JPRN-jRCTs032230628招募中Unknown
Exploratory study on usefulness of bio-electrical patch for masticatory muscle pain disorder in patient with temporomandibular joint disorder
Hoshi Kazuto0 个研究点目标入组 20 人开始时间: 2024年2月13日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 < 65age old（—）
- 性别
- All
入选标准
- •The following selection criteria will be applied to those who meet all of the following criteria.
- •(1) Those who have received a diagnosis of masticatory muscle pain of Temporomandibular joint disorders (Diagnostic Criteria for TMJ Disorders (2020))
- •(2) Persons who are able to manage and affix the device at home and fill out the recording form
- •(3) Age: Persons who are between 18 and 65 years old at the time of obtaining consent
- •(4) Gender: Any gender
- •(5) Those who have no difficulty in Japanese language proficiency for participation in the research..
- •(6) Persons who have received a full explanation of their participation in this research, and who have given their free and voluntary written consent based on a full understanding of the subject matter.
- •(7) Those who are able to make outpatient visits in accordance with the research schedule.
排除标准
- •Patients who meet at least one of the following exclusion criteria will be excluded.
- •(1) Patients with intracranial diseases such as cerebro-medullary hypovolemia or musculoskeletal diseases such as muscular dystrophy, as well as diseases or disorders with open mouth disorder that require differentiation from temporomandibular joint disorder.
- •(2) Patients taking anti-inflammatory analgesics, central muscle relaxants, antidepressants, sleep inducing drugs, etc. within 1 month prior to obtaining consent
- •(3) Patients who have received intramuscular injection for mastication muscle pain within 1 month prior to obtaining consent
- •(4) Patients who have undergone physical therapy such as appliance therapy, occlusion therapy, electric stimulation therapy, heat therapy, and massage as basic treatment for TMJ arthrosis within one month prior to obtaining consent.
- •(5) Patients with a history of TMJ surgical treatment (TMJ pumping therapy, TMJ arthroscopic surgery, open TMJ surgery, masseter muscle tendonectomy, etc.) in the past.
- •(6) Patients with a history of alcoholism or drug addiction
- •(7) Patients with serious neurological or psychiatric diseases such as cerebrovascular disease, brain tumor, schizophrenia, epilepsy, normal pressure hydrocephalus, mental retardation, head injury with loss of consciousness, history of brain surgery with residual defect
- •(8) Persons using medical electrical devices implanted in the body that are susceptible to electromagnetic interference, such as pacemakers, implantable cardioverter-defibrillators, etc.
- •(9) Persons who have metal coils implanted intracranially
- •(10) Patients with serious or poorly controlled diseases at the time of consent, such as blindness, deafness, aphasia, etc.
- •(11) Patients who have participated in other clinical research or clinical trials within 3 months prior to obtaining consent
- •(12) Patients whose treatment for dental disease has not been completed
- •(13) Persons with a history of dermatitis caused by compresses or tapes
- •(14) Persons with bleeding, lacerations or abrasions, puncture wounds, injuries, inflammation, venous irritation or other abnormalities on the skin at the site of patch application
- •(15) Persons with a high fever 38 degrees or higher
- •(16) Others who are deemed inappropriate by the investigator.
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