Effect of High-intensity Laser Therapy in Patients With Chronic Nonspecific Neck Pain. Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Pain intensity at movement (MPI)
研究概览
简要总结
Chronic nonspecific neck pain is a common musculoskeletal disorder recognized for its high rates of disability and economic losses, ranking second in musculoskeletal conditions after low back pain. There are several effective physical therapy interventions to treat chronic nonspecific neck pain, such as laser therapy. High-intensity laser therapy (HILT) is a recent treatment proposed to reduce musculoskeletal pain; however, there are few studies that prove its effects in reducing neck pain.
The aim of this randomized clinical trial is to evaluate the effect of high-intensity laser therapy on pain intensity in patients with chronic nonspecific neck pain.
The research will be carried out in the laboratory of physical agents at the Andrés Bello University, Campus Casona de las Condes. Participants will be employers and volunteer students with non-specific chronic neck pain. Participants will be randomized and allocated into 2 study groups: group 1 (HILT and stretching exercises) and group 2 (simulated HILT and stretching exercises). Treatments will be performed twice a week for 4 weeks with 3 assessments: before treatment, at the end of treatment, and 12 weeks after treatment (follow-up). The main results will be the differences in pain pressure threshold (ΔPPT), intensity of pain at rest (ΔRPI) and intensity of pain on movement (ΔMPI). Secondary outcome measures, on the other hand, will include differences in cervical spine range (ΔCROM) and cervical disability (ΔND).
详细描述
Material and Methods
Type of study: Experimental, randomized clinical trial (RCT).
- Study population:
For the study, students and employees of Andrés Bello University will be considered participants. 2. Randomization and sample:
Participants will be evaluated according to the selection criteria through a survey with closed questions and a clinical examination that will determine the presence or absence of chronic non-specific neck pain. Participants will be divided into two study groups through a simple randomization process: group 1 (HILT) and group 2 (sham HILT). The randomization of the sample will be carried out by the study director using the simple random sampling process through the research randomizer program, who will be the only one who knows the results. All groups will receive a treatment with an exercise plan that includes passive static stretching of the upper trapezius, levator scapulae, and scalenes muscles (three sets of 30 seconds for each group bilaterally). Participants will be scheduled twice a week for four weeks to carry out the assigned treatment.
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 must be at least 18 years old.
- •Both sexes (men and women)
- •Non-specific, chronic neck pain, defined as pain or discomfort in the cervical region between the superior nuchal line and the spinous process of T1 or the shoulder girdle, with the following criteria: neck pain in the last 3 months or more; a questionnaire score of cervical disability (NDI) equal to or greater than 5; and cervical pain of 3 or greater on the numerical pain scale (NPRS).
排除标准
- •Neck or shoulder musculoskeletal injuries in the last 3 months (fractures, sprains, tendinopathies, dislocations, or muscle tears).
- •Osteosynthesis materials close to the shoulders, neck, or surrounding areas.
- •Wounds or skin changes in the shoulder and/or neck region (such as psoriasis, scars, or burns).
- •Analgesic, anti-inflammatory, or muscle relaxant drugs for permanent use.
- •Neurological alterations such as paresthesia, loss of sensation (partial or complete), decrease in strength, or color changes in the neck, arms, forearms, or hands.
- •Diagnosed photosensitivity.
- •Presence of solar urticaria or adverse reactions to sunlight.
- •The presence of dermatomyositis, systemic lupus erythematosus, hepatic porphyria, cutaneous carcinoid syndrome, or pellagra.
- •Cancer or tumors of some type have been diagnosed in the last 5 years.
- •Epilepsy.
研究组 & 干预措施
HILT + stretching exercise
High-intensity laser therapy (HILT) will be applied with the punctual technique on the 6 bilateral points of the cervical region and shoulder girdle, to be followed by a sweep technique on both trapezius muscles (upper portions). The parameters proposed by Dundar et al. will be used: an average power of 3 W, 60 J per point (360 J), and 500 J for manual scanning (1000 J). For the application of laser therapy, the 12 W BTL-6000 equipment that emits at 1064 nm wavelengths will be used. Laser therapy will be applied with the participant in the prone position.The treatment will be complemented with passive static stretching for the upper trapezius, levator scapulae, and scalene muscles (bilaterally) in three series. Each series will last 30 seconds, followed by a 30-second rest interval. The exercises will be carried out with the participant in a seated position in a chair with a backrest.
干预措施: High-intensity laser therapy (Device)
HILT + stretching exercise
High-intensity laser therapy (HILT) will be applied with the punctual technique on the 6 bilateral points of the cervical region and shoulder girdle, to be followed by a sweep technique on both trapezius muscles (upper portions). The parameters proposed by Dundar et al. will be used: an average power of 3 W, 60 J per point (360 J), and 500 J for manual scanning (1000 J). For the application of laser therapy, the 12 W BTL-6000 equipment that emits at 1064 nm wavelengths will be used. Laser therapy will be applied with the participant in the prone position.The treatment will be complemented with passive static stretching for the upper trapezius, levator scapulae, and scalene muscles (bilaterally) in three series. Each series will last 30 seconds, followed by a 30-second rest interval. The exercises will be carried out with the participant in a seated position in a chair with a backrest.
干预措施: Stretching exercise (Procedure)
Sham HILT + stretching exercise
The group will receive a sham treatment of high-intensity laser therapy (HILT). The treatment will be complemented with passive static stretching for the upper trapezius, levator scapulae, and scalene muscles (bilaterally) in three series. Each series will last 30 seconds, followed by a 30-second rest interval. The exercises will be carried out with the participant in a seated position in a chair with a backrest.
干预措施: Stretching exercise (Procedure)
Sham HILT + stretching exercise
The group will receive a sham treatment of high-intensity laser therapy (HILT). The treatment will be complemented with passive static stretching for the upper trapezius, levator scapulae, and scalene muscles (bilaterally) in three series. Each series will last 30 seconds, followed by a 30-second rest interval. The exercises will be carried out with the participant in a seated position in a chair with a backrest.
干预措施: Sham High-intensity laser therapy (Device)
结局指标
主要结局
Pain intensity at movement (MPI)
时间窗: Baseline and 4 weeks (8 sessions)
Magnitude of pain reported by the participants when performing movements of the cervical spine in flexion, extension, inclination, and right and left rotation evaluated with visual anologue scale (VAS).
Pain pressure thereshold (PPT)
时间窗: Baseline, 4 weeks (8 sessions) and 12 weeks (follow-up)
Pain pressure threshold differences evaluated with algometry at six neck and shoulder locations: 2 cm lateral to the spinous processes of C2, C5, T4, and T8, midpoint of the upper trapezius muscle belly (between the spinous process of C7 and the acromion), and the levator scapula muscle (2 cm superior to the superior angle of the scapula).
Pain intensity at rest (RPI)
时间窗: Baseline, 4 weeks (8 sessions) and 12 weeks (follow-up)
Magnitude of neck pain reported by participants at rest evaluated with visual anologue scale (VAS)
次要结局
- Cervical range of motion (CROM)(Baseline and 4 weeks (8 sessions))
- Neck disability (ND)(Baseline and 4 weeks (8 sessions))
研究者
Hernán Andrés de la Barra Ortiz
Professor
Universidad Nacional Andres Bello