Tele-Rehabilitation in Patients With Temporomandibular Dysfunction: Randomized, Controlled and Blind
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Score in Numerical Pain Scale
研究概览
简要总结
Temporomandibular disorder or TMD is characterized by a set of symptoms such as: pain, decreased range of motion and joint noise. It's origin is multifactorial, which may be related to biological aspects, environmental and psychosocial. The multimodal approach has been widely used in physiotherapy for the treatment of TMDs. Physiotherapy has been walking together with technology so that telerehabilitation can be a reality, contributing so that quality care reaches the patient, in the impossibility office-to-face service. The objective of this study is to verify the effect of telerehabilitation on pain outcomes, range of motion, functionality and biopsychosocial aspects in individuals with temporomandibular disorders. Will be a randomized, controlled and blinded clinical trial was carried out. The study will be divided into two moments: evaluation and intervention. Evaluations will be carried out using the Diagnostic Criteria for Temporomandibular Disorders: Clinical Protocol and Assessment Instruments (DC/TMD), the Fonseca Anamnesis Index (IAF), the Numerical Pain Scale (END) and the Functional Limitation Questionnaire (MFIQ). Individuals will be randomized into 2 groups: Group A (in person) Group B (telerehabilitation). Both groups will receive treatment physical therapy for 12 weeks. After collecting the data, they will be tabulated and analyzed using a 5% significance level.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Two researchers will be part of the protocol. One will be responsible for pre and post intervention assessments and will be blind to the type of intervention. The other will be responsible for the treatment phase: face-to-face and telerehabilitation. A third party collaborator will process and statistically analyze the collected data. Individuals will be randomized using the statistical program present at www.randomization.com , in two groups. Randomization and concealment of allocation will be made by a fourth external employee, not research participant, who will organize the allocation in individual opaque envelopesand keep it confidential. There will be 2 blocks of 25 envelopes: face-to-face (GA) and telerehabilitation (GB). With this process, participants will have the same probability of being allocated to one of the two treatment groups. Blinding of the evaluator will be maintained until the end of the research and data tabulation.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
face-to-face group
The patient will be submitted to multimodal treatment, twice a week, for twelve weeks, totaling 24 face-to-face consultations lasting 40 minutes each. In the first session, the patient will be explained what is TMD, what is the correct placement of the tongue and teeth, influence of parafunctional and sleep habits in TMD signs and symptoms.Techniques of manual therapy and therapy by exercise. In general, extra-oral and intraoral massage, myofascial release in the cranio-cervical musculature, mobilization of the hyoid bone and may also receive unspecific joint mobilization. Will be mouth opening exercise will be also performed with the tongue on the palate, proprioceptive exercises with hyperboloid. In addition to these, additional exercises may be performed, according to the patient's need. The conducts will be adapted according to the needs of each patient. The use of post its may be indicated to help maintain the correct posture of the tongue and jaw, as well as sleep hygiene.
干预措施: manual therapy and therapy by exercise (Other)
telerehabilitation
The patient will be submitted to multimodal treatment, twice a week, for twelve weeks, by telerehabilitation lasting 40 minutes each.A physiotherapist through video call via WhatsApp application. In the first session, the patient will be explained what is TMD, what is the correct placement of the tongue and teeth, influence of parafunctional and sleep habits in TMD signs and symptoms. Patients will be instructed to perform extra-oral and intra-oral self-massage and in the cranio-cervical musculature, bone mobilization hyoid, which would replace the mobilization unspecific articulation performed in person.Exercise will also be carried out mouth opening with tongue on the palate, exercises proprioceptives with hyperboloid. The conducts will be adapted according to the needs of each patient.The conducts will be adapted according to the needs of each patient.The use of post its may be indicated to help maintain the correct posture of the tongue and jaw, as well as sleep hygiene
干预措施: manual therapy and therapy by exercise (Other)
结局指标
主要结局
Score in Numerical Pain Scale
时间窗: The level of pain at 6 months
intensity of pain
measure range of motion
时间窗: The range of motion at 6 months.
range of motion
次要结局
- measure Functionality(The functionality at 6 months.)
- Biopsychosocial analysis.(The biopsychosocial analysis at 6 months.)
研究者
Daniela Ap. Biasotto-Gonzalez
PhD, professor and researcher
University of Nove de Julho