Evaluating the Safety and Efficacy of the BTL-043 and BTL-785F Devices in Alleviating Temporomandibular Joint (TMJ) Pain
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 48
- 试验地点
- 4
研究概览
简要总结
This prospective, multi-center, open-label, single-arm clinical study will evaluate the efficacy and performance of the BTL-043 and BTL-785F devices for alleviating TMJ pain. Up to 60 subjects will undergo four treatment visits, administered 2-10 days apart, followed by 1-month and 3-month follow-up visits. During a single treatment session at each visit, subjects will receive consecutive treatment with both devices. At baseline, informed consent, eligibility assessment, Fitzpatrick phototype evaluation, TMD Disability Index, VAS, weight and height measurements, 2D mandibular ROM photographs, and mandibular/lateral ROM assessments will be completed. A urine pregnancy test will be performed prior to each treatment visit. After the final treatment, subjects will complete the TCQ, SSQ & QoL, TMD Disability Index, and VAS, and repeat all physical assessments. At both follow-up visits, subjects will complete the SSQ & QoL, TMD Disability Index, and VAS, and repeat the physical assessments. Safety will be evaluated through documentation and assessment of adverse events at each treatment and follow-up visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 22 years and older
- •Voluntarily signed an informed consent form
- •Subject is willing to comply with study instructions, to return to the clinic for the required visits
- •Willingness to adhere to and continue current pain management plan
- •Subjects willing and able to maintain their regular (pre-procedure) diet, exercise and therapy regimen without significant change during study participation
- •Subject is willing and able to abstain from partaking in any new treatments other than this study procedure to treat TMJ pain
- •Women of child-bearing potential* are required to use birth control measures during the whole duration of the study
- •Women of childbearing potential are defined as any female who has experienced menarche and who is NOT permanently sterile or postmenopausal. Postmenopausal is defined as 12 consecutive months with no menses without an alternative medical cause.
排除标准
- •Major systemic diseases - e.g., uncontrolled Diabetes mellitus, systemic lupus erythematosus
- •Current pregnancy, nursing, or IVF procedure
- •Photosensitivity, medications affecting sensitivity to light
- •Tattoos or other higher pigmented regions in the treated area
- •Corticosteroids or injections of the treated area within the last 3 months, long-term corticosteroids use
- •Anticoagulant therapy, bleeding disorders
- •Hemorrhage in the treated area
- •Application over the thyroid or other endocrine glands
- •Subjects currently undergoing, or who have received, radiation therapy or chemotherapy within the past 6 months prior to study treatment
- •Known or suspected malignancy, history of cancer, any type of malignancy or pre-malignant moles
- •Febrile conditions, serious illness, chronic infection
- •Neurological disorders (such as multiple cerebrospinal sclerosis, epilepsy)
- •Sensory or sensitivity disorders in the treatment area
- •Active bacterial or viral infection, acute inflammation
- •Impaired immune system
- •Isotretinoin in the past 12 months
- •Skin-related autoimmune diseases
- •Poor healing and unhealed wounds in the treatment area
- •Metal implants near the treatment area or neutral electrode
- •Permanent implant near the treatment area
- •Pacemaker or internal defibrillator, or any other active electrical implant, anywhere in the body
- •Active collagen diseases
- •Cardiovascular diseases (such as vascular diseases, peripheral arterial disease, thrombophlebitis and thrombosis)
- •Any active condition in the treatment area, such as sores, psoriasis, eczema, rash and rosacea
- •Any surgical procedure in the treatment area within the last three months or before complete healing
- •Tuberculosis
- •Hepatitis
- •Poorly controlled endocrine disorders
- •History of bleeding coagulopathies
- •Acute neuralgia and neuropathy
- •Kidney or liver failure
- •Skin dermabrasion, skin resurfacing, or deep chemical peeling in the treatment area within 3 months prior to the treatment
- •Electroanalgesia without exact diagnose of pain etiology
- •Serious psychopathological disorders (such as schizophrenia)
- •Inflammation of blood or lymphatic vessels
- •Scarring in the treatment area
- •Swollen, infected, or inflamed areas or damaged skin, skin eruptions, e.g., phlebitis, thrombophlebitis, varicose veins, etc.
- •Hypersensitive carotid sinus
研究组 & 干预措施
Treatment with BTL-043 and BTL-785F device
干预措施: Treatment with BTL-043 and BTL-785F (Device)