The Evaluation of EMG-biofeedback Therapy Efficiency in Management of Masticatory Muscles Pain
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The effect of EMG biofeedback therapy on pain symptoms measured by pressure pain threshold in Experimental group 2
研究概览
简要总结
This study evaluates beneficial effects of biofeedback therapy in reducing pain and increased tension of muscles occurring in patients with temporomandibular disorders (TMD). During the study Electromyography Biofeedback (EMG-Biofeedback)- assisted training lowering muscle tension will be used. The patients will undergo 4 or 8 meetings of EMG-Biofeedback - assisted training Than the patients will be reevaluated after 6 and 12 weeks.
详细描述
- The Aim:
The aim of the study is to evaluate beneficial effects of biofeedback therapy in reducing pain, increased tension of masticatory muscles occurring in patients with myogenous TMD and if the therapy influences psychological and sleep parameters. Also to verify if the effect of the therapy persists in time. 2. Patients:
- Experimental group 1 - patients diagnosed with myalgia subjected to 4 EMG-Biofeedback trainings. The group will include approximately 20 adults.
- Experimental group 2 - patients diagnosed with myalgia subjected to 8 EMG-Biofeedback trainings. The group will include approximately 20 adults.
- Control group - patients diagnosed with myalgia subjected to physiotherapy (manual therapy), stabilization splint usage and counseling (20 adults).
- Methods:
Adult patients diagnosed with masticatory muscles myalgia will be included in this study. All participants will be evaluated in accordance to the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD). Intensity of pain in the masticatory muscles will be defined using the Numerical Rating Scale (NRS). The pressure pain threshold (PPT) will be assessed with an dolorimeter and noticed on DC/TMD pain drawing diagram. Each of the qualified patients will also undergo the electromyography of temporal and masseter muscles. All participants will fill in questionnaires (Graded Chronic Pain Scale (GCPS), Pittsburgh Sleep Quality Index (PSQI), Patient Health Questionnaire-9 (PHQ-9), Beck Anxiety Inventory (BAI) and Perceived Stress Scale-10 (PSS-10) and Somatic Symptom Scale-8 (SSS-8).
Patients qualified to the experimental groups will be divided in to 2 subgroups composed of 20 participants each.
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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of myalgia in accordance to Diagnostic Criteria for Temporomandibular Disorders
- •full dentition or single tooth loss
- •age between 18 and 70
排除标准
- •age under 18
- •age over 70
- •terminal general diseases
- •severe mental disorders
- •severe neurological disorders
- •intake of drugs affecting muscle function
- •edentulism or destruction of dentition
- •alcoholism
- •drug addiction
- •history of severe trauma in the head and neck region
- •severe pathology of temporomandibular joints
- •congenital or acquired craniofacial deformity
- •patients suffering from neuropathic pain
- •patients with craniofacial inflammation
- •patients undergoing orthodontic treatment
- •pregnancy
- •significant postural defect
结局指标
主要结局
The effect of EMG biofeedback therapy on pain symptoms measured by pressure pain threshold in Experimental group 2
时间窗: before the treatment, after 8 weeks of training
This effect will be assessed by comparing pressure pain threshold pre- and post- biofeedback therapy. Pressure pain threshold will be measured with dolorimeter.
The effect of EMG biofeedback therapy on pain symptoms measured by Numerical Rating Scale (NRS) in Experimental group 2
时间窗: before the treatment, after 8 weeks of training
This effect will be assessed by comparing Numerical Rating Scale (NRS) pre- and post- biofeedback therapy. A numerical rating scale (NRS) requires the patient to rate their pain on a scale 0-10, where 0 is no pain and 10 is the worst pain imaginable
The effect of EMG biofeedback therapy on pain symptoms measured by pressure pain threshold in Experimental group 1
时间窗: before the treatment, after 4 weeks of training
This effect will be assessed by comparing pressure pain threshold pre- and post- biofeedback therapy. Pressure pain threshold will be measured with dolorimeter.
The effect of EMG biofeedback therapy on pain symptoms measured by Numerical Rating Scale (NRS) in Experimental group 1
时间窗: before the treatment, after 4 weeks of training
This effect will be assessed by comparing Numerical Rating Scale (NRS) pre- and post- biofeedback therapy. A numerical rating scale (NRS) requires the patient to rate their pain on a scale 0-10, where 0 is no pain and 10 is the worst pain imaginable
次要结局
- Effect of EMG biofeedback therapy on psychological parameters and its persistence in time measured by Beck Anxiety Inventory (BAI).(before the treatment and up to 12 weeks after completion of the treatment)
- Effect of EMG biofeedback therapy on sleep quality and its persistence in time measured by Pittsburgh Sleep Quality Index (PSQI)(before the treatment and up to 12 weeks after completion of the treatment)
- Effectiveness of EMG biofeedback therapy on pain symptoms in comparison to "standard" treatment measured by Numerical Rating Scale (NRS)(after treatment and up to 12 weeks later)
- Effect of EMG biofeedback therapy on psychological parameters and its persistence in time measured by Patient Health Questionnaire-9 (PHQ-9)(before the treatment and up to 12 weeks after completion of the treatment)
- Effect of EMG biofeedback therapy on psychological parameters and its persistence in time measured by Perceived Stress Scale-10 (PSS-10)(before the treatment and up to 12 weeks after completion of the treatment)
- Effect of EMG biofeedback therapy on psychological parameters and its persistence in time measured by Somatic Symptom Scale-8 (SSS-8).(before the treatment and up to 12 weeks after completion of the treatment)
- Persistence in time of EMG biofeedback therapy effects on pain symptoms measured by Numerical Rating Scale (NRS)(after treatment and up to 12 weeks later)
- Persistence in time of EMG biofeedback therapy effects on pain symptoms measured by pressure pain threshold(after treatment and up to 12 weeks later)
- Effectiveness of EMG biofeedback therapy on pain symptoms in comparison to "standard" treatment measured by pressure pain threshold(after treatment and up to 12 weeks later)
研究者
Wojciech Florjański
Principal Investigator
Wroclaw Medical University