Immediate Effect of Irradiation With Low-level Laser Therapy on the Electromyographic Activity of the Upper Trapezius Muscles and the Level of Pain Among Patients With Non-specific Neck Pain: a Randomized, Double-blinded, Sham-controlled, Crossover Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Electromyographic activity
研究概览
简要总结
The aim of the present study is to assess the immediate effect of irradiation with low level laser therapy (LLLT) on the electromyographic activity of upper trapezius muscles and the amount of pain felt by patients with non-specific neck pain (NS-NP).A total of 20 patients with non-specific neck pain will be enrolled in a randomized, single-blind, crossover study. Each subject will receive two forms of treatment in random order: a single session of LLLT and placebo LLLT. In order to eliminate carry-over treatment effects, a one-week wash-out period will be respected between sessions. Surface electromyography will be used to determine nerve conduction velocity and activity in the upper trapezius muscles before and after treatment. The outcome measures will be determined by a numerical pain rating scale. Comparisons before and after irradiation with LLLT will determine the activity of the upper trapezius muscles and the level of pain. The data will be submitted to statistical tests considering a p-value of p < 0.05.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 to 40 years
- •Male and female volunteers
- •History of neck pain for a period of more than two months
- •Score ranging from 15 to 24 on the Neck Disability Index
- •Score ranging from three to seven points on an 11-point (range: 0 to 10) numerical rating scale (NRS) for perceived pain intensity
排除标准
- •history of neurological disorders
- •neck surgery
- •chronic neck pain resulting from a traumatic incident
- •chronic musculoskeletal condition
- •medical diagnosis of fibromyalgia; systemic disease
- •connective tissue disorder
- •having undergone physical therapy use of analgesic, muscle relaxant.
研究组 & 干预措施
Experimental: low level laser therapy (LLLT)
For the LLLT irradiation, a paper template with 9 points (area of 1cm and a distance from center to center of 1 cm) will be used, distributed in three columns and three lines. The central point of the template will be positioned above the medium point of a line traced between the acromion and the spinous process of the seventh cervical vertebra, where the treatment should be close to the fixation point of the EMG electrode. The application point of the LLLT was determined by the location of the innervation point of the upper trapezius muscle.
Individuals will be subject to application of low level laser with a total dose of 18 J
干预措施: low level laser therapy (Device)
Experimental: Placebo low level laser therapy (PLLLT)
For the PLLLT irradiation, a paper template with 9 points (area of 1cm and a distance from center to center of 1 cm) will be used, distributed in three columns and three lines. The central point of the template will be positioned above the medium point of a line traced between the acromion and the spinous process of the seventh cervical vertebra, where the treatment should be close to the fixation point of the EMG electrode. The application point of the PLLLT was determined by the location of the innervation point of the upper trapezius muscle.
Individuals will be subject to application of low level laser with a total dose of 0 J
干预措施: Placebo low level laser therapy (Device)
结局指标
主要结局
Electromyographic activity
时间窗: 1 Year
The EMG signal will be recorded in the dominant upper trapezius muscle in patients with nonspecific neck pain, will be evaluated before and after treatment.
次要结局
- Numerical rating scale score for pain(1 Year)
研究者
Prof. Fabiano Politti, FT
PhD
University of Nove de Julho