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临床试验/NCT04086862
NCT04086862已完成不适用

Effect of Ultrasound Therapy on Bilateral Masseter Myalgia: Comparison of 1 Megahertz Versus 3 Megahertz

State University of New York at Buffalo2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2019年10月24日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
25
试验地点
2
主要终点
Reduction in masseter pain by pressure pain threshold.

研究概览

简要总结

Temporomandibular disorders (TMD) are a group of musculoskeletal and neuromuscular conditions that involve the temporomandibular joints, the masticatory muscles, and all associated tissues. These disorders are characterized by regional pain and limitation of mandibular range of motion. Pain-related TMD affects approximately 5% to 12% of the population and can affect individual's quality of life. The incidence is about 4 percent. Therapeutic ultrasound is a type of physical therapy that delivers energy via propagation of ultrasonic waves. One gap in knowledge is whether 1 megahertz (MHz) treating frequency has the same efficacy as treating with 3 MHz. This research proposes to test that.

详细描述

See brief summary.

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, Care Provider)

盲法说明

The frequency setting on the ultrasound machine will be set and known only to the principal investigator.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Adult females
  • Bilateral myalgia based on Diagnostic Criteria for TMD (DC-TMD) criteria
  • An average pain of 5 or more on a 0 to 10 scale over the last 30 days.

排除标准

  • A history or diagnosis of systemic musculoskeletal disorders or rheumatologic diseases (e.g. fibromyalgia, muscular atrophy).
  • Certain conditions such as neoplasms or fractures.
  • Neuropathies or neurological disorders.
  • Currently taking muscle relaxants or analgesics.
  • Undergone any form of physical therapy within the last 60 days.
  • Severe bruxism requiring mouth-guard treatment.

结局指标

主要结局

Reduction in masseter pain by pressure pain threshold.

时间窗: Baseline to fifth week.

Reduction in masseter pain as measured with the pressure pain threshold (VAS). The VAS runs from 0 (no pain at all) to 100 (worst pain imaginable)..

Reduction in masseter pain by visual analog pain scale.

时间窗: Baseline to fifth week.

Reduction in masseter pain as measured on a visual analog scale (VAS). The VAS runs from 0 (no pain at all) to 100 (worst pain imaginable).

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 (2)

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