Effectiveness of Radial Extracorporeal Shockwave Therapy in Patients With Chronic Low Back Pain - Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- change in Numeric Rating Scale (NRS)
研究概览
简要总结
Analysis of the effectiveness of radial shock wave therapy as part of a multimodal pain therapy in the inpatient setting. Different therapy protocols are compared in previously non-operated and in previously operated patients.
详细描述
Radial shock wave therapy is an approved pain therapy procedure that has been used in various degenerative orthopedic diseases for years. There are a few studies on the subject of chronic back pain. Some studies suggest that this method can be used sensibly. A direct comparison of different therapy protocols has not been carried out so far.
As part of inpatient multimodal pain therapy (including infiltration and physiotherapy) in patients with chronic lumbar back pain with or without degenerative surgery in the area of the lumbar spine radial shock wave therapy after a specific protocol is used. Only inpatients will be admitted to the study. All patients are informed verbally and give their written consent. Comprehensive patient information will be provided before the start of the study, handed out and explained as part of the information discussion. There will be 2 groups ((a) patients with previous degenerative surgery in the area of the lumbar spine, (b) patients without such a pre-operation) examined each with 4 sub-groups depending of the different therapy protocols.
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 (Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •chronic lumbar back pain of min 3 months duration
排除标准
- •radicular pain of higher intensity than chronic low back pain (cLBP)
- •new neurologic deficits
- •anticoagulant therapy
- •new trauma to the lumbar spine
- •spine bacterial infection
- •spine tumor
- •pregnancy
- •coagulation disorder
- •previous infiltration to the lumbar spine within 6 weeks prior to study inclusion
- •fibromyalgia
结局指标
主要结局
change in Numeric Rating Scale (NRS)
时间窗: pre-intervention, 2 weeks, 1 month, 3 months, 6 months
Pain intensity measured by Numeric Rating Scale (NRS) \- 11-point scale / min. 0 (better outcome) / max. 10 (worse outcome)
次要结局
- change in Oswestry Disability Index (ODI)(pre-intervention, 2 weeks, 1 month, 3 months, 6 months)
- change in Patient Health Questionnaire-9 (PHQ-9)(pre-intervention, 2 weeks, 1 month, 3 months, 6 months)
- change in Perseverative Thinking Questionnaire (PTQ)(pre-intervention, 2 weeks, 1 month, 3 months, 6 months)
- change in Patient Specific Functional Scale (PSFS)(pre-intervention, 2 weeks, 1 month, 3 months, 6 months)
- change in Questionnaire Subgroups for Targeted Treatment (STarT-G)(pre-intervention, 2 weeks, 1 month, 3 months, 6 months)
- change in European Quality of Life 5 Dimensions (EQ5D)(pre-intervention, 2 weeks, 1 month, 3 months, 6 months)
- change in Pain Self-Efficacy Questionnaire (PSEQ)(pre-intervention, 2 weeks, 1 month, 3 months, 6 months)
- change in The World Health Organisation- Five Well-Being Index (WHO-5)(pre-intervention, 2 weeks, 1 month, 3 months, 6 months)
- change in Big Five Inventory-SocioOeconomicPanel (BFI-S)(pre-intervention, 2 weeks, 1 month, 3 months, 6 months)
研究者
Dr. med. Tobias Lange, MBA
Principal Investigator
Ruhr University of Bochum