Immediate Effect of Ultrasound Therapy on Bilateral Masseter Myalgia: Randomized Single Blinded Investigational Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Self Report of Pain
研究概览
简要总结
Introduction. Temporomandibular disorders (TMD) are a group of conditions that are multifactorial in nature, and it primarily presents with symptoms of pain and decreased functional capacity. Therapeutic ultrasound is a method of physical therapy that has shown clinically to provide immediate relief of pain in patients with different musculoskeletal disorders. In this study, for the purpose of immediate management of painful masticatory muscle and tissues, the investigators attempt to understand the mechanism of therapeutic ultrasound by exploring the physiologic changes peripherally and centrally. In addition, the investigators aim to determine if there is a dose response relationship between two different intensities (0.4 W/cm2 and 0.8 W/cm2) and between two sets of duty cycles (50% and 100%). A third purpose is to determine if therapeutic ultrasound applied to the masseter muscle is capable of eliciting segmental effects in the temporalis muscle. Methods. A total of 28 adult females with bilateral myalgia according to Diagnostic criteria for TMD (DC/TMD) will be recruited for this investigational trial. Each subject will be randomly allocated to one of the four ultrasound intervention groups each of which has different settings. Using Sonicator®740, therapeutic ultrasound intervention will be performed on both masseters for five minutes on each side of the face. A template will be used to confine the borders of the muscle and to determine the sites for the repeated outcome measures. Outcome parameters of: self-reported pain scale, pressure pain threshold, electromyographic muscle amplitudes and intraoral muscle temperatures will be measured for masseter and temporalis muscles on each side of the face, and will be assessed at baseline and after intervention on each side.
详细描述
The "Brief Summary" above encompasses the detailed description.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult females who have bilateral myalgia based on Diagnostic Criteria for TMD (DC-TMD) criteria and current pain intensity (≥4 out of 10, where 0 is no pain and 10 is the worst pain ever) on both sides.
排除标准
- •Those who have a history or were diagnosed with systemic musculoskeletal disorders or rheumatologic diseases (e.g. fibromyalgia, muscular atrophy).
- •Certain conditions such as neoplasms or fractures.
- •Neuropathies or neurological disorders.
- •Participants who are currently taking muscle relaxants or analgesics.
- •Those who have undergone any form of physical therapy within the last 60 days.
研究组 & 干预措施
A: 0.4 Watts/Sq cm 50% Duty cycle
0.4 Watts/Sq cm 50% Duty cycle Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1 (MegaHertz) MHz, 5 minutes
干预措施: Ultrasound Sonicator 740 (Device)
B: 0.4 Watts/Sq cm 100% Duty cycle
0.4 Watts/Sq cm 100% Duty cycle Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1 MHz, 5 minutes
干预措施: Ultrasound Sonicator 740 (Device)
C: 0.8 Watts/Sq cm 50% Duty cycle
0.8 Watts/Sq cm 50% Duty cycle Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1 MHz, 5 minutes
干预措施: Ultrasound Sonicator 740 (Device)
D: 0.8 Watts/Sq cm 100% Duty cycle
0.8 Watts/Sq cm 100% Duty cycle Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1 MHz, 5 minutes
干预措施: Ultrasound Sonicator 740 (Device)
结局指标
主要结局
Self Report of Pain
时间窗: Immediately before and after the intervention, difference used.
Pain intensity measurement scale from 0 to 10, 0 is no pain, 10 is the worst pain ever
Intraoral Muscle Temperature
时间窗: Immediately before and after the intervention, difference used.
Using digital thermometer on buccal mucosa, degrees celsius.
Pressure Pain Threshold of the Masseter Muscle
时间窗: Immediately before and after the intervention, difference used.
Measuring pressure pain threshold using digital algometer
次要结局
未报告次要终点
研究者
W.D.McCall, Jr.
Professor
State University of New York at Buffalo
