Comparative Evaluation of Masseter Muscle stiffness by Muscle hardness meter and Ultrasound elastography in patients with Temporomandibular disorders -A case control study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Evaluation of hardness values of Masseter Muscle in patients with Temporomandibular disorders and healthy controls
研究概览
简要总结
This is a case-control study to evaluate and compare muscle hardness in patients with temporomandibular disorders and adult healthy volunteers. The sample size of the study is 160,80
cases and 80 controls.
The cases will include patients with Temporomandibular disorders who will be diagnosed based on DC/TMD criteria. The controls will be healthy adult volunteers
with no history of trauma or Temporomandibular joint pain.
A detailed clinical and extraoral examination of the Temporomandibular joint will be performed and recorded on a case history proforma. The visual analog scale values will be recorded for muscle pain.
The masseter muscle hardness will be measured by a muscle hardness meter and the values will be recorded.
The same patients will be subjected to Ultrasound elastography and the muscle stiffness values will be recorded on an elastogram on right and left sides. The thickness of the masseter
muscle will be assessed by USG bilaterally.
The primary outcome measures will be assessing the muscle hardness values in healthy patients and patients with Temporomandibular disorders. The secondary outcome measures will be correlating visual analog scale values with muscle stiffness and correlating masseter muscle thickness with muscle stiffness values obtained by using muscle hardness meter and USG Elastography and muscle hardness meter.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.The Diagnostic Criteria for Temporomandibular disorders (DC/TMD) Axis I will be used for the classification 2.Patients with Myofascial pain will be included in the study.
- •3.Both male and female patients aged between 18 to 50 years will be included in the study 4.Healthy controls comprising of 80 adult healthy volunteers (age, 18–50 years) with normal teeth and jaws, who will not be classified into groups I/II/III by DC/TMD, with no history of jaw movement dysfunction, pain in the temporomandibular joint, abnormalities in mouth opening, trauma or surgery involving TMJ over the previous 3 months and who agree to participate in this study.
排除标准
- •1.Participants who refused to give a written consent will be excluded from the study.
- •2.Terminally ill patients or patients with chronic morbidity will be excluded.
- •3.Patients with neurological diseases like stroke, cerebral palsy and parkinsonism.
- •4.Patients with pregnancy, bone diseases, systemic diseases, cancer, acute pain, a history of drug ingestion within the past week (e.g., analgesics, muscle relaxants and anti-inflammatory drugs) 5.Patients with psychiatric morbidities or patients on an antipsychotic medication 6.Patients with restricted mouth opening because of odontogenic infections 7.Participants with severe illness, unable to communicate, lunatic and uncooperative patients will be excluded from the study.
- •8.Participants with history of head and neck trauma and Ototoxicity.
结局指标
主要结局
Evaluation of hardness values of Masseter Muscle in patients with Temporomandibular disorders and healthy controls
时间窗: 1 month and six months
次要结局
- Correlation between Masseter Muscle pain in patients with Temporomandibular disorders(Correlation with Masseter muscle thickness and muscle hardness)