Effects of Core Stability Exercises and Cognitive Tasks Compared to General Exercises and Cognitive Tasks on Chronic Non-specific Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Oswestry Disability Index
研究概览
简要总结
This randomized control trial study aims to compare the effect of core stability exercises and cognitive tasks with general exercises and cognitive tasks on pain, disability, and postural control strategies of chronic non-specific low back pain patients. The main questions are:
- Are core stability exercises and cognitive tasks more effective than general exercises and cognitive tasks in reducing the pain of chronic non-specific low back pain patients?
- Are core stability exercises and cognitive tasks more effective than general exercises and cognitive tasks in reducing the disability of chronic non-specific low back pain patients?
- Are core stability exercises and cognitive tasks more effective than general exercises and cognitive tasks in improving postural stability parameters of chronic non-specific low back pain patients?
- Are core stability exercises and cognitive tasks more effective than general exercises and cognitive tasks in improving stabilogram diffusion analysis parameters of chronic non-specific low back pain patients? This study is designed to apply two exercise protocols on two groups of 17 people with non-specific back pain. Group A will receive core stability exercises along with cognitive tasks, and group B will receive general exercises along with cognitive tasks.
详细描述
Patients will be aged between 18-50 years. All patients meeting the inclusion criteria will receive 16 training sessions (thrice a week). The primary outcome measure will be pain and disability. Secondary outcome measures will be postural control strategies (including postural control stability and stabilogram diffusion analysis), quality of life, fear of movement, and fear-avoidance beliefs that will be assessed before and after training sessions and at 3-month follow-up; only primary outcomes will be evaluated in each group.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Orthopedist-confirmed diagnosis of chronic nonspecific low back pain that has lasted at least three months since its onset.
- •Pain score of 3 or more on a visual analog scale.
- •Pain during quiet standing.
- •Cognitive level above 24 based on mini-mental state examination (MMSE).
排除标准
- •Radicular pain and any neurological signs.
- •Uncorrected vision impairment.
- •Hearing problems.
- •Vestibular dysfunctions.
- •Cognitive deficit.
- •Previous spinal surgery.
- •Severe deformity or injury to the lower extremities.
结局指标
主要结局
Oswestry Disability Index
时间窗: "Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks ", "change from baseline at three months "
Questionnaire evaluating the level of disability. Total score range from 0-100 (higher scores mean more disability)
次要结局
- Center of pressure (COP) sway range for anteroposterior (AP range)("Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks ")
- COP sway range for mediolateral (MA range)("Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks ")
- COP sway velocity("Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks ")
- Sway area("Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks ")
- Short-term diffusion coefficient of stabilogram diffusion plot("Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks ")
- Long-term diffusion coefficient of stabilogram diffusion plot("Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks ")
- Critical point coordinates.("Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks ")
- 12-item short form health survey("Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks ")
- Tampa scale for kinesiophobia("Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks ")
- Fear-avoidance beliefs questionnaire("Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks ")
- Visual analog scale("Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks ", "change from baseline at three months ")
研究者
Reza Salehi
Iran University of Medical Sciences
Iran University of Medical Sciences