Intra-articular Injection Versus Normal Rehabilitation Therapy on Temporomandibular Joint Dysfunction: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 主要终点
- Friction Index
研究概览
简要总结
The goal of this clinical trial is to study about the clinical effect of Intra-articular Injection on Temporomandibular Joint Dysfunction
The main question it aims to answer is:
• Can Intra-articular Injection help improve the Temporomandibular Joint Dysfunction Participants will be randomly assigned into the experimental group and the control group, all under comprehensive treatment. The experimental group will be given Intra-articular Injection additionally, The study lasts 15 days for each patient. Researchers will compare the assessments between the two groups to see if Intra-articular Injection can help improve the Temporomandibular Joint Dysfunction
详细描述
The background of Temporomandibular Joint Dysfunction is that it is one of the common diseases in the oral and maxillofacial region, and it is the most common among temporomandibular joint diseases. It is more prevalent in young adults, with the highest prevalence rate at 20-30 years old.
The goal of this clinical trial is to study about the clinical effect of Intra-articular Injection on Temporomandibular Joint Dysfunction
The main question it aims to answer is:
• Can Intra-articular Injection help improve the Temporomandibular Joint Dysfunction Participants will be randomly assigned into the experimental group and the control group, all under comprehensive treatment. The experimental group will be given Intra-articular Injection additionally, The study lasts 15 days for each patient. Researchers will compare the assessments between the two groups to see if Intra-articular Injection can help improve the Temporomandibular Joint Dysfunction
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presence of significant temporomandibular disorder clinical symptoms.
- •Meeting the diagnostic criteria for Temporomandibular Joint Dysfunction and confirmed by X-ray examination.
- •Patients voluntarily participate in this study and provide signed informed consent.
- •Normal cognitive function
排除标准
- •Rheumatic, rheumatoid, or other severe systemic diseases.
- •Infectious temporomandibular joint arthritis or joint tumors.
- •Individuals who have recently received joint injection treatment or photodynamic therapy.
研究组 & 干预措施
Routine rehabilitation treatment+Intra-articular Injection
The patients receive a 15-day treatment and are required to stay in the hospital during this period. Patients in the experimental group are given routine rehabilitation treatment and intra-articular injections. Lidocaine is used as the injected medication at a dose of 2ml, administered once every 5 days for a total of three injections.
干预措施: Routine rehabilitation treatment (Behavioral)
Routine rehabilitation treatment+Intra-articular Injection
The patients receive a 15-day treatment and are required to stay in the hospital during this period. Patients in the experimental group are given routine rehabilitation treatment and intra-articular injections. Lidocaine is used as the injected medication at a dose of 2ml, administered once every 5 days for a total of three injections.
干预措施: Intra-articular Injection (Procedure)
Routine rehabilitation treatment+Intra-articular Injection
The patients receive a 15-day treatment and are required to stay in the hospital during this period. Patients in the experimental group are given routine rehabilitation treatment and intra-articular injections. Lidocaine is used as the injected medication at a dose of 2ml, administered once every 5 days for a total of three injections.
干预措施: Lidocaine Hydrochloride (Drug)
Routine rehabilitation treatment
The patients receive a 15-day treatment and are required to stay in the hospital during this period. Patients are given routine rehabilitation treatment.
干预措施: Routine rehabilitation treatment (Behavioral)
结局指标
主要结局
Friction Index
时间窗: day 1 and day 15
Friction Index is used to assess temporomandibular function. The total scores range from 0 to 57, with higher scores indicating more severe temporomandibular dysfunction.
次要结局
- The Visual Analog Scale(day 1 and day 15)
- The maximum mouth opening limit(day 1 and day 15)
- Mann Assessment of Swallowing Ability(day 1 and day 15)
研究者
Copka Sonpashan
The Research Director
Chao Phya Abhaibhubejhr Hospital