Transcutaneous Mandibular Nerve Electrical Stimulation for the Management of Pain and Function in Patients With Temporomandibular Disorders
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- pain intensity
研究概览
简要总结
Temporomandibular disorders (TMD) encompass dysfunction and pain of the masticatory muscles and temporomandibular joint (TMJ). Pain in the TMJ, restricted jaw movement, and joint sounds are common conditions in this disorder. This can impact patients' ability to perform daily activities such as eating, speaking, laughing, or yawning, significantly affecting their quality of life.
The TMJ and masticatory muscles are innervated by the auriculotemporal branch and the mandibular nerve (V3), a branch of the trigeminal nerve. An estimated 60% to 70% of the population shows signs of TMD, of which up to 12% report intense symptoms requiring treatment.
Percutaneous electrical nerve stimulation (PENS) could be a clinically relevant therapy in TMD patients applied through minimally invasive physiotherapy. To our knowledge, there are no trials evaluating the non-surgical clinical efficacy of PENS on the mandibular nerve.
The project's objective is to assess the effectiveness of PENS on the mandibular nerve in this type of condition.
详细描述
Pain is the most common and limiting feature of Temporomandibular Disorders (TMD), affecting approximately 75% of the population at some point in life. These disorders involve dysfunction and pain in the masticatory muscles and temporomandibular joint, impacting patients' quality of life. An estimated 60-70% of the population shows signs of TMD, with up to 12% requiring treatment. The peak incidence occurs between 20 and 40 years, predominantly affecting women (8:1 compared to men).
Temporomandibular Disorder often coexists with other medical conditions, such as headaches. The most common diagnoses are myofascial pain, followed by disc displacement with reduction and arthralgia. Prevalence ranges from 3% to 15%, with new case rates between 2% and 4%. Prognosis for myofascial TMD varies, with studies indicating persistence, remission, and relapse.
The economic cost associated with TMD is significant, with studies revealing considerable expenses on treatments. The multifactorial pathophysiology of myofascial pain is influenced by bruxism, stress, psychological conditions, and fibromyalgia. Risk factors include genetics, psychological stress, and parafunctional habits. Clinical manifestations include pain, decreased jaw mobility, and additional symptoms in the head and neck. Diagnosis involves physical examination, palpation of muscles and joints, and imaging tests such as magnetic resonance imaging. Specific diagnostic criteria have been proposed.
Conservative treatment, including physiotherapy, manual therapy, exercises, splints, and pharmacological modalities, is the primary option. However, there are limitations in the effectiveness of some approaches. Physiotherapy is considered effective by 72% of respondents in the United Kingdom.
The musculoskeletal system related to the temporomandibular joint (TMJ) consists of masticatory, facial expression, and neck muscles, playing specific roles in jaw movement. Elevator muscles (masseter, temporal, and medial pterygoid) close the mouth, depressors (digastric and lateral pterygoid) open it, protractors (temporal and lateral pterygoid) move it forward, and retractors (masseter and medial pterygoid) move it backward. Facial expression and neck muscles contribute to additional functions.
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)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with local myofascial pain and/or increased tension in the masticatory muscles.
- •Patients with myofascial pain from temporomandibular disorder (TMD) at the time, diagnosed according to the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD).
- •Absence of temporomandibular disc displacement with or without reduction.
- •Pain in the masticatory muscles associated with limited mouth opening (<40mm).
- •Good general health (absence of chronic diseases that may affect the temporomandibular joint or masticatory muscles).
- •Written consent to participate in the study.
排除标准
- •Injury to the face or head during the research participation.
- •Undergone surgical procedures performed in the craniocervical region and degenerative neurological diseases.
- •Sudden illness of the patient that prevented participation in the study.
- •Will to end participation in the study.
- •Less than 2 weeks of evolution.
- •Inability to understand instructions or sign the informed consent.
- •Minor patients.
- •Regular medication, such as muscle relaxants, anticonvulsants, antidepressants, or anxiolytics
- •Facial paralysis.
- •Presenting a disease or infectious/inflammatory process of dental origin.
研究组 & 干预措施
Experimental Group
Manual Therapy, exercise and percutaneous electrical nerve stimulation.
干预措施: Percutaneous nerve stimulation (Procedure)
Experimental Group
Manual Therapy, exercise and percutaneous electrical nerve stimulation.
干预措施: Manual therapy (Other)
Experimental Group
Manual Therapy, exercise and percutaneous electrical nerve stimulation.
干预措施: exercise (Other)
Control Group
Manual Therapy, exercise.
干预措施: Manual therapy (Other)
Control Group
Manual Therapy, exercise.
干预措施: exercise (Other)
结局指标
主要结局
pain intensity
时间窗: At the beginning of each intervention session and one month after the end of the last intervention.
Numerical Pain Rating Scale (NPRS) (Appendix 2). Pain at rest and with chewing on a visual analogue scale. The minimum value is 0, and the maximum is 10. Higher values indicate more pain.
Pressure pain thresholds (PPT)
时间窗: At the beginning of each intervention session and one month after the end of the last intervention.
A pressure algometer (kg/cm2) will be used. The measurement will be taken with which the minimum amount of pressure applied to the masseter muscle produces pain.
Pain-free mandibular opening range of motion
时间窗: At the beginning of each intervention session and one month after the end of the last intervention.
herabite® System ruler (Appendix 3). 6 mm has been determined as the minimum detectable change in maximum mouth opening \[56\]. Mandibular range of motion (maximum mouth opening) will be measured with a device that allows the evaluation of mouth movements in millimeters.
次要结局
- Self-reported quality of life (SF-12)(At the beginning of the first intervention and one month after the last intervention.)
- Electromyographic activation rate of the masseter muscle.(At the beginning of the first intervention and one month after the last intervention.)
研究者
Hector Mardomingo Medialdea
Director
OrigenKinesis fisioterapia