The Application of Manual Techniques in Masticatory Muscles Relaxation as Adjunctive Therapy in the Treatment of Temporomandibular Joint Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 主要终点
- Change From Baseline Electrical Activity of the Anterior Part of the Temporal and Masseter Muscles at 10, and 14 days
研究概览
简要总结
The aim of the study was to compare the degree of relaxation of the anterior part of the temporal muscles and the masseter muscles achieved with the use of post-isometric relaxation and myofascial release methods in patients requiring prosthetic treatment due to temporomandibular joint disorders (TMD) with a dominant muscular component.
The study included 60 patients, both sexes, aged between 19 and 40. The patients who met the inclusion criteria were alternately assigned to one of the two study groups: I group consisted of the patients received post-isometric relaxation treatment (PIR), II group - patients received myofascial release treatment (MFR). Each group consisted of 30 subjects. The series of ten treatments were performed in both groups. The comparative assessment was carried out based on the data obtained from the physical examination, physiotherapeutic examination of the masticatory system, surface electromyography (sEMG) of anterior temporal and masseter muscles and the data on the intensity of spontaneous masticatory muscle pain assessed using the Visual Analogue Scale (VAS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
入排标准
- 年龄范围
- 19 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosed functional disorders of the masticatory system with the accompanying excessive tension of the masseter muscles,
- •no clinical signs of displacement of the disc with a blockage in the temporomandibular joint,
- •spontaneous pain in the masticatory muscles, lasting at least one month before treatment,
- •good general health of the patient,
- •full dental arches
- •written consent to participate in the study
排除标准
- •occurrence of a face or head injury during participation in the research project,
- •open wounds in the area where the therapy was carried out,
- •sudden illness of the patient preventing participation in the study,
- •the will to terminate participation in the study
结局指标
主要结局
Change From Baseline Electrical Activity of the Anterior Part of the Temporal and Masseter Muscles at 10, and 14 days
时间窗: Change From Baseline Electrical Activity of the Muscles at 10, and 14 days; Triple measurement: immediately before supportive treatment, after the last of the 10 relaxation treatments and on the 4th day after the end of therapy
The electrical activity of the anterior part of the temporal and masseter muscles was assessed by surface electromyography (sEMG). The assessment was performed using a two-channel device - NeuroTrac MyoPlus 4 (Verity Medical Ltd.) and surface electrodes (Noraxon inc.). Examination of the same muscles on the right and left sides of the body was performed at the same time. The muscle tone of the anterior part of the temporal muscles was assessed first, followed by the masseter muscles. The parameter describing the degree of electrical activity of the muscle was the mean value of the thirty-second sEMG measurement.
Change From Baseline in Muscle Pain Scores on the Visual Analog Scale at 10, and 14 days
时间窗: Change From Baseline in Muscle Pain Scores on the Visual Analog Scale at 10, and 14 days; Triple measurement: immediately before supportive treatment, after the last of the 10 relaxation treatments and on the 4th day after the end of therapy
Assessment of the intensity of spontaneous pain in the masticatory muscles The intensity of spontaneous pain in the masticatory muscles was assessed on the basis of a 10-point visual analogue scale(VAS).This scale included 11 pain grades- from 0 to 10,where 0 was no pain at all, 5 was moderate pain, and 10 was the strongest pain imaginable.
次要结局
未报告次要终点
研究者
Bartosz Trybulec
Principal Investigator
Jagiellonian University