Effectiveness of High Intensity Laser Therapy (HILT) and Stretching Exercises on Cervical Flexibility and Pain Reduction in Myofascial Trigger Points. Randomized Clinical Trial (RCT).
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Pain pressure thereshold (PPT)
研究概览
简要总结
The aim of the study is to evaluate the effects of HILT on cervical flexibility and pain reduction in myofascial trigger points. The research will be carried out in the Physiotherapy laboratory of Andrés Bello University. The participants will be civil servants and volunteer university students with the presence of latent MTrPs of the upper trapezius muscle. Participants will be randomized and divided into 3 study groups: group 1 (HILT and stretching exercises), group 2 (sham HILT and stretching exercises), and group 3 (the conventional US and stretching exercises). The treatments will be carried out twice a week for 4 weeks accompanied by 2 evaluations during the treatment and 1 post-treatment follow-up. The main result will be considered the differences in pain intensity (ΔPI), pain pressure threshold (ΔPPT), cervical spine range (ΔCROM), and cervical disability (ΔND) between the evaluation sessions.
详细描述
Material and Methods
Type of study: Experimental, randomized clinical trial (RCT).
1. Study population.
For the study, students and workers of Andrés Bello University will be considered participants.
2 Randomization and sample.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants over 18 years of age.
- •Officials and students of the Casona las Condes Campus of the Andrés Bello University.
- •Presence of myofascial trigger points in the shortened upper trapezius muscle evaluated (expert consensus establishing criteria for the diagnosis of MTrPs, Delphi study).25
排除标准
- •Musculoskeletal problems or pathologies of the neck or shoulders in the last 3 months (fractures, sprains, tendinopathies, dislocations, or muscle tears).
- •Presence of osteosynthesis materials near shoulders, neck, or surrounding areas.
- •Presence of wounds or skin changes in the shoulder and/or neck region (such as psoriasis, scars, or burns).
- •Use of analgesic, anti-inflammatory, or muscle relaxant medications for permanent use.
- •Neurological changes such as paresthesia, loss of sensitivity (partial or complete), decreased strength, and color changes in the neck, arms, forearms, or hands.
- •Diagnosed photosensitivity.
- •Presence of solar urticaria or adverse reactions to sunlight.
- •Presence of the following conditions: dermatomyositis, systemic lupus erythematosus, hepatic porphyria, cutaneous carcinoid syndrome or pellagra
- •Cancer or tumors of any type diagnosed.
- •Epilepsy.
研究组 & 干预措施
Experimental group 1 (HILT + stretching exercise)
The group will receive treatment of high-intensity laser therapy (HILT) with a total energy delivery of 1,060J divided into 3 phases will be achieved: phase 1, 500J; phase 2, 60J; phase 3, 500J. It will work with an average power of 3W and an energy density of 50J/cm2. At the end of the assigned treatment will be added a treatment protocol of upper trapezius stretching exercises for the evaluated limb with shortening. The stretches will consist of 4 series of 30 seconds with an interval of 30 seconds between series.
干预措施: High intensity laser therapy (HILT) (Device)
Experimental group 1 (HILT + stretching exercise)
The group will receive treatment of high-intensity laser therapy (HILT) with a total energy delivery of 1,060J divided into 3 phases will be achieved: phase 1, 500J; phase 2, 60J; phase 3, 500J. It will work with an average power of 3W and an energy density of 50J/cm2. At the end of the assigned treatment will be added a treatment protocol of upper trapezius stretching exercises for the evaluated limb with shortening. The stretches will consist of 4 series of 30 seconds with an interval of 30 seconds between series.
干预措施: Stretching exercise (Procedure)
Experimental group 2 (Sham HILT + stretching exercise)
The group will receive a sham treatment of high-intensity laser therapy (HILT). At the end of the assigned treatment will be added a treatment protocol of upper trapezius stretching exercises for the evaluated limb with shortening. The stretches will consist of 4 series of 30 seconds with an interval of 30 seconds between series.
干预措施: High intensity laser therapy (HILT) (Device)
Experimental group 2 (Sham HILT + stretching exercise)
The group will receive a sham treatment of high-intensity laser therapy (HILT). At the end of the assigned treatment will be added a treatment protocol of upper trapezius stretching exercises for the evaluated limb with shortening. The stretches will consist of 4 series of 30 seconds with an interval of 30 seconds between series.
干预措施: Stretching exercise (Procedure)
Experimental group 3 (US + stretching exercise)
The group will receive treatment of therapeutic ultrasound. The US parameters will be programmed with a frequency of 1MHz, the intensity of 1.5 W/cm2, the Duty cycle of 100%, an ERA of 5cm2, and a time of 6 minutes. At the end of the assigned treatment will be added a treatment protocol of upper trapezius stretching exercises for the evaluated limb with shortening. The stretches will consist of 4 series of 30 seconds with an interval of 30 seconds between series.
干预措施: Therapeutic Ultrasound (US) (Device)
Experimental group 3 (US + stretching exercise)
The group will receive treatment of therapeutic ultrasound. The US parameters will be programmed with a frequency of 1MHz, the intensity of 1.5 W/cm2, the Duty cycle of 100%, an ERA of 5cm2, and a time of 6 minutes. At the end of the assigned treatment will be added a treatment protocol of upper trapezius stretching exercises for the evaluated limb with shortening. The stretches will consist of 4 series of 30 seconds with an interval of 30 seconds between series.
干预措施: Stretching exercise (Procedure)
结局指标
主要结局
Pain pressure thereshold (PPT)
时间窗: Change from Baseline pain pressure thereshold at eight treatment sessions.
Comparing pain pressure threshold differences on trigger point of trapezius muscle for pre and post-treatment protocol.
Joint Range changes (CFROM)
时间窗: Change from Baseline joint range changes at eight treatment sessions.
Comparing maximum cervical range differences for pre and post for pre and post-treatment protocol.
次要结局
- Neck disability(Change from Baseline meck disability at eight treatment sessions.)