Investigation of the Effectiveness of Manual Therapy and Splint Therapy in Patients With Myofascial Temporomandibular Dysfunction Combined With Bruxism
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Change from Baseline in Pain severity at 4 weeks
研究概览
简要总结
The aim of this study was to compare the efficacy of splint treatment and manual therapy in patients diagnosed with myofascial temporomandibular dysfunction with bruxism.
详细描述
A total of 56 patients were evaluated. Among those, 20 patients who did not meet the criteria were excluded. 36 patients met the inclusion criteria and were willing to participate in the study.
The patients were randomly separated into two groups using the method of single- and double-digit numbers written on paper in a sealed envelope.
Those who selected a double-digit number were assigned to the manual therapy (MT) group (n:18) and those with a single-digit number to the splint therapy (ST) group (n:18).
After the further exclusion of 7 patients during the treatment period, the final evaluations were compared of 29 patients (15 MT and 14 ST) who completed the 4-week treatment process.
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 (Participant)
盲法说明
Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Ages between 18 and 50 years old,
- •Patients with a diagnosis of myofascial TMD with Bruxism according to the diagnostic criteria for temporomandibular disorders (DC/TMD),
- •Having pain severity ≥3 according to the Visual analogue scale (VAS),
- •Probable sleep bruxism according to clinical evaluation and a questionnaire-based assessment.
排除标准
- •Patients with a diagnosis other than myofascial TMD according to the research DC/TMD,
- •a history of surgery associated with cervical and/or TMJ problems,
- •a proven specific pathological condition such as cervical and/or TMJ malignancy, fracture, or systemic rheumatoid disease,
- •a history of facial paralysis, a diagnosed psychiatric disease,
- •if they were undergoing orthodontic treatment,
- •had received physiotherapy within the last 3 months,
- •or could not be co-operative.
结局指标
主要结局
Change from Baseline in Pain severity at 4 weeks
时间窗: Baseline, 4 weeks
Pain severity was measured with a Visual Analogue Scale (VAS), marked from 0 to 10, where 0 indicates no pain and 10 indicates intolerable pain. The patients were instructed to mark the scale corresponding to the severity of pain felt.
Change from Baseline in Jaw Function limitation at 4 weeks
时间窗: Baseline, 4 weeks
Jaw function limitation was measured by the Jaw Functional Limitation Scale-20 (JFLS-20) where the patients asked for from 1 to 10 points per item (higher scores indicate worse jaw function). The JFLS-20 has 3 subscales: Mastication (6 items), Vertical Jaw Mobility (4 items), and Emotional and Verbal Expression (10 items).
Change from Baseline in Headache severity at 4 weeks
时间窗: Baseline, 4 weeks
The Headache Impact Test-6 (HIT-6) was used to assess the headache. The 6-item scale evaluates the frequency, the degree of restriction to daily life and social life, and changes in the mood. The total score of 50-59 reflects the important impact, and scores ≥60 indicate severe impact.
Change frim Baseline in Fatigue severity at 4 weeks
时间窗: Baseline, 4 weeks
Fatigue level was measured with the Fatigue Severity Scale, where patients were asked to indicate their levels of agreement with a 0-7 scale indicating "0" strong disagreement and "7" strong agreement at a total of 9 questions. A sum of all responses was calculated for analysis. Sixty-three was the maximum score. The higher value represented a higher level of fatigue.
Change from Baseline in Sleep quality at 4 weeks
时间窗: Baseline, 4 weeks
The sleep quality of patients was analyzed with the Pittsburgh Sleep Quality Index (PSQI). The PSQI includes 24 items related to both daytime and nocturnal sleep. The responses were scored from 0-3, as 7 subscores to give a global score of total points in the range of 0-21. A score of ≥5 indicated poor sleep quality.
Change from Baseline in Neck Disability at 4 weeks
时间窗: Baseline, 4 weeks
Neck Disability Index, consists of 10 items. Individuals included in the study were asked to give a score between 0 (no disability) and 5 (complete disability) for each item. The total score varies between 0 (no disability) and 50 (complete disability).
Change from Baseline in Patient Satisfaction questionnaire at 4 weeks.
时间窗: Baseline, 4 weeks
The Patient Satisfaction questionnaire was used to assess the patient's satisfaction with the treatment received. The patient satisfaction questionnaire (PSQ) contains 18 items tapping each of the seven dimensions of satisfaction with medical care measured by the PSQ-18.
次要结局
- Change from Baseline in Head Posture at 4 weeks(Baseline, 4 weeks)
- Change from Baseline in Trigger points at 4 weeks(Baseline, 4 weeks)
- Change from Baseline in Cervical Range of Motion at 4 weeks(Baseline, 4 weeks)
- Change from Baseline in Temporomandibular Joint Range of Motion at 4 weeks(Baseline, 4 weeks)
研究者
Süreyya DAMAR ÖRENLER
Principal Investigator
Turkoglu Dr. Kemal Beyazit State Hospital