Epley 手法治疗多发性硬化症患者后半规管良性阵发性位置性眩晕的随机对照试验方案。
Epley manoeuvre for posterior semicircular canal benign paroxysmal positional vertigo in people with multiple sclerosis: protocol of a randomised controlled trial.
机构信息
Department of Physiotherapy, University of Seville, Sevilla, Spain.
Department of Physiotherapy, University of Seville, Sevilla, Spain
出版信息
BMJ Open. 2021 Mar 18;11(3):e046510. doi: 10.1136/bmjopen-2020-046510.
INTRODUCTION
Vestibular disorders in multiple sclerosis (MS) could have central or peripheral origin. Although the central aetiology is the most expected in MS, peripheral damage is also significant in this disease. The most prevalent effect of vestibular peripheral damage is benign paroxysmal positional vertigo (BPPV). Impairments of the posterior semicircular canals represent 60%-90% of cases of BPPV. The standard gold treatment for this syndrome is the Epley manoeuvre (EM), the effectiveness of which has been poorly studied in patients with MS. Only one retrospective research study and a case study have reported encouraging results for EM with regard to resolution of posterior semicircular canal BPPV. The aim of this future randomised controlled trial (RCT) is to assess the effectiveness of EM for BPPV in participants with MS compared with a sham manoeuvre.
METHODS AND ANALYSIS
The current protocol describes an RCT with two-arm, parallel-group design. Randomisation, concealed allocation and double-blinding will be conducted to reduce possible bias. Participants and evaluators will be blinded to group allocation. At least 80 participants who meet all eligibility criteria will be recruited. Participants will have the EM or sham manoeuvre performed within the experimental or control group, respectively. The primary outcome of the study is changes in the Dix Hallpike test. The secondary outcome will be changes in self-perceived scales: Dizziness Handicap Inventory and Vestibular Disorders Activities of Daily Living Scale. The sample will be evaluated at baseline, immediately after the intervention and 48 hours postintervention.
ETHICS AND DISSEMINATION
The study was approved by the Andalusian Review Board and Ethics Committee of Virgen Macarena-Virgen del Rocio Hospitals (ID 0107-N-20, 23 July 2020). The results of the research will be disseminated by the investigators to peer-reviewed journals.
TRIAL REGISTRATION NUMBER
NCT04578262.
简介
多发性硬化症（MS）中的前庭障碍可能具有中枢或外周起源。尽管中枢病因在 MS 中最为常见，但外周损伤在这种疾病中也很重要。前庭外周损伤最常见的影响是良性阵发性位置性眩晕（BPPV）。后半规管损害占 BPPV 病例的 60%-90%。该综合征的标准黄金治疗方法是 Epley 手法（EM），但其在 MS 患者中的疗效研究甚少。仅有一项回顾性研究和一项病例研究报告了 EM 在后半规管 BPPV 中的令人鼓舞的结果。本未来随机对照试验（RCT）的目的是评估 EM 治疗 MS 患者 BPPV 的效果与假手法相比。
方法与分析
本方案描述了一项具有双臂、平行组设计的 RCT。将采用随机化、隐藏分配和双盲法来减少可能的偏差。参与者和评估者将对分组分配保持盲态。将招募至少 80 名符合所有入选标准的参与者。参与者将分别在实验组或对照组中接受 EM 或假手法治疗。该研究的主要结局是 Dix-Hallpike 试验的变化。次要结局将是自我感知量表的变化：头晕障碍量表和前庭障碍日常生活活动量表。样本将在基线、干预后即刻和干预后 48 小时进行评估。
伦理与传播
该研究已获得安达卢西亚审查委员会和 Virgen Macarena-Virgen del Rocio 医院伦理委员会的批准（ID 0107-N-20，2020 年 7 月 23 日）。研究结果将由研究人员传播至同行评议期刊。
试验注册号
NCT04578262。
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