Investigation of the Effectiveness of Telerehabilitation in Individuals Myofascial Temporomandibular Dysfunction With Bruxism
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change from Baseline in Pain at 4 weeks and 8 weeks
研究概览
简要总结
The aim of the study is to compare the effects of Home Exercise Therapy (HET) and Telerehabilitation in patients with myofascial temporomandibular disorders (TMD)with bruxism.
详细描述
Home Exercise will be Group 1 and Telerehabilitation group will be Group 2.
Group 1 HET, will include an educational training program about parafunctional activities of TMD disorders and bruxism and active exercises for 4 weeks.
As part of the Home exercise program, a written document will be prepared, including relaxation, breathing training, posture, stretching, and strengthening exercises to be given to the patients.
Group 2, in addition to the training and written document, the second group will receive the same exercises using telerehabilitation once a week by video call, and reminder messages will be sent to the patients 3 times a week.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages between 18 and 65 years old
- •Patients with TMD in the myofascial Group Ia, Ib according to the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) and diagnosed with bruxism
- •Having pain ≥ 3 according to the Visual Analog Scale
- •Those who have not received medical treatment for the last 3 months and will not receive it during the treatment process will be included in the study.
排除标准
- •Ages under 18 and over 65 years old
- •Patients with disc displacement and/or TMJ degeneration
- •Patients who have orthodontic or splint treatment
- •Patients with musculoskeletal problems in which systemic specific pathological conditions such as cervical and/or temporomandibular joint (TMJ) problem malignancy, fracture, the rheumatoid disease is proven
- •Patients who have undergone any surgery related to the cervical and/or TMJ
- •Patients with facial paralysis
- •Patients who regularly use analgesic or anti-inflammatory drugs
- •Patients who have received physical therapy associated with TMJ in less than 3 months
- •Patients with a history of trauma (whiplash injury, condylar trauma, fracture)
- •Patients with cognitive deficits
- •Participation rate lower than 80% of the program schedule
结局指标
主要结局
Change from Baseline in Pain at 4 weeks and 8 weeks
时间窗: Baseline, 4 weeks, 8 weeks
Visual Analog Scale will be used where patients will be asked to rate their pain on a scale from 0 to 10 with 0 indicating no pain and 10 the maximum worst pain, at the baseline and the end of 4 weeks intervention and at the end 8 weeks from baseline.
Change from Baseline in Oral Behavior at 4 weeks and 8 weeks
时间窗: Baseline, 4 weeks, 8 weeks
Evaluation of oral habits with the Oral Habits Questionnaire consisting of 21 items, each item was evaluated according to the frequency of complaints as "4 = always; 3 = most of the time; 2 = sometimes; 1 = several times or 0 = none". The questions cover the times of sleep and wakefulness. The overall score ranges from 0 to 84.
Change from Baseline in Headache at 4 weeks and 8 weeks
时间窗: Baseline, 4 weeks, 8 weeks
Headache Impact Test-6 test consists of 6 questions about the severity of headache, the effect of pain on daily life activities, how often it causes fatigue and low motivation, and concentration impairment. Scoring is done between 36-78.
Change from Baseline in Mandibular range of movements at 4 weeks and 8 weeks
时间窗: Baseline, 4 weeks, 8 weeks
Maximum mouth opening, mandibular lateral right and left shift, and mandibular protrusion range of motion measurements in mm.
Change from Baseline in Neck disability at 4 weeks and 8 weeks
时间窗: Baseline, 4 weeks, 8 weeks
Neck Disability Index, consisting of a total of ten titles, was developed by Vernon and Mior in 1991. It includes topics such as pain intensity in the neck, personal care, lifting, reading, headaches, concentration, driving, sleep, and leisure activities. The maximum score is 50, while the minimum is 0 points. Classification according to total score is as follows: 0-4 (no restrictions); 5-14 (mild restriction); 15-24 (moderate restriction); 25-34 (severe limitation); 34 and above (completely limited).
Change from Baseline in Sleep Quality at 4 weeks and 8 weeks
时间窗: Baseline, 4 weeks, 8 weeks
Pittsburg Sleep Quality Index test is used to evaluate sleep effects in the last few months. This questionnaire contains 24 questions, 19 of which are personal, and 5 of which are to be answered by a partner about sleep during both day and night. Five questions answered by the partner are not included in the scoring. Self-assessment questions contain different items related to sleep quality, which provide information about sleep duration, latency, and the frequency and severity of specific sleep problems. The total score is between 0-21. A score of 5 and below indicates good sleep quality, and a score above 5 indicates poor sleep quality.
Change from Baseline in Quality of life at 4 weeks and 8 weeks
时间窗: Baseline, 4 weeks, 8 weeks
The individual's personal perception of how oral health affects their quality of life and general health is measured. Oral Health Impact Profile-14 is a scale system that evaluates this perception with questions for functional limitation, physical pain, psychological discomfort, physical, psychological and social inadequacy, and disability measures. It is concluded that as the total score increases, the severity of the problem increases, and the quality of life decreases.
次要结局
- Change from Baseline in Anxiety at 4 weeks and 8 weeks(Baseline, 4 weeks, 8 weeks)
- Change from Baseline in Fatigue at 4 weeks and 8 weeks(Baseline, 4 weeks, 8 weeks)
- Change from Baseline in Head and Shoulder Posture at 4 weeks and 8 weeks(Baseline, 4 weeks, 8 weeks)
研究者
Ezgi Hatice Giray
Research assistant
Hasan Kalyoncu University