Efficacy of Audio-Visual-Perception-Enhancement (AVWF®) Method in Chronic Pain Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 2
- 主要终点
- Change in Numeric Rating Scale of Pain Severity
研究概览
简要总结
It is anticipated that Audio-Visual-Perception-Enhancement (AVWF®) method leads to pain reduction and a decrease of inflammatory markers in chronic pain patients. Also an improvement of quality of life, self-perceived disability and depression in chronic pain patients is expected.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •chronic low back pain with a numeric rating scale of pain >= 4 for > 6 month
- •patients >18 years
排除标准
- •psychosis
- •drug addiction
- •pension process
- •pregnant women
结局指标
主要结局
Change in Numeric Rating Scale of Pain Severity
时间窗: Change from baseline Numeric Rating Scale of Pain Severity after 10 interventions, 4 weeks after the last intervention, and 3 month after the last intervention
Validated 11 pt scale 0-10, to evaluate a patient's current severity of pain. A rating of 0 indicates no pain while 10 indicates the worst pain imaginable. A score of 4 or above is considered a clinically significant pain Level.
次要结局
- Depression Anxiety Stress Scales(Change from baseline Depression Anxiety Stress Scales after 10 interventions, 4 weeks after the last intervention, and 3 month after the last intervention)
- Hospital Anxiety and Depression Scale(Change from baseline Hospital Anxiety and Depression Scale after 10 interventions, 4 weeks after the last intervention, and 3 month after the last intervention)
- Health related quality of life(Change from baseline health related quality of life after 10 interventions, 4 weeks after the last intervention, and 3 month after the last intervention)
- Pittsburgh Sleep Quality Index(Change from baseline Pittsburgh Sleep Quality Index after 10 interventions, 4 weeks after the last intervention, and 3 month after the last intervention)
- Pain Disability Index(Change from baseline Pain Disability Index after 10 interventions, 4 weeks after the last intervention, and 3 month after the last intervention)
- Salival Cortisol level(Change from baseline salival cortisol level after 10 interventions, 4 weeks after the last intervention, and 3 month after the last intervention)
研究者
Rudolf Likar
Prim.Univ.Prof.Dr.
Klinikum Klagenfurt am Wörthersee