Comparative Efficacy of Acupuncture, Dry Needle and Botox Injection in Management of Patient With Myofascial Pain Dysfunction Syndrome Using Electromyography and Visual Analogue Scale: A Randomized Clinical Trial
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- change of electrical activity of mastication muscles from the baseline measurement
研究概览
简要总结
Evaluating myofascial pain dysfunction symptoms using acupuncture, dry needle and Botox injection using electromyography and visual Analogue Scale on two time intervals at 2 and 6 months after the intervention
详细描述
All the patients will be selected and examine from the outpatient clinic of Oral and Maxillofacial surgery department. Faculty of Dentistry, Cairo University, Egypt.
Electromyography examination will be conducted in the department of neurophysiology department. faculty of Medicine, Cairo University, Egypt. Adult patients of both sexes, aged from 15 to 60 years with myofascial pain dysfunction syndrome complaining from sign and symptoms of pain or muscles spams and examination shows trigger points in masticatory muscles. selected patients must have not received any other form of surgical treatment related to TMJ disorders All patients involved in this study will be divided into three groups, each group will receive a technique for one side of MPDS, involving acupuncture, dry needle, and Botox injection.
for both, acupuncture group and dry needling group, patients should receive a session/week for 4-6 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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 15 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Volunteers
- •MPDS patient
- •Adult patients of both sexes, aged from 15 to 60 years
- •signs and symptoms of pain or muscles spams
- •Trigger points in masticatory muscles
- •Patients had not received any other form of surgical treatment related to TMJ disorders
- •Cooperative patient
排除标准
- •Severe bleeding tendency, e.g. anticoagulant therapy, thrombocytopenia
- •Edentulous patients, and total dental prosthesis.
- •Psychologically disturbed and mental disturbance patients
- •major systemic disorders (- Valvular heart disease: avoid indwelling needles)
- •seizure patients
- •A confirmed or suspected diagnosis of an inflammatory disorder and autoimmune.
- •Patient on Medication (insulin- corticosteroids, nonsteroidal anti-inflammatory therapy or narcotics, muscle relaxants, herbal medicines.)
- •Analgesic or anti-depressants over the last 2 weeks.
- •Any anatomical abnormality in TMJ.
- •Pregnant women.
- •Allergies to metals.
研究组 & 干预措施
Acupuncture needle (study group A)
a weekly session for 4-6 weeks on needle for each acupoint for at least 20 minutes the included acupoints are ST6, ST7, SI 18, ST 19, GB 2
干预措施: Acupuncture needle (Device)
Dry needle (study group B)
a weekly session for 4-6 weeks the trigger point is held by thumb and index fingers and the needle approaches the point perpendicular to the skin and rotated clockwise for 2-3 minutes
干预措施: Dry needle (Device)
Botox injection (study group C)
each patient will receive a one time treatment of a suitable dose (estimated by the research team) according to the severity of the symptoms
干预措施: Botox Injectable Product (Drug)
结局指标
主要结局
change of electrical activity of mastication muscles from the baseline measurement
时间窗: 6 months after treatment
change of electrical activity of mastication muscles from the baseline measurement through assessment of muscle tone using electromyography (EMG) in microvolts and refer to the behavior of muscles: at (rest /open, chewing, clenching)
次要结局
- change of Pain perception from baseline measurement during maximum mouth opening in millimetres and rest by a Visual Analog Score (where Zero means no pain and 10 means the worst pain possible)(6 months after treatment)
研究者
Wajmah Sayed Karim Al Sayed
Principal investigator
Cairo University