Neuronavigated Repetitive Transcranial Magnetic Stimulation (nrTMS) of the Dorsolateral Prefrontal and Primary Motor Cor-tex for the Treatment of Chronic Pain: a Randomized Place-bo-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Numeric Rating Scale
研究概览
简要总结
This study investigated the effects of navigated repetitive Transcranial Magnetic Stimulation on nociception and quality of life in patients suffering from chronic pain conditions. Two cortical targets (dorsolateral prefrontal cortex/DLPFC and M1 area) were stimulated and compared to Sham stimulation.
详细描述
From 34 patients, 24 completed the study. The M1-area was stimulated with 10 Hz rTMS while the DLPFC received a 5Hz stimulation. In total, 13 session were administered over a period of 36 weeks with most frequent stimulation in the first 4 weeks of the trial. Results were compared to Sham-TMS over the M1 area at the same schedule than the actual therapy. Outcome parameters included the German Pain Questionnaire (GPQ), the Depression, Anxiety and Stress Scale" (DASS) and quality of life (QoL) with the SF-12 questionnaire.
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 (Participant)
盲法说明
Sham stimulation was provided by turning the TMS coil to the non-stimulating side.
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
- •age between 18 and 80 years
- •clinical diagnosis of chronic LBP (low back pain) and or neck pain
- •average resting pain-level > than 3 in the Numeric Rating Scale (0-10)
- •no changes in pain medication 4 weeks at baseline
- •no surgical procedures in the last 2 years
排除标准
- •metallic and electronic implants in the head, neck and chest
- •medication e.g. tetracyclic antidepressants, antiviral, antipsychotic, opioid doses > 100mg orally/d
- •history of frequent headache or tinnitus
- •alcohol or drug abuse
- •pregnant patients
- •breastfeeding patients
结局指标
主要结局
Numeric Rating Scale
时间窗: 36 weeks
0-10 0 = no pain, 10 = worst pain
次要结局
- Self-reported "Depression, Anxiety and Stress Scale" (DASS) questionnaire.(36 weeks)