Effect of a Supervised Exercise Program on Paraspinal Muscle Morphology and Function in Patients With Chronic Low Back Pain: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change in multifidus muscle size (cross-sectional area)
研究概览
简要总结
This study evaluates the effect of a supervised exercise program on paraspinal muscle morphology and function, as well as disability/function in patients with non-specific chronic low back pain. Half of the participants will do a targeted paraspinal muscle exercise program, while the other half will do a general exercise program.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •chronic nonspecific LBP (>3 months), defined as pain in the region between the lower ribs and gluteal folds, with or without leg pain
- •currently seeking care for LBP
- •between 18 and 60 years of age
- •English or French speaker
- •score of "moderate" or "severe" disability on the ODI questionnaire
- •do not currently engage in sports or fitness training specifically for the lower back muscles (3 months prior the beginning of the study).
排除标准
- •evidence of nerve root compression or reflex motor signs deficits (e.g. weakness, reflex changes, or sensory loss with same spinal nerve)
- •previous spinal surgery or vertebral fractures
- •other major lumbar spine structural abnormalities (e.g. spondylolysis, spondylolisthesis, or lumbar scoliosis >10°)
结局指标
主要结局
Change in multifidus muscle size (cross-sectional area)
时间窗: Baseline, 6-week, 12-week
Multifidus muscle cross-sectional area measurements will be obtained from magnetic resonance imaging (MRI) from L1 to L5 spinal levels.
Change in multifidus muscle fatty infiltration
时间窗: Baseline, 6-week, 12-week
Multifidus muscle fatty infiltration (composition) measurements will be obtained from magnetic resonance imaging (MRI) from L1 to L5 spinal levels.
次要结局
- Change in Oswestry Low Back Pain Disability Index (ODI)(Baseline, 6-week, 12-week, 24-week)
- Change in Insomnia Severity Index (ISI)(Baseline, 6-week, 12-week, 24-week)
- Change in12-item Short Form Health Survey (SF-12)(Baseline, 6-week, 12-week, 24-week)
- Change in Tampa Scale of Kinesiophobia (TSK)(Baseline, 6-week, 12-week, 24-week)
- Change in The Pain Catastrophizing Scale (PCS)(Baseline, 6-week, 12-week, 24-week)
- Change in Visual Numerical pain rating scale (NPR)(Baseline, 6-week, 12-week, 24-week)
- Change in The International Physical Activity Questionnaire (IPAQ)(Baseline, 6-week, 12-week, 24-week)
- Change in paraspinal muscle size (cross-sectional area)(Baseline, 6-week, 12-week)
- Change in paraspinal muscle fatty infiltration(Baseline, 6-week, 12-week)
- Change in The Hospital Anxiety and Depression Scale (HADS)(Baseline, 6-week, 12-week, 24-week)
- Change in lumbar extensor muscle strength(Baseline, 6-week, 12-week)
- Change in multifidus muscle function (% thickness change)(Baseline, 6-week, 12-week)
研究者
Maryse Fortin
Assistant Professor
Concordia University, Montreal