Effectiveness of Manual Therapy Added to Splint Therapy Compared to Splint Therapy Alone in the Treatment of Temporomandibular Disorders in Patients Intended for Orthodontic Treatment: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Self reported Temporomandibular Functionning
研究概览
简要总结
A randomized clinical trial evaluates physiotherapy plus splint treatment versus conventional splint treatment in patients with myofascial-origin temporomandibular disorder (TMD). The study follows the ethical principles of the Declaration of Helsinki and has been approved by the Research Ethics Committee of the University of Jaén.
Methodology Participants, recruited from three dental clinics in Spain, must be adults diagnosed with TMD according to the Diagnostic Criteria for Temporomandibular Disorder (DC/TMD). Patients with health conditions that could hinder participation are excluded. They are randomly assigned to two groups: one receiving physiotherapy plus a splint, and the other receiving only a splint.
The sample size was calculated using G*Power, determining that at least 38 patients (19 per group) are required.
Assessments and Measurements Sociodemographic variables include age, sex, BMI, education level, and lifestyle habits. Various instruments are used to assess TMD and pain, such as the DC/TMD, the Fonseca Anamnestic Index, the Numerical Pain Rating Scale, and the Neck Disability Index.
Intervention Physiotherapy + splint group: Four 20-minute manual therapy sessions, including techniques for the temporomandibular joint and cervical muscles.
Splint-only group: Only splint use as prescribed by the dentist. Assessments are conducted before and after treatment for the physiotherapy group and at two time points for the splint-only group (before splint placement and one month later).
Data Analysis SPSS and MedCalc software will be used, with a 95% confidence level. Relationships will be analyzed through regression and Pearson correlation, and group comparisons will be performed using repeated measures ANOVA, Student's t-test, and Chi-square test. Effect size will be calculated using Cohen's d.
In conclusion, the study aims to determine the effectiveness of combined physiotherapy and splint treatment compared to splint-only treatment in patients with myofascial TMD.
详细描述
A randomized clinical trial of TM treatment has been designed on patients with TMD of myofascial origin susceptible to dental treatment, complying with the ethical principles for biomedical research in humans formalized in the Declaration of Helsinki. The study has been approved by the Research Ethics Committee of the University of Jaén.
SUBJECTS Subjects are duly informed and their acceptance to participate is formalized by signing an informed consent document where they are also asked for permission to use their photos for the study. Participants are recruited from the Nogales Orthodontic Clinic in Úbeda, the Javier Ruiz Sequera Dental Clinic in Torreperogil, and the SM Medicodental Clinic in Úbeda, Spain. Subjects of legal age affected by myofascial TMD are included, with the diagnosis made using the Diagnostic Criteria for Temporomandibular Disorder (DMD). On the other hand, patients who are not in good physical condition are excluded. The participants were not qualified to understand or carry out the study. The selected participants were randomised into two groups using the Epidat 3.1 software (Conselleria de Sanidade, Xunta de Galicia, Spain), and assigned to a treatment group with physiotherapy plus a splint or another with a conventional approach prescribed with a splint by their dentists.
CALCULATION OF SAMPLE SIZE The sample size was calculated using the G*Power software (latest version 3.1.9.7; Heinrich-Heine University of Düsseldorf, Düsseldorf, Germany) based on the data provided by De Resende et al. A two-tailed hypothesis was considered, 95% power, a p value of 0.05 and an effect size on the VAS of 0.27. A correlation between repeated measures of 0.5 and an effect size of 0.25 were also considered. Taking into account three assessments of the study variables and two study groups, the present study should include a total sample size of at least 38 patients, 19 per group.
MEASUREMENTS All measurements are performed by a trained physiotherapist, who will not know which group each patient belongs to.
The sociodemographic variables taken are age, sex, height, BMI, educational level, whether they work, smoking habits, alcohol habits and physical activity.
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)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants diagnosed with myofascial temporomandibular disorders according to DC/TMD criteria.
- •Participants over 18 years old (local legal age).
排除标准
- •Participants unable to understand the questionnaires and assessments required for the study due to any condition.
研究组 & 干预措施
Splint therapy alone
Intervention based on splint therapy
干预措施: Splint therapy (Other)
Manual therapy and splint therapy
Intervention based on manual therapy techniques and splint therapy
干预措施: Manual Therapy (Other)
Manual therapy and splint therapy
Intervention based on manual therapy techniques and splint therapy
干预措施: Splint therapy (Other)
结局指标
主要结局
Self reported Temporomandibular Functionning
时间窗: From the enrollment to end of treatment at one month
-Fonseca Anamnestic Index: self reported questionnaire about tamporomandibular symptoms.
Mouth opening
时间窗: From enrollment to the end of treatment at one month
Maximum mouth opening in millimeters
Temporomandibular functioning
时间窗: From enrollment to the end of treatment at one month
-Helkimo Clinical Dysfunction Index: temporomandibular symptoms index to be fulfilled by evaluator.
次要结局
- Cervical function(From enrollment to the end of treatment at one month)
- Pain in temporomandibular joint(From enrollment to the end of treatment at one month)
- Headache or Cephalea(From enrollment to the end of treatment at one month)
研究者
Alfonso Javier Ibáñez-Vera
PhD IN Physiotherapy, Full Professor
University of Jaén