在颞下颌关节紊乱症治疗中加入眼球运动锻炼的随机临床试验方案

Letícia Neves Mode, Cindy Mozer Nakamura, T. Cunha, Fernanda Cardoso Nakamoto, M. Leonardis, Cid André Fidelis de Paula Gomes, F. Politti, D. Biasotto-Gonzalez
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摘要

目的评估在治疗颞下颌关节紊乱症(TMD)的过程中加入眼部运动锻炼对治疗后即刻、3 个月和 6 个月的疼痛强度、下颌骨活动范围、TMD 严重程度和眼球辐辏不全(CI)的影响。研究设计:对照和随机临床试验,评估者和参与者均为盲人。研究方法:年龄在 18-45 岁之间、被诊断患有 TMD 和辐辏功能障碍的患者。干预:两组:实验组(EG)和对照组(CG)将接受 12 次治疗。主要结果测量:治疗后3个月和6个月随访期间的疼痛强度、下颌骨活动范围、辐辏不足和TMD严重程度。分析:统计分析将采用基于意向治疗的线性混合模型。显著性水平设定为 5%。结果:本研究为初步方案,研究完成后将公布结果。预计会有相关的患者临床改善结果。结论:可以确定在治疗 TMD 时增加眼球运动锻炼的效果。对实践的意义:如果成功,该方案可作为 TMD 传统疗法的辅助疗法纳入临床实践,从而扩大医护人员和患者的治疗选择范围。
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Protocol for a Randomized Clinical Trial of Oculomotor Exercises Added to Treatment for Temporomandibular Disorders
Objective: To evaluate the effect of adding oculomotor exercises to the treatment of Temporomandibular Disorder (TMD) on pain intensity, range of mandibular movement, TMD severity, and ocular convergence insufficiency (CI), immediately, 3 months, and 6 months after treatment. Study Design: Controlled and randomized clinical trial included blinded evaluators and participants. Methodology: Individuals aged 18–45 years diagnosed with TMD and convergence insufficiency. Intervention: Two groups: the experimental group (EG) and the control group (CG) groups will receive 12 treatment sessions. Main outcome measures: pain intensity, range of mandibular movement, convergence insufficiency, and severity of TMD during follow-up immediately after treatment, 3 and 6 months. Analysis: The statistical analysis will use linear mixed models based on the intention to treat. The significance level will be set at 5%. Results: This is a preliminary protocol; results will be available once the study is completed. It is expected relevant patient clinical improvement results. Conclusion: It will be possible to determine the effects of adding oculomotor exercises in the treatment of TMD. Implications for Practice: If successful, the protocol could be integrated into clinical practice as an adjunct to conventional therapy for TMD, expanding the therapeutic options available to healthcare professionals and patients.
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