Randomized Clinical Trial of Electrostimulation Therapies With Implementation of Multifractal Electromyographic Analysis for Patients With Temporomandibular Disorders
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 84
- 主要终点
- Muscular fatigue
研究概览
简要总结
The objective is to compare the neuromuscular electrical activity and muscle fatigue of the masseter muscles in three groups of patients with different treatments for TMD (GA = Transcutaneous electrostimulation and splint, GB = percutaneous electrostimulation and splint, and GC = Occlusal splint) by means of 6 electromyographic recordings scheduled weekly.
The study population will be patients with TMD who will enter the Physiology Laboratory of the Division of Postgraduate Studies and Research (DEPeI) UNAM, admitted during the period from March to December 2021 The selection of the sample will be carried out by convenience sampling which will be carried out based on the clinical evaluation (considering the inclusion and exclusion criteria). The recruitment period will take place during the period from March to December 2021.
The selected sample will be divided into three groups (GA = transcutaneous electrostimulation and splint, GB = percutaneous electrostimulation and splint, GC = splint); the allocation by group will be made by means of a randomization in balanced blocks. The total sample size calculated for this study was 84 patients, 28 for each group.
The diagnostic process of Temporomandibular Dysfunction (TMD) will be carried out by the Principal Investigator using the Diagnostic Criteria and Investigation of Temporomandibular Disorders (CDI / TMD).
详细描述
Temporomandibular dysfunction or disorder (TMD) is a functional disorder of the temporomandibular joint (TMJ), and is the cause of non-dental pain in the orofacial region.
TMD presents diagnostic difficulties, the literature suggests objective assessment of neuromuscular activity. Electromyography (EMG) is a reliable tool to determine the degree of functional muscle alteration, the EMG signal can be estimated and characterized by multifractal analysis, for example, the Hurts Index. This method is used successfully in the study of physiological signals with high biological variability (signals: cardiac, cardiovascular, ophthalmological, neuronal, metabolic, etc.), it is considered suitable for the comprehensive analysis of neuromuscular behavior.
The objective is to compare the neuromuscular electrical activity (RMS) and muscle fatigue (Hurst index) of the masseter muscles in three groups of patients with different treatments for TMD (GA = Transcutaneous electrostimulation and splint, GB = percutaneous electrostimulation and splint, and GC = Occlusal splint) by means of 6 electromyographic recordings scheduled weekly.
The clinical examination will be performed in the order of the hands of the clock, beginning with the upper right quadrant. The first review will correspond to the presence of mixed dentition, use of prostheses, number of teeth, muscle pain (with a pressure algometer applying 1.5 kg / cm2 in masseter muscles, and 2.4 kg / cm2 in temporal muscles), joint pain (with algometer pressure applying 1.5 kg / cm2), presence of noises, limitation to mouth opening (with Terabite) and heart rate.
To assess pain by means of muscle and joint palpation with an algometer, the patient will be seated in a relaxed position, the evaluator will place the fine circular surface of the algometer perpendicular to the skin and an increasing pressure of 0.5 kg / cm2 will be applied increasing gradually over one minute until reaching 1.5 kg / cm2.
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)
盲法说明
Blind observer:
A third party (statesman) is used, who does not know the treatment that each person is receiving.
patient, to assess the response.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients assigned to the DEPeI Physiology Laboratory.
- •Age range 18 to 60 years
- •Without prior treatment of TTM or DTM
- •Permanent dentition
- •With malocclusion
- •With prosthetic or implant treatments
- •Partially toothless arches
- •Deviation to mandibular opening or closure
- •Presence of joint noises depending
- •Myofascial or joint pain
排除标准
- •Degenerative joint disease
- •Periodontal problems
- •Orthodontic treatment
- •Apparent neurological or sensory disabilities
- •Patients with bleeding disorders or with anticoagulant intake
- •Patients with pacemakers, defibrillators, or heart conditions
- •Epilepsy, thrombophlebitis, active or uncontrolled phlebitis
- •Facial wounds or severe acne
- •Apparent Neurological or muscular disorders
- •Allergic to metal
- •Acute inflammatory processes or infections
- •Joint surgical history
- •Malignancies
- •Degenerative bone diseases
- •Fibromyalgia
结局指标
主要结局
Muscular fatigue
时间窗: Two months (every week with a total of six continuous records)
Micro Voltios (µV.) Mathematical Hurst Index value determined by the EMG UNAM-CINVESTAV program, which represents the average of the squared values of the electromyographic activity of the right and left masseter muscles
Neuromuscular electrical activity
时间窗: Two months (every week with a total of six continuous records)
Mathematical Root Mean Square (RMS) value Micro Voltios (µV.) determined by the EMG UNAM-CINVESTAV program, which represents the average of the squared values of the electromyographic activity of the right and left masseter muscles.
次要结局
- Presence of joint noises(Two months (every week with a total of six continuous records))
- Muscle pain(Two months (every week with a total of six continuous records))
- Limitation of mouth opening(Two months (every week with a total of six continuous records))
- Heart rate(Two months (every week with a total of six continuous records))
- Temporomandibular dysfunction (DTM)(Day 1)
研究者
Claudia Ivonne Rodriguez Castañeda
Master of Clinical Dental Sciences
Universidad Nacional Autonoma de Mexico