The Holistic Response of Patients With Persistent Spinal Pain Syndrome Type II by Subthreshold Spinal Cord Stimulation Compared to Best Medical Treatment, Investigated by a Multicentric Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 114
- 试验地点
- 6
- 主要终点
- Clinical holistic responder status
研究概览
简要总结
Given the substantial socioeconomic impact of Spinal Cord Stimulation (SCS) implantations and given that currently no direct high-quality evidence with a relevant outcome measurement is available to guide the treatment choice between subthreshold SCS versus best medical treatment in patients with Persistent Spinal Pain Syndrome Type 2 (PSPS-T2), we here propose a scientifically well-constructed randomized controlled trial to answer this question.
The primary scientific objective is to examine whether subthreshold SCS, compared to best medical treatment, provided to patients with PSPS-T2 results in a higher percentage of clinical holistic responders at 6 months. The secondary objective of the study is to examine if subthreshold SCS compared with BMT is having more efficacy in improving patients' individual competencies for self-management, increasing the likelihood to return to work, work status and healthcare expenditure, improving pain relief, obtaining pain medication reduction, decreasing anxiety and depression, increasing quality of life and decreasing disability.
详细描述
After filling in the questionnaires at the 6 months follow-up visit, patients could change treatment groups (in both directions). This decision will be a shared decisions between patient and treating physician in case the randomized intervention did not provided enough pain relief.
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
- Single (Outcomes Assessor)
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
- •Persistent Spinal Pain Syndrome Type II (PSPS-T2)
- •Chronic pain as a result of PSPS-T2 that exists for at least 6 months with a pain intensity of at least 4/10 on the Numeric Rating Scale, refractory to conservative treatment.
- •PSPS-T2 patients eligible for subthreshold SCS
- •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 patients to receive or properly operate the spinal cord stimulation system
- •Evidence of an active psychiatric disorder
- •Suffering from another chronic illness characterised by chronic generalized widespread pain (e.g. rheumatoid arthritis, fibromyalgia, chronic fatigue syndrome, scleroderma).
- •Pregnancy
结局指标
主要结局
Clinical holistic responder status
时间窗: The change between the baseline screening and the evaluation at 1 month, 6 months and 12 months.
The clinical holistic responder status as a composite measure represents the global effect of a treatment, based on a combination of questionnaires.
次要结局
- Overall pain intensity with Visual Analogue Scale (VAS)(The change between the baseline screening and the evaluation at 1 month, 6 months and 12 months.)
- Work status(The change between the baseline screening and the evaluation at 1 month, 6 months and 12 months.)
- Patients' individual competencies for self-management(The change between the baseline screening and the evaluation at 1 month, 6 months and 12 months.)
- Pain medication use(The change between the baseline screening and the evaluation at 1 month, 6 months and 12 months.)
- Functional disability(The change between the baseline screening and the evaluation at 1 month, 6 months and 12 months.)
- Health related quality of life(The change between the baseline screening and the evaluation at 1 month, 6 months and 12 months.)
- Healthcare utilisation.(The change between the baseline screening and the evaluation at 1 month, 6 months and 12 months.)
- Patient global impression of change(Evaluated at 1 month, 6 months and 12 months.)
- Anxiety and Depression.(The change between the baseline screening and the evaluation at 1 month, 6 months and 12 months.)
研究者
Moens Maarten
principal investigator
Universitair Ziekenhuis Brussel