Clinical Assessment of Transcutaneous Neurostimulation and Biofeedback (FREMS)in Patients With Diabetic Neuropathy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Daytime and night-time pain scores assessed at baseline, after FREMS/placebo, and 4 month follow-up
研究概览
简要总结
We postulate that frequency-modulated electromagnetic stimulation (FREMS) may decrease pain in patients with painful diabetic neuropathy.
详细描述
The stuy was designed as a randomized, double-blind, placebo-controlled cross-over trial. Each patient received two series of ten treatments of either FREMS or placebo in random sequence, with each series lasting no more than three weeks. Primary outcomes (daytime and night-time pain scores) an secondary outcomes (Motor and sensory nerve conduction velocity, sensory tactile perception, foot vibration perception threshold, quality of life, cutaneous microvascular flow, partial tissue tension of oxygen and carbon dioxide) were measured at baseline, after FREMS/placebo series and after 4 months follow-up.
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
- Double
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
- •type 1 or type 2 diabetes (American Diabetes Association criteria)
- •painful diabetic neuropathy with reduced sensory/motor nerve conduction velocity (i.e., <40 m/sec in at least one nerve trunk of the lower limbs)
- •vibration perception at the big toe >25 V
排除标准
- •presence of any concomitant severe disease
- •pregnancy
- •renal disease (serum creatinine >2.0 mg/dL)
- •history or current foot ulcer
- •lower limb arterial disease (ankle-brachial index <0.9) or transcutaneous partial pressure of oxygen <50 mmHg)
结局指标
主要结局
Daytime and night-time pain scores assessed at baseline, after FREMS/placebo, and 4 month follow-up
次要结局
- Measurements of the following parameters were made at baseline, after FREMS/placebo, and 4 month follow-up:
- Motor and sensory nerve conduction velocity
- Sensory tactile perception by monofilament
- Foot vibration perception threshold by biothesiometer
- Quality of life by SF-36 instrument
- Cutaneous microvascular flow by laser doppler
- Partial tissue tension of oxygen and carbon dioxide by oxymetry