Loyo Myriam, McReynold Margaret, Mace Jess C, Cameron Michelle
Department of Otolaryngology - Head and Neck Surgery, Oregon Health & Science University, Portland, OR, USA.
Department of Rehabilitation, Oregon Health & Science University, Portland, OR, USA.
J Rehabil Assist Technol Eng. 2020 Dec 10;7:2055668320964142. doi: 10.1177/2055668320964142. eCollection 2020 Jan-Dec.
Electric stimulation (ES) can prevent muscle atrophy and promote tissue healing and therefore may help prevent sequelae of Bell's palsy but due to lack of high-quality studies, the effectiveness of ES in Bell's palsy remains controversial. Here we describe a protocol to evaluate the effects of monophasic high volt ES in patients with Bell's palsy and poor prognosis for recovery.
This is a protocol for a prospective, double-blinded, randomized, placebo-controlled study. Participants include adults with acute Bell's palsy with poor prognosis for full recovery due to complete paralysis or being over age 60. ES will be a monophasic, high-volt pulsed waveform, 100μsec pulse duration, 35 hertz, motor-level intensity. Follow up will be at months 1, 2, 3 and 6. The primary outcome will be the proportion of patients with complete recovery using the eFACES tool. Secondary outcomes include patient reported quality of life measured by FaCE and the synkinesis assessment questionnaires, objective photographs, time to complete recovery, adverse effects, and tolerability.
This protocol has the potential to provide high quality evidence regarding the effects, up to 6 months after onset, of pulsed monophasic high-volt ES for patients with acute Bell's palsy and poor prognosis for complete recovery.
电刺激（ES）可预防肌肉萎缩并促进组织愈合，因此可能有助于预防贝尔麻痹的后遗症，但由于缺乏高质量研究，ES在贝尔麻痹中的有效性仍存在争议。在此，我们描述了一项评估单相高压ES对贝尔麻痹且恢复预后较差患者疗效的方案。
这是一项前瞻性、双盲、随机、安慰剂对照研究的方案。参与者包括因完全性麻痹或年龄超过60岁而完全恢复预后较差的急性贝尔麻痹成人患者。ES将采用单相、高压脉冲波形，脉冲持续时间100微秒，频率35赫兹，运动水平强度。随访时间为第1、2、3和6个月。主要结局将是使用eFACES工具完全恢复的患者比例。次要结局包括通过FaCE和联带运动评估问卷测量的患者报告的生活质量、客观照片、完全恢复时间、不良反应和耐受性。
该方案有可能为急性贝尔麻痹且完全恢复预后较差的患者提供关于发病后长达6个月的脉冲单相高压ES疗效的高质量证据。
