眼动训练联合常规物理治疗对慢性非特异性颈痛的影响：一项随机对照试验方案

文献信息

中文摘要

引言： 慢性非特异性颈痛（CNNP）是一种常见且致残性的肌肉骨骼疾病，常伴有颈椎感觉运动缺陷和自主神经系统（ANS）调节异常；虽然常规物理治疗（CPT）可以减轻疼痛和残疾，但其对自主神经功能障碍的效果往往有限。眼动训练（EME）可调动眼动-前庭-本体感觉网络并刺激迷走-副交感通路，具有潜在的协同获益。然而，支持将EME整合入CNNP康复方案的临床证据匮乏。本试验旨在评估EME+CPT与单纯CPT相比，在缓解CNNP患者疼痛强度、残疾程度、自主神经调节和生活质量方面的疗效。
方法： 一项单中心、评估者盲法的随机对照试验将招募60名CNNP病程≥12周的成人。参与者将按1:1随机分配至单纯CPT组或CPT+EME组。干预为每周3次，连续4周（每次约60分钟）。主要结局为疼痛强度（采用100 mm视觉模拟量表VAS测量）。预设主要终点为第30天，主要治疗对比为从基线至第30天VAS平均变化值的组间差异。次要结局包括颈部残疾指数、颈椎主动活动范围、焦虑和抑郁严重程度以及健康相关生活质量。心率变异性（HRV）被预设为次要机制性结局，而眼动表现、电感觉/疼痛阈值和眼动准确性为探索性结局。数据将在基线、第15天和第30天采集。主要分析将在意向性治疗原则下采用线性混合效应模型。
讨论： 本试验将阐明在标准康复框架中整合结构化EME是否较总时长相同的常规治疗带来额外的短期临床获益。探索性自主神经和眼动终点将有助于了解潜在的生理关联，而非推断直接因果关系，从而为未来大规模、长期康复试验提供信息。
临床试验注册： https://www.chictr.org.cn/bin/project/edit?pid=293180，注册号ChiCTR2500111782。

英文摘要

INTRODUCTION: Chronic nonspecific neck pain (CNNP) is a prevalent and disabling musculoskeletal disorder frequently accompanied by cervical sensorimotor deficits and autonomic nervous system (ANS) dysregulation while conventional physical therapy (CPT) can reduce pain and disability, its effects are often limited in autonomic nerve system dysfunction. Eye movement exercise (EME) engages oculomotor-vestibular-proprioceptive networks and stimulates vagal-parasympathetic pathways, offering potential synergistic benefits. However, clinical evidence supporting an EME-integrated rehabilitation regimen in CNNP is scarce. This trial aims to evaluate the efficacy of EME + CPT compared to CPT alone on relieving pain intensity, disability intensity, autonomic regulation, and quality of life for CNNP.
METHODS: A single-centre, assessor-blinded randomized controlled trial will recruit 60 adults with CNNP ≥12 weeks. Participants will be randomly assigned (1:1) to either CPT alone or CPT + EME group. Interventions will be administered three times per week for four consecutive weeks (about 60 min per session). The primary outcome is pain intensity (measured using a 100-mm visual analogue scale, VAS). The prespecified primary endpoint is Day 30, and the primary treatment contrast is the between-group difference in mean change in VAS from baseline to Day 30. Secondary outcomes include neck disability index, cervical active range of motion, anxiety and depression severity and health-related quality of life. Heart rate variability (HRV) is prespecified as a secondary mechanistic outcome, whereas oculomotor performance and electrical sensory/pain thresholds, and eye movement accuracy are exploratory outcomes. Data will be collected at baseline, Day 15, and Day 30. The primary analysis will use a linear mixed-effects model under the intention-to-treat principle.
DISCUSSION: This trial will clarify whether integrating structured EME into a standard rehabilitation framework confers incremental short-term clinical benefits over conventional therapy of equal total duration. Exploratory autonomic and oculomotor endpoints will provide insight into underlying physiological associations rather than inferring direct causality, informing future large-scale, long-term rehabilitation trials.
CLINICAL TRIAL REGISTRATION: https://www.chictr.org.cn/bin/project/edit?pid=293180, identifier ChiCTR2500111782.