Intensity Matters: Therapist-dependent Dose of Spinal Transcutaneous Electrical Nerve Stimulation
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Baseline Current Density
研究概览
简要总结
The intensity used during transcutaneous electrical nerve stimulation (TENS) in both, clinical practice and research studies, is often based on subjective commands such as "strong but comfortable sensation". There is not consensus regarding the effectiveness dose of TENS
详细描述
Twenty healthy volunteers will divide into two groups: Therapist 1 and Therapist 2. Both therapist will apply spinal TENS and sham stimulation for 40min in random order to each subject, at an intensity to produce a "strong but comfortable sensation".
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 (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers between 18 and 60 years old
排除标准
- •Musculoskeletal pathology of the lower limbs
- •History of neuromuscular disease
- •Unable to tolerate electrical current
- •Allergy to the electrode material
- •Pacemaker or any implanted device
- •Neurotrauma
- •Recent surgical procedures
- •Pain affecting the lower limbs or lower back
- •Pregnancy
结局指标
主要结局
Baseline Current Density
时间窗: At the onset (0min) of the Spinal TENS session
Current density (mA/cm2) is obtained by a mathematical operation which reflects the applied current intensity divided by the electrode area (45cm2)
Final Current Density
时间窗: At the end (40min) of the Spinal TENS session
Current density (mA/cm2) is obtained by a mathematical operation which reflects the applied current intensity divided by the electrode area (45cm2)
次要结局
- Baseline Maximal peak-to-peak soleus H-reflex(baseline at 0min)
- Baseline Maximal peak-to-peak soleus M wave(baseline at 0min)
- Baseline Normalized H-reflex response(baseline at 0min)
- During Maximal peak-to-peak soleus M wave(during treatment at 33min)
- During Normalized H-reflex response(during treatment at 33min)
- During Maximal peak-to-peak soleus H-reflex(during treatment at 33min)
- Post-treatment Maximal peak-to-peak soleus H-reflex(Immediately after treatment at 40 min)
- Post-treatment Maximal peak-to-peak soleus M wave(Immediately after treatment at 40 min)
- Post-treatment Normalized H-reflex responseMaximal peak-to-peak soleus H-reflex(Immediately after treatment at 40 min)