Comparing the Effect of Typical Electrical Stimulation Therapy With Nocipoint Stimulation Therapy on TMD-Related Myofascial Pain
试验速览
- 阶段
- 不适用
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Visual Analog Scale (VAS) for pain
研究概览
简要总结
The purpose of this study is to measure the effect of nocipoint therapy on patients with temporomandibular joint disorders (TMD) and compare it with the effect of standard electrical stimulation therapy.
详细描述
The prevalence of temporomandibular disorders (TMD) is about 20% to 60% of dental patients. Most patients suffer from myofascial pain (MFP) subtype of TMD. Analgesics, local muscle injection or oral appliance are often used to treat TMD-related MFP. Patients are also referred to physical therapists frequently. Many physical therapy (PT) modalities and techniques are applied to these patients, including non-invasive transcutaneous electrical nerve stimulation (TENS) using TENS devices. However, the exact application of TENS devices, including the location of the stimulation, duration and intensity of stimulation, is largely decided by physical therapists. Nocipoint Therapy, a unique combination of precise location, duration and intensity of TENS has been found to substantially relieve general myofascial pain and recover the muscle function with lasting effect.
In preliminary observations of clinical applications, Nocipoint Therapy has been found to rapidly and substantially relieve TMD-related MFP within 2-3 sessions of the treatment.
This clinical study compares the effect of Nocipoint Therapy on TMD with that of standard Physical therapy (PT). TENS will be used in the control group both as a part of the standard of care (i.e., PT) and as placebo.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •20-65 years old female or male
- •Diagnosed as MFP subtype of TMD according to RDC/TMD
- •Pain duration over 3 month
- •Tender point in masseter
- •Asymmetrical pain intensity
- •Subsided symptoms of joint inflammation
排除标准
- •Traumatic TMD from external impact force
- •History of traumatic cervical injury
- •Presence of systemic disease
- •Fibromyalgia
- •Co-interventions for cervical problems or TMD during study period
- •Signs of psychosomatic illness
- •Unwilling to be randomized
结局指标
主要结局
Visual Analog Scale (VAS) for pain
时间窗: Measurements will be taken before and after each session, and at the follow-up, which is about 4 to 6 weeks after the last session
VAS is measured before each treatment session and at the follow-up: 1. VAS - overall 2. VAS - most painful 3. VAS - when biting hard food 4. VAS - at maximal mouth opening range (MMO) 5. VAS of pressure pain- measured at the three most painful pressure points. 1,2, and 5 are also measured after each treatment session.
次要结局
- Maximal mouth opening range (MMO)(Measurements will be taken before and after each session, and at the follow-up, which is about 4 to 6 weeks after the last session)
- Quality of Life (QoL)(Measurements will be taken before the first session and at the follow-up.)