Efficacy of Acupuncture and Low-Level Laser in Temporomandibular Disorders
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Visual analogue scale(VAS)
研究概览
简要总结
Temporomandibular joint disorders (TMD) , a musculoskeletal condition , includes a series of clinical problems involving the temporomandibular joint (TMJ), the masticatory muscles, and related structures.This study evaluates the efficacy of integrated traditional Chinese and western medicine in the treatment of TMD.
详细描述
In this study, 84 patients ranging in age from 18 to 65 years with diagnoses of TMD will be randomly divided into two groups: an experimental group (EG) who will receive the integrated traditional Chinese and western medicine treatment group(with Low-Level Laser Therapy+acupuncture) and a control group who will receive the only western medicine treatment(with Low-Level Laser Therapy).Both approaches will be applied 3times a week for 3 weeks.
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
- None
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
- •diagnosis of TMD according to the Diagnostic Criteria for TMD Research Diagnostic Criteria (DC/TMD）which are manifested as joint pain during mouth opening and chewing, mouth opening limitation (<40mm), joint clanging, masticatory creatine distension and weakness, which affects normal eating.
- •Aged 18-65;
- •Unilaterally;
- •No any other treatment on TMD in the last 3 months;
排除标准
- •there are tumors, joint degeneration and other serious lesions ;
- •Patients with a history of TMJ trauma or surgery,joint anatomical variation;
- •women pregnant and suckling period;
- •serious systemic diseases of bone and joint, such as rheumatoid arthritis
结局指标
主要结局
Visual analogue scale(VAS)
时间窗: Change from baseline Visual analogue scale at week 3
TMD pain will be quantified by the VAS, which is a 10-cm line ranging from 0 cm (no pain at all) to 10 cm (the worst possible pain). The patients are instructed to choose the grade of their spontaneous pain intensity on the 10 points scale during resting, mouth opening, and chewing.And then the operator takes the maximum from that.
次要结局
- Tempommandibular Opening Index(TOI)(Change from baseline Tempommandibular Opening Index at week 3)