New Generation Low Level Laser Effect on Masseter Muscle Oxygenation, Bite Force and Algometric Changes in Myofacial Pain Syndrome: A Randomised, Placebo-controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- change from baseline in pain on the 10 point visual analogue scale (VAS) at week 3
研究概览
简要总结
Low level laser treatments have been used to treat painful trigger points in myofascial pain syndrome (MPS), but the effectiveness of the appropriate laser type and parameters is still uncertain. The aim of this study was to compare the effectiveness of different types of low level laser treatment (LLLT) in reducing pain levels, changing oxygen saturation and bite force in patients with MPS.
详细描述
A total of 45 patients with MPS were randomly divided into three groups. First group received LLLT with GRR laser over massater muscle region. Patients in the second group were treated with Nd:YAG laser and the same protocol with Nd:YAG laser was performed in the placebo group using sham device. Pain was evaluated by visual analogue scale (VAS), change in oxygen concentration in the massater muscle was measured by functional near-infrared spectroscopy- fNIRS and bite force was measured with Flexiforce sensors before and after treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients with symptoms of temporomandibular disorders and diagnosed with MPS as a result of the clinical examination.
排除标准
- •Patients with internal TMJ irregularities or degenerative joint changes,
- •patients with restricted mouth opening, deviation or deflection,
- •patients with systemic diseases,
- •pregnant women,
- •patients who had received MPS treatment within the previous year
结局指标
主要结局
change from baseline in pain on the 10 point visual analogue scale (VAS) at week 3
时间窗: baseline and week 3
Patients were asked to rate the intensity of their pain on a scale from 0 to 10. They were told that a score of 0 meant no pain, a score of 10 meant severe pain and a score of 5 meant moderate pain
change from baseline in oxygen concentration in the massater muscle at week 3
时间窗: baseline and week 3
oxygen concentration in the massater muscle was measured by functional near-infrared spectroscopy- fNIRS (ARGES cerebro, Hemosoft Inc., Ankara, Turkey) before and after treatment for each patient.
change from baseline in bite force values at week 3
时间窗: baseline and week 3
bite force values were recorded by Flexiforce sensors before and after treatment for each patient.
次要结局
未报告次要终点
研究者
İREM KARAGOZOGLU
Assist. Prof.
University of Gaziantep