Effectiveness of the Functional Exercises in Young Adults Chronic Low Back Pain: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Low back of pain intensity measured with Numeric Pain Rating Scale
研究概览
简要总结
Non-specific low back pain is a common condition. Exercise is effective treatment for chronic low back pain. We hypothesized the functional exercise group will present pain reduction and functional improvement.
The purpose of this study is investigated the effectiveness of an functional exercise program for people with nonspecific chronic low back pain. Patients will be randomly divided into 2 groups: control group (minimal intervention - mini back school and analgesic) and group will receive a functional exercise protocol associated with minimal intervention.
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 18 and 50 years
- •Low back pain for more than 3 months
- •Low back pain with numeric pain scale between 3 - 8 cm
- •Understand Portuguese well enough to be able to fill in the questionnaires
排除标准
- •Inflammatory/rheumatological diseases, tumor, infection or vertebral fracture;
- •Main pain as leg pain (eg: nerve root compression or herniated disc with radicular pain / radiculopathy, lateral and central stenosis)
- •Less than 6 months after lumbar spine, lower limb or abdomen surgery
- •Previous spinal surgery;
- •Previous spinal infiltration for pain relief in the last 3 months;
- •Several scoliosis;
- •Litigation;
- •Pregnancy;
- •Fibromyalgia;
- •People who had changed physical activity or undergone physical therapy in the previous 3 months;
- •Presence of any contraindication to exercise;
- •Planned travel in the next 12 weeks;
- •Geographic inaccessibility.
研究组 & 干预措施
Functional exercise
干预措施: Functional Exercise Protocol (Other)
Functional exercise
干预措施: Minimal (Other)
Control Group
干预措施: Minimal (Other)
结局指标
主要结局
Low back of pain intensity measured with Numeric Pain Rating Scale
时间窗: Baseline, 6, 12 and 24 weeks
It will be measured by the Brazilian version of the Numeric Pain Rating Scale (NPRS) 11 points. The NPRS goes from 0 to 10, where 0 is "no pain" and 10 is "the worst pain imaginable." Participants will be asked to answer about their pain levels based on the last seven days. Change in pain score or an improvement of 2 levels or more is accepted as clinically relevant.
次要结局
- Fear of movement measured with Fear-Avoidance Beliefs Questionnaire(Baseline, 6, 12 and 24 weeks)
- Function measured with the 6-minute walk test(Baseline, 6, 12 and 24 weeks)
- Function measured with the timed to up and go test(Baseline, 6, 12 and 24 weeks)
- Patient's global impression of recovery measured with a likert scale(6, 12 and 24 weeks after baseline)
- Analgesic consumption(6, 12 and 24 weeks after baseline)
- Disability associated to low back pain measured with Oswestry Disability Index(Baseline, 6, 12 and 24 weeks)
- Quality of life measured with Short form-36 questionnaire(Baseline, 6, 12 and 24 weeks)
- Disability associated to low back pain measured with Roland Morris Disability(Baseline, 6, 12 and 24 weeks)
研究者
Emilia Moreira, PT
Pfysiotherapist, MsC
Federal University of São Paulo