NCT05068011招募中不适用
Differential Target Multiplexed Spinal Cord Stimulation: a Multicenter Cohort Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 14
- 主要终点
- Overall pain intensity with Visual Analogue Scale (VAS)
研究概览
简要总结
Evaluation of the effectiveness of differential target multiplexed spinal cord stimulation for treatment of chronic back and leg pain. Additionally, a subgroup analysis will be performed to evaluate potential differences between paddle/surgical leads versus percutaneous leads.
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
- •Patients with severe chronic pain (> 5 on numeric rating scale, NRS) for at least 6 months due to FBSS (PSPS T2) and suitable for treatment with DTM SCS according to the treating physician
- •Age > 18 years
- •Patient has been informed of the study procedures and has given written informed consent
- •Patient willing to comply with study protocol including attending the study visits
排除标准
- •Expected inability of the patient to receive or properly operate the spinal cord stimulation system
- •History of coagulation disorder, lupus erythematosus, diabetic neuropathy, rheumatoid arthritis, or morbus Bechterew
- •Active malignancy
- •Addiction to drugs, alcohol (>5 units per day) and/or medication
- •Evidence of an active disruptive psychiatric disorder or other known condition that may impact perception of pain, compliance to the intervention, and/or ability to evaluate treatment outcome as determined by investigator
- •Immune deficiency (e.g. HIV positive, immunosuppressive treatment)
- •Life expectancy < 1 year
- •Local infection or any other skin disorder at site of incision
- •Pregnancy
- •Other implanted active medical device
结局指标
主要结局
Overall pain intensity with Visual Analogue Scale (VAS)
时间窗: The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months
Overall pain, defined as a combination of back and leg pain, but not pain from other body parts, measured with the VAS (100mm)
次要结局
- Clinical holistic responder status(The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months)
- Pain catastrophizing(The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months)
- Symptoms of central sensitisation.(The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months)
- (Serious) adverse events(Throughout study period)
- Proportion of successful DTM trials.(Evaluated after final SCS implantation)
- Patient expectations concerning SCS(Evaluated at baseline visit)
- Pain medication use(The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months)
- Patient global impression of change(Evaluated at 1 month, 6 months and 12 months of DTM SCS.)
- Back pain intensity with Visual Analogue Scale (VAS)(The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months)
- Health related quality of life(The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months)
- Patients' individual competencies for self-management(The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months)
- DTM SCS stimulation parameters(Registration at 1 month, 6 months and 12 months of DTM SCS)
- Leg pain intensity with Visual Analogue Scale (VAS)(The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months)
- Functional disability(The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months)
- Work status(The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months)
- Anxiety and Depression.(The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months)
- Time spent in body postures(The data will be extracted from SCS implantation up to 1 month of SCS, from 1 month of SCS up to 6 months and from 6 months up to 12 months)
- Battery consumption(Registration at 1 month, 6 months and 12 months of DTM SCS)
- Healthcare utilisation.(The change between implantation and evaluation at 1 month, 6 months and 12 months of DTM SCS)
- Prevalence of technical issues with regard to DTM SCS programming(Throughout study period)
研究者
Moens Maarten
principal investigator
Universitair Ziekenhuis Brussel
研究点 (14)
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