Protocol for a Randomized Clinical Trial of Oculomotor Exercises Added to Treatment for Temporomandibular Disorders

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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Abstract

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.
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
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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