Effectiveness of the Addition of the Kinesio Taping Method to Conventional Physical Therapy Treatment in Patients With Chronic Nonspecific Low Back Pain: A Randomized 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 determine the effectiveness of the addition of the use of Kinesio Taping in patients with chronic nonspecific low back pain who receive conventional physical therapy.
详细描述
One hundred and forty-eight patients will be randomized to receive either conventional physical therapy, which consist of a combination of manual therapy techniques, general exercises and specific exercises for spinal segmental stabilization (Conventional Physical Therapy Group) or to receive conventional physical therapy plus the addition of the Kinesio Taping in the lumbar spine (Conventional Physical Therapy plus Kinesio Taping), over a period of 5 weeks (10 sessions of treatment).
Clinical outcomes (pain intensity, disability and global perceived effect ) will be collected at baseline and at 5 weeks, 3 and 6 months after randomization. Data will be collected by a blinded examiner who will be unaware about the group allocation. All statistical analysis will be conducted following the principles of intention to treat analysis and the between-group differences will be performed using 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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with non-specific low back pain longer than 12 weeks
- •Seeking care for low back pain
排除标准
- •Contra indications to physical exercise
- •Serious spinal pathologies (e.g. tumors, fractures and inflammatory diseases)
- •Nerve root compromise
- •Contra indications to the Kinesio Taping (e.g. intolerance to tapes, band aids etc)
- •Pregnancy
- •Severe cardiorespiratory conditions
结局指标
主要结局
Pain Intensity
时间窗: Five 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 associated with low back pain will be measured by the 24-item Roland Morris Disability Questionnaire
次要结局
- Pain Intensity(3 and 6 months after randomization)
- Disability(3 and 6 months after randomization)
- Global impression of recovery(5 weeks, 3 and 6 months after randomization)
研究者
Luciola da Cunha Menezes Costa
Associate Professor
Universidade Cidade de Sao Paulo