High-tone External Muscle Stimulation for Treatment of Chronic Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Back pain
研究概览
简要总结
Sciatica is a common pain problem that affects not only the patient but also constitutes a socioeconomic burden and thus affects the whole society. So far, current pharmacologic therapies are inadequate for many patients. Therefore, we evaluated application of high-tone external muscle stimulation (HTEMS) compared to transcutaneous electrical nerve stimulation (TENS) on radicular pain associated with sciatica.
详细描述
Hospital patients (n=100) with chronic sciatica and stable oral analgesic regimen were included into this randomized controlled cross-over trial. Each intervention was administered for a period of 45 min 5 times within 10 days, with a 3-day wash-out period before cross-over. Health impairments had been assessed using the visual analog scales (VAS) for radicular pain before and after intervention and differences in radicular pain between groups were analysed with the Mann-Whitney test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •sciatica due to degenerative spine disorders
- •stable oral analgesic regimen
排除标准
- •history of drug or alcohol abuse
- •cardiac pacemaker or defibrillator
- •pregnancy
结局指标
主要结局
Back pain
时间窗: 10 days
Back pain measured by an 11-point visual analogue scale (VAS) with 0 = none and 10 = worst pain imaginable
次要结局
未报告次要终点
研究者
Stephan Martin
Principal investigator
West German Center of Diabetes and Health