Effects of an Exercise Program Under Supervision and Unsupervised in the Treatment of Low Back Pain: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 122
- 主要终点
- Visual Analogue Pain Scale to asses Low Back Pain
研究概览
简要总结
ABSTRACT: Low back pain is one of the most frequent causes of incapacity. The prevalence of this syndrome is 60-85% for the survival of the individuals. Among the most promising strategies of low back pain intervention, is the physical activity that is usually associated with a long list of health benefits.
详细描述
Purpose: evaluate the efficacy of a protocol of exercises to low back pain rehabilitation under supervision of physiatry service and rehabilitation in the Hospital de Clínicas de Porto Alegre compared with same protocol performed at home in regards to pain.
Methods: Randomized clinical trial with a sample of 122 subjects of the community of both sex, with ages between 30 to 55, with low back pain complain. These subjects will accomplish during 12 weeks protocol of exercises from "Exercises to low back pain" Physiatry and Rehabilitation service from HCPA, randomized in two groups: group 1 will complete all the protocol of exercises with orientation and attendance directly from a professional of physical education, in the Service of Physiatry and Rehabilitation in HCPA. Group 2 will complete one session of the protocol of exercises with orientation and attendance directly from a professional of Physical Education, in the service of Physiatry and Rehabilitation of HCPA, to clarify any doubts about the protocol. The further sessions will be completed at home, along weekly monitoring of the researchers through phone calls, the patients of this group will receive a manual with the sequence of the exercises.
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 (Investigator)
入排标准
- 年龄范围
- 30 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •ages between 30 and 55
- •Pain should be without radiation to lower body
- •Pain with more than 12 weeks of evolution.
- •Visual Analog Scale of Pain (VAS) should present a pattern above 3 (moderate).
排除标准
- •Patients with Exclusion Criteria: will be excluded those patients that present musculoskeletal impairment in lower body,
- •After surgery and anesthetic block.
- •individuals affected with comorbidities
- •Patients with rheumatic diseases, recent fractures, tumors, pregnant women, smokers and general practitioners of physical activity.
- •Subjects who are unable to attend the hospital twice a week.
结局指标
主要结局
Visual Analogue Pain Scale to asses Low Back Pain
时间窗: 24 months
Visual Analogue Pain Scale (EVA) - change from baseline pain after the intervention - evaluates the intensity of pain using a ruler divided into eleven equal parts, with a classification from 0 (painless) and 10 (maximum pain).
次要结局
- Short-Form Survey (SF-36) to evaluate life quality(24 months)
- Six minutes walk-test - Functional capacity(24 months)
- sit and reach test - flexibility(24 months)