Peripherical Neuromuscular Electrical Stimulation in Systemic Autoimmune Myopathies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Frequency of treatment-emergent adverse events [safety and tolerability]
研究概览
简要总结
Systemic autoimmune myopathies are a heterogeneous group of rheumatic diseases with progressive skeletal muscle weakness. The relevance of the peripherical neuromuscular electrical stimulation has never applied in the patients with systemic autoimmune myopathies. Therefore, the main objective of the present prospective, randomized, investigator-blind, placebo-controlled study is to evaluate the safety and efficacy of the application of an acute peripherical neuromuscular electrical stimulation session in patients with systemic autoimmune myopathies.
详细描述
Systemic autoimmune myopathies are a heterogeneous group of rheumatic diseases that primarily affect the skeletal muscles. Despite these advances, this group of diseases still continues to be associated with high morbidity and functional disability, mainly due to the proximal muscular weakness of the scapular and pelvic girdles that may prevent the total recovery of these patients. On the other hand, the importance of the peripherical neuromuscular electrical stimulation has never applied in the patients with systemic autoimmune myopathies. Therefore, the main objective of the present prospective, randomized, investigator-blind, placebo-controlled study is to evaluate the safety and efficacy of the application of an acute peripherical neuromuscular electrical stimulation session in patients with systemic autoimmune myopathies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Investigator)
盲法说明
Patients will be randomized by non-investigator from the present study
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
- •Classification criteria - EULAR/ACR 2017
- •Classification criteria - Connors et al.
- •Objective muscle limb weakness
排除标准
- •Neoplasia
- •Using heart pacemarker
- •Using visceral metalic clips
- •Infections (HIV, HTLV-1, Hepatitis, etc)
- •Pregnancy
- •Previous historical of convulsions or epilepsies
结局指标
主要结局
Frequency of treatment-emergent adverse events [safety and tolerability]
时间窗: 8 weeks after stimulation
Frequency of disease relapsing (based on the questionnaire of secondary outcome
次要结局
- Patient/Parent Global Activity(4 times: (a) within 30 minutes before; (b) until 30 minutes after stimulation. Then, after (c) 3 weeks and (d) 8 weeks after stimulation)
- Serum levels of muscle enzymes(4 times: (a) within 30 min before; (b) until 30 min after stimulation. Then, after (c) 3 weeks and (d) 8 weeks after stimulation)
- Healthy Assessment Questionnaire (HAQ)(3 times: (a) within 30 minutes before stimulation. Then, after (b) 3 weeks and (c) 8 weeks after stimulation)
- Myositis Disease Activity Assessment Visual Analogue Scales (MYOACT)(3 times: (a) within 30 minutes before stimulation. Then, after (b) 3 weeks and (c) 8 weeks after stimulation)
- Physician Global Activity(4 times: (a) within 30 minutes before; (b) until 30 minutes after stimulation. Then, after (c) 3 weeks and (d) 8 weeks after stimulation)
- Manual Muscle Testing(4 times: (a) within 30 minutes before; (b) until 30 minutes after stimulation. Then, after (c) 3 weeks and (d) 8 weeks after stimulation)
- Strength muscle tests(4 times: (a) within 30 minutes before; (b) until 30 minutes after stimulation. Then, after (c) 3 weeks and (d) 8 weeks after stimulation)
研究者
Samuel Katsuyuki Shinjo, PhD
Professor, PhD
University of Sao Paulo