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临床试验/NCT02295644
NCT02295644已完成不适用

Immediate Effect of Ultrasound Therapy on Bilateral Masseter Myalgia: Randomized Single Blinded Investigational Trial

State University of New York at Buffalo1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2014年11月1日最近更新:
适应症
干预措施

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

Experimental

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

Experimental

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

Experimental

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

Experimental

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

W.D.McCall, Jr.

Professor

State University of New York at Buffalo

研究点 (1)

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