摘要
背景:中风作为一种疾病,中医早在2 000多年前即有诸多经典著作对其进行描述。然而,大部分有关针刺对中风后遗症患者功能恢复的疗效的临床对照试验未能得出针刺具有长期疗效的结论。并且,很多试验以表面肌电图测量患者骨骼肌的电活动以评定针刺刺激的即时疗效的结论也不一致。这些研究结果对针刺在神经肌肉水平的作用提出了质疑。本研究旨在比较徒手针刺影响健康人和中风后肌张力亢进患者的肱二头肌功能及力量的即时效果。方法与设计:本研究拟开展含有4个平行对照组的随机单盲临床试验。分别针刺健康受试者及中风后遗症痉挛性轻瘫患者的曲池(LI11)及天泉(PC2)2个穴位。表面肌电图测量针刺对于肌肉功能的即时疗效及肱二头肌的等长张力作为主要结局指标。次要结局指标包括每组中医证候的出现频率及频率分布。讨论:本研究的临床试验设计在方法学上较之前的类似试验有些改善。预计这一研究能够证实针刺刺激对健康人及中风后遗症患者的神经肌肉的作用。临床试验注册:巴西临床试验注册(www.ensaiosclinicos.gov.br,注册号为RBR-5g7xqh).
BACKGROUND：Stroke is a morbid entity in Chinese medicine recognized for over 2 000 years with sensory-motor impairments reported by several classical authors. However, the majority of controlled clinical trials of acupuncture in the treatment of poststroke recovery failed to obtain significant long-term results on functional recovery. Moreover, contradictory results have been obtained regarding the immediate effects of acupuncture stimulation on the electrical activity of human skeletal muscles as observed using surface electromyography. These results raise the question of whether acupuncture has any effect on the neuromuscular level. This study aims to evaluate the immediate effects of manual acupoint stimulation on the electrical activity and strength of the biceps brachii of healthy individuals and patients with chronic hypertonic hemiparesis. METHODS AND DESIGN： The study proposes a single-blinded randomized clinical trial with four parallel groups. Healthy subjects and poststroke patients with chronic spastic hemiparesis will be submitted to a single acupuncture intervention puncturing either Quchi （Llll） or Tianquan （PC2）. The immediate effects on muscle function will be assessed by surface electromyography and isometric force of the biceps brachii muscle as the primary outcome. Secondary outcomes comprise the frequency of patterns in each group, as well as the frequency distribution of manifestations. DISCUSSION： The proposed study design includes some improvements on common methodological issues on clinical trials with an integrative design. This study design is expected to provide new insights on the neuromuscular effects of acupuncture stimulation in healthy subjects and poststroke patients.TRIAL REGISTRATION： Brazilian Clinical Trials Registry （www. ensaiosclinicos, gov. br） in English and Portuguese in October 2011. Registration number. RBR-5g7xqh.
出处
《中西医结合学报》
CAS
2012年第3期303-309,共7页
Journal of Chinese Integrative Medicine
关键词
针刺疗法
中风后遗症
运动障碍
肌电描计术
随机对照试验
临床方案
acupuncture therapy
poststroke syndrome
movement disorders
electromyography
randomized controlled trials
clinical protocols
