Immediate Effect of Ultrasound Therapy on Bilateral Masseter Myalgia: A Randomized Double Blinded Investigational Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Pressure pain threshold, change from pre- to post-ultrasound dose.
研究概览
简要总结
This study will compare ultrasound 0.4 W/cm^2 and 100% duty cycle versus no ultrasound (placebo) for bilateral masseter myalgia in up to 38 adult women. The dose will be applied for 5 minutes on each side. Both the dose and the starting side will be randomized. Both the subject and ultrasound operator will be blind to the dose. The outcome measures will be pressure pain threshold on both masseter muscles and both temporalis muscles, self reported pain scale (0, no pain to 10, worst pain ever), thermographic temperature of the muscles, and intraoral temperature. These outcome measures will be taken before and after each dose, so three times per subject.
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)
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 Bilateral myalgia based on Diagnostic Criteria for TMD (DC-TMD) (Schiffman, et al., 2014) 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
- •History or diagnosis of systemic musculoskeletal disorders. Rheumatologic diseases (e.g. fibromyalgia, muscular atrophy). Certain conditions such as neoplasms or fractures. Neuropathies or neurological disorders. Currently taking muscle relaxants or analgesics. Any form of physical therapy within the last 60 days.
结局指标
主要结局
Pressure pain threshold, change from pre- to post-ultrasound dose.
时间窗: Immediate. Data taken before and after each dose, so three times in the one session which lasts about one hour to completion..
The change in pressure pain threshold from before to after the ultrasound (or placebo) will be averaged over the two masseter muscles, and over the two temporalis muscles.
Self reported pain scale, change from pre- to post-ultrasound dose which lasts about one hour to completion.
时间窗: Immediate. Data taken before and after each dose, so three times in the one session.
The change in self reported pain scale from before to after the ultrasound (or placebo) will be averaged over the two masseter muscles, and over the two temporalis muscles.
Intraoral temperature
时间窗: Immediate. Data taken before and after each dose, so three times in the one session which lasts about one hour to completion.
The intraoral temperature in the buccal area near the masseter muscle will be recorded before and after the ultrasound
Thermographic temperature of the muscles
时间窗: Immediate. Data taken before and after each dose, so three times in the one session which lasts about one hour to completion.
The thermographic temperature of each masseter and each temporalis muscle will be recorded before and after the ultrasound.
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