Prott Lea S, Spitznagel Frank A, Hugger Alfons, Langner Robert, Gierthmühlen Petra C, Gierthmühlen Mortimer
Department of Prosthodontics, Medical Faculty and University Hospital Düsseldorf, Heinrich-Heine-University Düsseldorf, Moorenstraße 5, Düsseldorf, 40225, Germany.
Institute of Systems Neuroscience, Medical Faculty and University Hospital Düsseldorf, Heinrich Heine University Düsseldorf, Moorenstraße 5, Düsseldorf, 40225, Germany.
Pilot Feasibility Stud. 2024 Feb 8;10(1):27. doi: 10.1186/s40814-024-01447-x.
BACKGROUND: Temporomandibular disorders (TMD) are a collective term for pain and dysfunction of the masticatory muscles and the temporomandibular joints. The most common types of TMD are pain-related, which may impact the psychological behavior and quality of life. Currently, the most popular methods for the treatment of TMD patients are occlusal splint therapy, often in combination with physical- and/or pharmacotherapy. However, due to the complexity of etiology, the treatment of chronic TMD remains a challenge. Recently, CE-certified systems for non-invasive VNS (transcutaneous auricular vagus nerve stimulation, taVNS) have become available and show positive effects in the treatment of chronic pain conditions, like migraine or fibromyalgia, with which TMD shares similarities. Therefore, it is the main purpose of the study to evaluate the feasibility of daily taVNS against chronic TMD and to assess whether there is an improvement in pain severity, quality of life, and kinetic parameters. METHODS: This study is designed as a single-blinded, double-arm randomized controlled trial (RCT) in a 1:1 allocation ratio. Twenty adult patients with chronical TMD symptoms will be enrolled and randomized to stimulation or sham group. In the stimulation group, taVNS is performed on the left tragus (25 Hz, pulse width 250 µs, 28 s on/32 s off, 4 h/day). The sham group will receive no stimulation via a non-functional identical-looking electrode. Validated questionnaire data and clinical parameters will be collected at the beginning of the study and after 4 and 8 weeks. The compliance of a daily taVNS of patients with chronical TMD will be evaluated via a smartphone app recording daily stimulation time and average intensity. Additionally, the treatment impact on pain severity and quality of life will be assessed with different questionnaires, and the effect on the mandibular mobility and muscle activity will be analyzed. DISCUSSION: This is the first clinical trial to assess the feasibility of taVNS in patients with chronic TMD symptoms. If taVNS improves the symptoms of TMD, it will be a significant gain in quality of life for these chronic pain patients. The results of this pilot study will help to determine the feasibility of a large-scale RCT. TRIAL REGISTRATION: This study has been registered in the DRKS database (DRKS00029724).
背景：颞下颌关节紊乱病（TMD）是咀嚼肌和颞下颌关节疼痛及功能障碍的统称。TMD最常见的类型与疼痛相关，这可能会影响心理行为和生活质量。目前，治疗TMD患者最常用的方法是咬合板治疗，通常与物理治疗和/或药物治疗相结合。然而，由于病因复杂，慢性TMD的治疗仍然是一项挑战。最近，经CE认证的非侵入性迷走神经刺激系统（经皮耳迷走神经刺激，taVNS）已可供使用，并在治疗慢性疼痛病症（如偏头痛或纤维肌痛）中显示出积极效果，而TMD与之有相似之处。因此，本研究的主要目的是评估每日进行taVNS治疗慢性TMD的可行性，并评估疼痛严重程度、生活质量和动力学参数是否有所改善。 方法：本研究设计为一项单盲、双臂随机对照试验（RCT），分配比例为1:1。将招募20名有慢性TMD症状的成年患者，并随机分为刺激组或假刺激组。在刺激组中，在左耳屏进行taVNS（25赫兹，脉冲宽度250微秒，开启28秒/关闭32秒，每天4小时）。假刺激组将通过外观相同但无功能的电极不接受刺激。在研究开始时以及4周和8周后收集经过验证的问卷数据和临床参数。将通过智能手机应用程序记录每日刺激时间和平均强度，评估慢性TMD患者每日taVNS的依从性。此外，将使用不同问卷评估治疗对疼痛严重程度和生活质量的影响，并分析对下颌运动和肌肉活动的作用。 讨论：这是第一项评估taVNS对有慢性TMD症状患者可行性的临床试验。如果taVNS能改善TMD症状，对于这些慢性疼痛患者来说将是生活质量的显著提高。这项初步研究的结果将有助于确定大规模RCT的可行性。 试验注册：本研究已在DRKS数据库（DRKS00029724）中注册。
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