Change From Baseline in Visual Analogue Scale (VAS) at Month 6(Baseline and Month 6)
- Pain Time: Change From Baseline in Time-Intensity Curve at Month 1(Baseline and Month 1)
- Pain Time: Change From Baseline in Time-Intensity Curve at Month 6(Baseline and Month 6)
- Pain Location: Change From Baseline in Pain Map at Month 3(Baseline and Month 3)
- Global impression: Change From Baseline in Clinical Global Impressions-Improvement (CGI-I) at Month 1(Baseline and Month 1)
- Health condition: Change From Baseline in EuroQol Visual Analogue Scale (EQ VAS) at Month 1(Baseline and Month 1)
- Global impression: Change From Baseline in Clinical Global Impressions-Improvement (CGI-I) at Month 3(Baseline and Month 3)
- Pain Location: Change From Baseline in Pain Map at Month 6(Baseline and Month 6)
- Global impression: Change From Baseline in Clinical Global Impressions-Improvement (CGI-I) at Month 6(Baseline and Month 6)
- Health condition: Change From Baseline in EuroQol Visual Analogue Scale (EQ VAS) at Month 6(Baseline and Month 6)
- Sleep Quality: Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) at Month 6(Baseline and Month 6)
- Pain Time: Change From Baseline in Time-Intensity Curve at Month 3(Baseline and Month 3)
- Pain Location: Change From Baseline in Pain Map at Month 1(Baseline and Month 1)
- Sleep Quality: Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) at Month 3(Baseline and Month 3)
- Global impression: Change From Baseline in Patient's Global Impression of Change (PGIC) at Month 1(Baseline and Month 1)
- Global impression: Change From Baseline in Patient's Global Impression of Change (PGIC) at Month 3(Baseline and Month 3)
- Pain Intensity: Change From Baseline in Visual Analogue Scale (VAS) at Month 1(Baseline and Month 1)
- Pain Intensity: Change From Baseline in Visual Analogue Scale (VAS) at Month 3(Baseline and Month 3)
研究者
Guihuai Wang
Director of Neurocenter of Beijing Tsinghua Changgung Hospital
Beijing Tsinghua Chang Gung Hospital