Bel Ağrılı Bireylerde Egzersizlerin Uzun Dönem Devamlılığının Değerlendirilmesi
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Changes in pain severity
研究概览
简要总结
Identification of the long term effects of exercises in individuals with low back pain.
详细描述
Individuals with low back pain who will participate in the study will be divided into two groups. In the stabilization exercise group will be instructed to perform spinal stabilization exercises and in the yoga group will be instructed to perform yoga program consisting of breathing, relaxation and flexibility exercises. The intensity of the pain will be evaluated through visual analog scale, functional status and quality of life will be evaluated through Oswestry Disability Index(ODI), Nottingham Health Profile (NHP), respectively. The exercise adherence will evaluated Exercise Adherence Rating Scale (EARS). The time-distance characteristics of the gait will be evaluated by the OPTOGAIT photoelectric cell (OPTOGait, Microgate, Italy, 2010) and the treadmill system. Assessments will be repeated before, after the treatment, 6 and 12 month follow-up. Also,the number of back pain attacks of the individuals will be questioned and recorded.
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
- •Must be low back pain at least 3 months
- •Must be visual analog scale rating 3 or more
排除标准
- •History of any lumbar spine surgery
- •Severe/progressive scoliosis
- •Spinal stenosis
- •Spondylolisthesis
- •Metabolic syndrome
- •History of exercise programs or yoga at least 12 weeks before the onset of study
研究组 & 干预措施
Stabilization exercise group
Spinal stabilization exercise will be applied all patients accompanied by physiotherapist.
Sessions will be included selected exercises according to motor learning phases.
干预措施: exercise (Other)
yoga group
Yoga program will be applied all patients in this group accompanied by physiotherapist. Sessions will be included selected breathing exercises, warm up, asana and relaxation.
干预措施: exercise (Other)
结局指标
主要结局
Changes in pain severity
时间窗: change from baseline in pain intensity at 8 weeks, 6 and 12 month follow-up.
Patients' average pain intensities will be assessed by Visual Analog Scale (VAS). Participants asked to mark the intensity of pain on a 10 cm long line, explaining that the leftmost of the line does not have pain, that the pain increases while moving to the right, and that the pain is unbearable on the far right.
Changes of functional status
时间窗: change from baseline in functional status at 8 weeks, 6 and 12 month follow-up.
Patient's pain related functional status will be measured by Oswestry Disability Index. The scale is considered the 'gold standard' of low back functional outcome tools. This scale contain questions related to functional activities of pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life and traveling. The total score is between 0 and 100. The higher the score, the higher the level of disability.
次要结局
- Changes in the gait(Change from baseline in gait at 8 weeks, 6 and 12 month follow-up.)
- Changes in quality of life(Change from baseline in life quality levels at 8 weeks, 6 and 12 month follow-up.)
- Changes in Exercise Compliance(Change from baseline in exercise compliance at 8 weeks, 6 and 12 month follow-up.)
研究者
Muzeyyen Oz
Research Assistant
Hacettepe University