Efficacy Comparison of the Exercises Based on the Lumbar Extension and Flexion in Chronic Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Average Back pain VAS score (0~10) at 12 month
研究概览
简要总结
This study is to compare the efficacy of exercises based on the lumbar extension and flexion on the pain relief and the prevention of pain recurrence in chronic low back pain patients.
详细描述
68 people that meet the inclusion criteria on screening test are assigned to one of two groups by randomization. Each of the group learns one of the exercises based on the lumbar extension or flexion for four weeks. The main outcome variables are measured and compared respectively in baseline, immediately after the education, 3, 6, 12 months after the enrollment. Finally lumbar extension exercise is verified whether it is more effective than the lumbar flexion exercise on the pain relief and the prevention of pain recurrence in chronic low back pain patients.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •chronic low back pain (>6 months, VAS score of 5 or above)
- •presence of discogenic or axial pain
- •duration of >6 months
排除标准
- •Spondylolisthesis or retrolisthesis on radiograph
- •Hx of spine surgery
- •Hx of any spine intervention within 3 months
- •other neurological, inflammatory, or poor medical conditions
- •who cannot understand or conduct the protocol of the study
结局指标
主要结局
Average Back pain VAS score (0~10) at 12 month
时间窗: Baseline, Month 1, Month 3, Month 6, Month 12
Describe the degree of pain by VAS score
次要结局
- brief pain inventory (right now pain, worst pain, least pain, pain interference)(Baseline, Month 1, Month 3, Month 6, Month 12)
- How often did the subject conduct exercise in the past a month? (5 levels)(Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 12)
- EQ-5D(Baseline, Month 1, Month 3, Month 6, Month 12)
- PASE(Baseline, Month 1, Month 3, Month 6, Month 12)
- Oswestry Disability Questionnaire(Baseline, Month 1, Month 3, Month 6, Month 12)
研究者
Sun Gun Chung
Professor
Seoul National University Hospital