Effect of Exercises on Convergence Insufficiency in Individuals With Temporomandibular Disorders: Clinical, Randomized, Blinded Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Score in Numerical Pain Scale
研究概览
简要总结
Temporomandibular Disorder is a disorder that involves the muscles of mastication, the temporomandibular joint (TMJ), and associated structures. Convergence insufficiency (CI) is characterized by the inability of the eyes to perform the eye adduction movement together, to focus on a nearby object. Studies show that there is a relationship between the presence of TMD and its signs and symptoms in patients with convergence insufficiency. Given this, the research question of this clinical trial is whether the effect of oculomotor therapy would be effective in improving the signs and symptoms of Temporomandibular Disorder. The design of this research is a Clinical Trial, Randomized and Blind. It will be divided into two moments: evaluation and intervention. The evaluations will be carried out using the Diagnostic Criteria for Temporomandibular Disorders: Fonseca Anamnestic Index (IAF), Clinical Protocol and Assessment Instruments (DC/TMD), Mandibular function Impairment Questionnaire (MFIQ), Numerical Pain Scale (END), Convergence Test, Meersseman Test and Convergence insufficiency symptom Survey (CISS). Individuals will be randomized into 2 groups: Group A (Treatment for Temporomandibular Disorder) and Group B (Treatment Oculomotor plus Treatment for Temporomandibular Disorder). Both groups will receive physiotherapeutic treatment for 12 weeks. Patients will be reassessed shortly after treatment, 3 and 6 months later. For data analysis, the statistical significance considered will be p<0.05.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 60 years;
- •Presence of pain in the facial region in the last 6 months;
- •Presence of pain, at least 3 on the numeric pain scale (END), in the Temporomandibular Joint and/or masticatory muscles and in the last 6 months;
- •Diagnosis of myogenic Temporomandibular Disorder, by DC/TMD;
- •Moderate and Severe Temporomandibular Disorder carrier, according to Fonseca's Anamnestic Index;
- •Presence of Insufficiency of Convergence according to Convergence Test (TC) and by Convergence insufficiency symptom Survey (CISS).
排除标准
- •Permanent strabismus;
- •History of strabismus surgery;
- •History of cervical and/or craniofacial trauma/surgical procedure;
- •History of ocular nerve injury;
- •Neurological disorders;
- •disc disease ;
- •Systemic diseases;
- •Fibromyalgia diagnosis;
- •Previous treatments for TMD carried out in the last 3 months;
- •Previous treatments of Convergence Insufficiency with oculomotor therapy (no more than 2 months of treatment in the last year);
- •Occlusal treatment in progress;
- •Any ocular or systemic medication known to affect accommodation or vergence ;
- •Systemic diseases that affect ocular accommodation, vergence , and motility, such as multiple sclerosis, Graves' thyroid disease, myasthenia gravis, diabetes, and Parkinson's disease;
- •In continuous use of analgesics, anti-inflammatories, anxiolytics and/or antidepressants;
- •Pregnant women.
研究组 & 干预措施
Oculomotor Therapy
The procedures for oculomotor therapy will be arranged sequentially, from easiest to most difficult. It will consist of a convergence technique (Brock Cord and Barrille Cartouche) and an accommodative technique (Eccentric circles or lifesaving cards) and Eye Relaxation.
干预措施: Oculomotor Therapy (Other)
Therapy for Temporomandibular Disorder
Extra-oral and intra-oral massage: The main objective is to reduce pain as well as re-establish proper muscle length and flexibility. The patient will be instructed to use diaphragmatic breathing to promote relaxation during these massage procedures.
Myofascial release of the masseter, temporalis and sternocleidomastoid muscles, release of neck soft tissues, cervical pomp, suboccipital inhibition, passive anteroposterior mobilization of the upper cervical, cervical exercises, Temporomandibular Joint exercises (mouth opening exercise with tongue on palate) , Proprioceptive exercises).
干预措施: Oculomotor Therapy (Other)
Therapy for Temporomandibular Disorder
Extra-oral and intra-oral massage: The main objective is to reduce pain as well as re-establish proper muscle length and flexibility. The patient will be instructed to use diaphragmatic breathing to promote relaxation during these massage procedures.
Myofascial release of the masseter, temporalis and sternocleidomastoid muscles, release of neck soft tissues, cervical pomp, suboccipital inhibition, passive anteroposterior mobilization of the upper cervical, cervical exercises, Temporomandibular Joint exercises (mouth opening exercise with tongue on palate) , Proprioceptive exercises).
干预措施: Therapy for Temporomandibular Disorder (Other)
结局指标
主要结局
Score in Numerical Pain Scale
时间窗: The level of pain at 3 months
intensity of pain
次要结局
- measure range of motion(The range of motion at 3 months)
研究者
Daniela Ap. Biasotto-Gonzalez
Clinical Professor
University of Nove de Julho