NCT07211308招募中不适用
Open and Closed Loop Differential Target Multiplexed Spinal Cord Stimulation in Patients With Persistent Spinal Pain Syndrome Type II: a European Multicenter Cohort Study (ENDLESS)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 5
- 主要终点
- Overall pain intensity
研究概览
简要总结
Evaluation of the effectiveness of differential target multiplexed spinal cord stimulation for treatment of Persistent Spinal Pain Syndrome Type II (PSPS-T2). Identification of clinical effective parameters concerning frequency, pulse duration, amplitude and battery consumption/recharge frequency and safety evaluation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •having chronic pain as a result of PSPS-T2 that exists for at least 6 months with at least moderate pain intensity (4 or higher measured on numeric rating scale (NRS) or 31mm or higher measured on visual analogue scale (VAS) for the dominant pain location.
- •being offered treatment with DTM SCS
- •being at least 18 years old
排除标准
- •Expected inability of patients to properly operate the SCS system
- •History of coagulation disorders, lupus erythematosus, diabetic neuropathy
- •Active malignancy
- •Addiction to drugs and/or alcohol (more than 5 units /day)
- •Evidence of an active disruptive psychiatric disorder or other known condition significant enough to impact perception of pain, compliance to intervention and/or ability to complete questionnaires, as determined by the investigator
- •Immune deficiency (e.g. HIV positive, immunosuppressiva)
- •Life expectancy < 1 year
- •Local infection or other skin disorder at site of incision
- •Pregnancy
- •Other implanted active medical device
结局指标
主要结局
Overall pain intensity
时间窗: The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months
The primary effectiveness outcome measure is pain intensity measured with the Visual Analogue Scale (VAS), ranging from 0 (no pain) to 100 (maximal pain) in electronic format. Two scales will be presented for low back/neck pain and for leg/arm pain. Ecological momentary Assessment (EMA) will be used to collect pain intensity scores for VAS, whereby pain intensity is measured for multiple times per day for 1 week to reveal patterns of transient or fluctuating symptoms in the environment and context of the patients' lives, without a recall bias.
次要结局
- Pain intensity for the lower back and leg pain or neck and arm pain component(The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months)
- Medication use(The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months)
- Negative affect(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)
- Health related quality of life(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)
- Clinical holistic responder status(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)
- Pain catastrophizing(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)
- Patient expectations concerning SCS(Evaluated at baseline visit)
- Patient unwanted stimulation awareness and satisfaction about the therapy(Evaluated at 1 month, 6 months and 12 months of DTM SCS)
- 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)
- (Serious) adverse events(Throughout study period, an average of 1 year)
- Proportion of successful DTM trials(Evaluated after final SCS implantation)
- Technical IPG details (ECAPs etc.)(Registration at 1 month, 6 months and 12 months of DTM SCS)
- DTM SCS stimulation parameters(Time Frame: Registration at 1 month, 6 months and 12 months of DTM SCS)
- Battery consumption(Registration at 1 month, 6 months and 12 months of DTM SCS)
- Prevalence of technical issues with regard to DTM SCS programming(Throughout study period, an average of 1 year)
- Actigraphy data(The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months)
研究者
研究点 (5)
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