Photobiomodulation Therapy and Transcutaneous Electrical Nerve Stimulation on Chronic Neck Pain Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 144
- 试验地点
- 2
- 主要终点
- Pain intensity: Numerical Rating Scale (Pain NRS)
研究概览
简要总结
This study evaluates the efficacy isolated and combinaded of photobiomodulation therapy with low level laser therapy and the transcutaneous electrical nerve stimulation.
详细描述
Non-specific chronic neck pain patients will be treated with low-level laser therapy and/or trancutaneous electricam nerve stimulation. They will receive 10 sessions of treatment. Before and after the treatment physical measures and psychosocial factors will be evaluted to verificy the efficay these electrophysical agents.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with non-specific chronic neck pain, defined as pain or discomfort in the posterior cervical region between the superior nuchal line and the first thoracic spinous process and / or shoulder girdle;
- •Neck pain for at least 3 months;
- •Neck Disability Index (NDI) score of 5 points or higher;
- •Numeric Rating Scale (NRS) score of 3 or higher to pain intensity;
- •Aged between 18 and 65 years;
- •Men and women
排除标准
- •Neck pain associated with nerve root compromise (measured by clinical examination of dermatomes, myotomes and reflexes);
- •Previous spinal surgery;
- •Patients treated with physical therapy for neck pain in the last 3 months previous the study;
- •Severe spinal disorders such as fractures, tumors, inflammatory and infectious diseases;
- •Any contraindication to low level laser therapy or transcutaneous electrical nerve stimulation;
- •Rheumatic, metabolic, neurological or cardiopulmonary diseases;
- •Patients who require artificial cardiac pacemakers;
- •Skin diseases, mainly at the current application site;
- •Tumors or cancer historic in the last 5 years;
- •Pregnancy;
- •If the patient started any physical activity in the last 2 weeks.
结局指标
主要结局
Pain intensity: Numerical Rating Scale (Pain NRS)
时间窗: 2 weeks after randomization
Pain intensity will be evaluated using an 11-point (0-10) Numerical Rating Scale (Pain NRS), which is a simple and easy-to-use measuring scale that consists of a sequence of numbers from zero to 10, in which zero represents "no pain" and 10 represents "the worst pain imaginable". The pain evaluation will be carried out verbally with the patient reporting the pain intensity.
次要结局
- Neck disability(2 weeks after randomization)
- Cervical range of motion(2 weeks after randomization)
- Pain catastrophizing(2 weeks after randomization)
- Pain intensity: Numerical Rating Scale (Pain NRS)(6 weeks after randomization)
- Pressure Pain Threshold(2 weeks after randomization)
- Global perceived effect (GPE)(2 weeks and 6 weeks after randomization)
- Conditioned pain modulation (CPM)(2 weeks after randomization)
- Depressive symptoms(2 weeks after randomization)
- Change in patient perception of quality of life:12-Item Short-Form Health Survey (SF-12)(2 weeks after randomization)
- Pain intensity at movement: Numerical Rating Scale (Pain NRS)(2 weeks after randomization)
- Analgesic intake(2 weeks after randomization)
- Pain temporal summation (TS)(2 weeks after randomization)
研究者
Richard Eloin Liebano
Professor
Universidade Federal de Sao Carlos