Clinical Efficacy of Acupuncture in the Treatment of Temporomandibular Disorders(TMD)
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Visual analogue scale(VAS)
研究概览
简要总结
This is a single-blinded, randomized controlled trial to explore the effectiveness of acupuncture in the treatment of the pain due to TMD using the latest diagnostic criteria combined with subjective and objective indexes.
详细描述
This is a single-blinded, randomized controlled clinical trial. A total of 60 participants will be randomly assigned to two different groups. The treatment group will receive acupuncture with real penetration of the needle, while participants in the control group will be treated with the Park sham needle. All participants will be given for 4 weeks of treatment and 4 weeks of follow-up.The primary end-point is the reducing in intensity of pain due to TMD, which will be evaluated before treatment, 4 weeks after treatment and follow-up (4 weeks after treatment) by using 0-10 visual analogue score. Secondary end points include Graded Chronic Pain Scale Version 2.0(GCPS 2.0),Jaw Functional Limitations Scale - 20-item (JFLS-20),Depression, Anxiety and Stress Scales (DASS-21),Pittsburgh sleep quality index (PSQI),Pressure Pain Threshold (PPT),Surface electromyogram(sEMG).
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)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pain disorders in accordance with Diagnostic Criteria for Temporomandibular Disorders (DC/TMD)
- •Pain in the jaw, temple, in the ear, in front of ear or headache in the temple at any sides, and pain or headache modified (remission or aggravation) with movement at least 3 months.
- •Cooperated in completing the clinical trial successfully without language and mental disorders.
排除标准
- •Conditions that result in regional pain in temporomandibular joint.
- •Autoimmune diseases that result in regional pain in the temporomandibular joint.
- •Mental illness or substance abuse.
- •Pregnant women.
研究组 & 干预措施
Treatment group
In the treatment group, the Park needle with a real acupuncture will be penetrated in an appropriate angle into a depth of 10-15 mm. Acupuncture manually manipulated by lifting, thrusting, and twirling methods to produce a characteristic sensation known as "De Qi" (feeling of needle sensation refers to tenseness around the needle felt by the practitioner and numbness, distension, soreness, and heaviness around the point felt by the patient), and needles will be stimulated manually at least 10 s, then the needles will be retained for 30 minutes.
干预措施: Acupuncture (Device)
Control group
In the control group, the Park sham needle will instead of the real needle. It is retractile and adopts the sleeve type blunt needle design. When the blunt needle goes through the adhesive and contact with skin, it will move back into the hollow centre of the handle rather than penetrate into skin. The sham needle may be manipulated by lifting, thrusting or twirling as the real one, but it will not insert into the skin authentically.
干预措施: The park sham needle (Device)
结局指标
主要结局
Visual analogue scale(VAS)
时间窗: Baseline,Week- 4(treatment period) and Week-8(follow-up period)
VAS is an international scale which reflects pain intensity and it has a 10-cm line ranging from 0 cm (no pain at all) to 10 cm (extremely painful). Pain intensity or pain relief in the tempormandibular joints will be measured by VAS. And then the investigators will compare the change of different time frames.The total score of this index is 10, and the better effect with the lower score.
次要结局
- Graded Chronic Pain Scale Version 2.0(GCPS 2.0)(Baseline,Week- 4(treatment period) and Week-8(follow-up period))
- Surface electromyogram(sEMG)(Baseline and Week- 4(treatment period))
- Jaw Functional Limitations Scale - 20-item (JFLS-20)(Baseline,Week- 4(treatment period) and Week-8(follow-up period))
- Depression, Anxiety and Stress Scales (DASS-21)(Baseline,Week- 4(treatment period) and Week-8(follow-up period))
- Pressure Pain Threshold (PPT)(Baseline and Week- 4(treatment period))
- Pittsburgh sleep quality index (PSQI)(Baseline,Week- 4(treatment period) and Week-8(follow-up period))
研究者
Li bin
Acupuncture director
Beijing Hospital of Traditional Chinese Medicine