Efficacy of the Mckenzie Method 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
- Pain Intensity
研究概览
简要总结
The purpose of this study is to assess the efficacy of the McKenzie method in patients with chronic non-specific low back.
详细描述
One hundred and forty-eight patients will be randomly allocated to two treatment groups: McKenzie method or Placebo (detuned ultrasound and short wave therapy) for 5 weeks (total of 10 sessions of 30 minutes each).
The clinical outcomes will be obtained at the completion of treatment (5 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 constructing mixed linear models.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 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 months), with a pain intensity of at least 3 points measured by a 0-10 points pain numerical rating scale, aged between 18 and 80 years and able to read in Portuguese.
排除标准
- •patients will be excluded if they have any contraindication to physical exercise or ultrasound or short wave therapy, 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 and pregnancy.
结局指标
主要结局
Pain Intensity
时间窗: 5 weeks after randomization
Pain Intensity will be measured by an 11-point (0-10) Numerical Rating Scale (Pain NRS)
Disability
时间窗: Five weeks after randomization
Disability will be measured by the 24-item Roland Morris Disability Questionnaire
次要结局
- Kinesiophobia(Five weeks, 3, 6 and 12 months after randomization)
- Pain Intensity(3, 6 and 12 months after randomization)
- Disability(3, 6 and 12 months after randomization)
- Function(Five weeks, 3, 6 and 12 months after randomization)
- Global perceived effect(Five weeks, 3, 6 and 12 months after randomization)
研究者
Luciola da Cunha Menezes Costa
Associate Professor
Universidade Cidade de Sao Paulo