Effects of Photobiomodulation Therapy in Patients With Chronic Non-specific Low Back Pain: a Randomized Placebo-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 148
- 试验地点
- 2
- 主要终点
- Disability
研究概览
简要总结
Photobiomodulation therapy (PBMT) is a non-pharmacological method commonly used in treatment of musculoskeletal disorders. However, there are few high-quality scientific evidence to support the effectiveness of this therapy in the treatment of patients with chronic low back pain, at short, medium and long term. The present research project aims to evaluate the effects of PBMT in patients with chronic non-specific low back pain.
详细描述
This is a randomized, triple-blinded, placebo-controlled trial, with voluntary patients with chronic non-specific low back pain.One hundred and forty-eight patients will be randomly allocated to two treatment groups: Placebo or PBMT for 4 weeks (3 times per week, total of 12 sessions of 27 minutes each). The clinical outcomes will be obtained at the completion of treatment (4 weeks) and at 3, 6 and 12 months after randomization. The data will be collected by a blinded assessor. The statistical analysis will follow the intention-to-treat principles and the between-group differences will be calculated by using mixed linear models.
The outcomes of interest are pain intensity, disability, function and global perceived effect.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The mode of intervention (active or placebo photobiomodulation) will be coded by an independent researcher. The randomization schedule will contain only codes (not the actual intervention). The output from the laser device is exactly the same from either the active or the placebo interventions. These features will guarantee that participants, therapists and outcomes assessor will be blinded to the treatment arms.
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 seeking care for chronic non-specific low back pain (defined as pain or discomfort between the costal margins and the inferior gluteal folds, with or without referred symptoms in the lower limbs, for at least 3 month);
- •with a pain intensity of at least 3 points measured by a 0-10 points pain numerical rating scale;
- •aged between 18 and 65 years;
- •able to read Portuguese.
排除标准
- •evidence of nerve root compromise (i.e. one or more of motor, reflex or sensation deficit);
- •serious spinal pathology (such as fracture, tumor, inflammatory and infectious diseases);
- •serious cardiovascular and metabolic diseases;
- •previous back surgery;
- •pregnancy.
结局指标
主要结局
Disability
时间窗: 4 weeks after randomization
Disability will be measured by the 24-item Roland Morris Disability Questionnaire
Pain Intensity
时间窗: 4 weeks after randomization
Pain intensity will be measured by an 11-point (0-10) Numerical Rating Scale (Pain NRS)
次要结局
- Function(4 weeks, 3, 6 and 12 months after randomization)
- Disability(3, 6 and 12 months after randomization)
- Pain intensity(3, 6 and 12 months after randomization)
- Global perceived effect(4 weeks, 3, 6 and 12 months after randomization)
研究者
Shaiane da Silva Tomazoni
Postdoctoral fellow
Universidade Cidade de Sao Paulo