EFFECT OF COGNITIVE-BEHAVIORAL THERAPY AND EXERCISE VERSUS SUPERVISED EXERCISE PROGRAM IN PATIENTS WITH CHRONIC PAIN LUMBAR NO SPECIFIC: RANDOMIZED CONTROLLED TRIAL
试验速览
- 阶段
- 不适用
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Functional Disability
研究概览
简要总结
The purpose of this study is to compare the efficacy of graded activity program and supervised exercise on pain, functional disability, quality of life, global perceived effect, return to work, physical activity, physical capacity and strength of the lower limbs in patients with chronic non-specific low back pain
详细描述
Objective
To contrast the efficacy of of graded activity program and supervised exercise on pain, functional disability, quality of life, global perceived effect, return to work, physical activity, physical capacity and strength of the lower limbs in patients with chronic non-specific low back pain
Design: Sixty-six will be randomized into two groups namely: Graded Activity program (GA)(n = 33) and supervised exercise (SE) (n = 33). The primary clinical outcomes will be pain, assessed with the numerical pain scale and McGill Pain Questionnaire, and disability assessed with Roland Morris Disability Questionnaire. Secondary outcomes will be measured with Global Perceived Effect, quality of life, return to work, physical activity, functional capacity and strength of the lower limbs. The program lasts for 6 weeks, and sessions happen twice a week, with duration of one hour each. Evaluations will be performed before(baseline), after (6weeks) and with a follow-up 3 and 6 months after treatment. Data will be collected by a blinded examiner who also had made the allocation of patients to groups. Significance level is established at 5%.
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 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 low back pain for at least three months, age between 18 and 65 year of both genders and with a minimum pain intensity score of three in the 11-point Pain Numerical Rating Scale (ranging from 0 to 10 points).
排除标准
- •Known or suspected serious spinal pathology (fractures, tumors, inflammatory or infective diseases of the spine);
- •Nerve root compromise;
- •Comorbid health conditions that would prevent active participation in the exercise programs;
- •Pregnancy;
- •Cardio Respiratory illnesses;
研究组 & 干预措施
Graded Activity
Exercise treadmill, Strengthening of the lower limbs and trunk
干预措施: Graded Activity (Other)
Supervised exercises
Stretching, Strengthening, Motor Control
干预措施: Graded Activity (Other)
Graded Activity
Exercise treadmill, Strengthening of the lower limbs and trunk
干预措施: Supervised Exercises (Other)
Supervised exercises
Stretching, Strengthening, Motor Control
干预措施: Supervised Exercises (Other)
结局指标
主要结局
Functional Disability
时间窗: 6 weeks
Roland Morris Disability Questionnaire
Pain
时间窗: 6 weeks
Pain Numerical Rating Scale (NRS) and McGill Pain Questionnaire
次要结局
- Return to work(6 weeks)
- Quality of life(6 weeks)
- Habitual physical activity(6 weeks)
- Physical Capacity(6 weeks)
- Global Perceived Effect(6 weeks)
- Kinesiophobia(Tampa Scale of Kinesophobia (TSK))
研究者
Mauricio Oliveira Magalhães
Mauricio Oliveira Magalhães
University of Sao Paulo