Acupuncture in Symptomatic Diabetic Peripheral Neuropathy.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Visual analogue Scale (VAS) general complaints and pain
研究概览
简要总结
Multicentric,randomized, two-armed confirmatory trial on the effectiveness of acupuncture in patients with symptomatic peripheral diabetic neuropathy compared to routine care.
详细描述
The study will investigate the effect of a series of acupuncture treatments on subdimensions of neuropathic symptoms, such as pain, tingling and numbness. Neurophysiological testing of the affected nerves are incorporated into the study as a possible morphological correlate of functional and clinical findings.
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
- None
盲法说明
The statistician will be blinded to the study intervention.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
acupuncture plus routine care
12 session of semistandardized acupuncture together with pharmacological routine care
干预措施: acupuncture (Procedure)
acupuncture plus routine care
12 session of semistandardized acupuncture together with pharmacological routine care
干预措施: routine care (Drug)
routine care alone
pharmacological routine care (antidepressants, anticonvulsants, opioids, nonsteroidal antiinflammatory drugs)
干预措施: routine care (Drug)
结局指标
主要结局
Visual analogue Scale (VAS) general complaints and pain
时间窗: 8 weeks
Visual analogue Scale 100mm- ranging from 0mm no symptoms/ pain to 100mm worst imaginable symptoms or pain
次要结局
- neuropathic pain symptom inventory (NPSI )(average of last 24h at baseline, 8, 16, 24 weeks)
- -diabetic peripheral neuropathic pain Impact measure (DPNPI)(average of last week at baseline, 8, 16, 24 weeks)
- pain perception Scale (SES german)(latest average at 8, 16, 24 weeks)
- neurophysiological assessment of Nervus Suralis height of amplitude of action potential(baseline, 8,16 and 24 weeks)
- neurophysiological assessment of Nervus Suralis nerve conduction velocity(baseline, 8,16 and 24 weeks)
- Short-Form -12 (SF-12)(baseline , 8 weeks)
- Patient global impression of Change (PGIC)(8, 16 and 24 weeks)
研究者
Benno Brinkhaus
Principal Investigator
Charite University, Berlin, Germany