Effect of Aquatic Exercise on Paraspinal and Gluteal Morphology and Function in Patients With Chronic Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Change in multifidus muscle size (cross-sectional area) in cm^2
研究概览
简要总结
The goal of this pilot randomized controlled trial is to compare the effects of aquatic therapy versus standard care on paraspinal and gluteal morphology and function in individuals with chronic low back pain.The main questions it aims to answer are:
- What are the effects of aquatic therapy versus standard care on a) paraspinal and gluteal muscle size, composition (e.g., fatty infiltration) and b) lumbar and gluteal muscle strength in individuals with chronic LBP?
- Is aquatic therapy more effective than standard care to improve pain, function and psychological factors (e.g., kinesiophobia, catastrophizing, anxiety, and depression)?
- Is using a digital application "play the pain" feasible to monitor pain levels and the activities that participants used to cope with pain?
Participants will be assigned to either the aquatic therapy group or standard care group where they will undergo a 10-week intervention including two 60-minute session per week.
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
- None
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
- •aged between 18 and 65 years old
- •English or French speakers
- •have a score of "moderate" or "severe" disability on the modified Oswestry Low Back Questionnaire
- •do not currently engaged in sports or fitness training specifically for the lower back muscles (3 months prior the beginning of the trial).
排除标准
- •evidence of nerve root compression or reflex motor signs deficits
- •previous spinal surgery or vertebral fractures
- •other major lumbar spine structural abnormalities
- •comorbid health conditions that would prevent active participation in exercise programs
结局指标
主要结局
Change in multifidus muscle size (cross-sectional area) in cm^2
时间窗: Baseline, 10-week
Multifidus muscle cross-sectional area measurements will be obtained from magnetic resonance imaging (MRI).
Change in gluteal muscle size (cross-sectional area) in cm^2
时间窗: Baseline, 10-week
Gluteal muscle cross-sectional area measurements will be obtained from magnetic resonance imaging (MRI).
Percent change in multifidus muscle fatty infiltration in
时间窗: Baseline, 10-week
Multifidus muscle fatty infiltration (composition) measurements will be obtained from magnetic resonance imaging (MRI).
Percent change in gluteal muscle fatty infiltration
时间窗: Baseline, 10-week
Gluteal muscle fatty infiltration (composition) measurements will be obtained from magnetic resonance imaging (MRI).
次要结局
- Point score change in12-item Short Form Health Survey (SF-12)(Baseline, 10-week)
- Point score change in The International Physical Activity Questionnaire (IPAQ)(Baseline, 10-week)
- Point score change in Oswestry Low Back Pain Disability Index (ODI) score(Baseline, 10-week)
- Point score change in Insomnia Severity Index (ISI)(Baseline, 10-week)
- Point score change in The Hospital Anxiety and Depression Scale (HADS)(Baseline, 10-week)
- Point score change in Visual Numerical pain rating scale (NPR)(Baseline, 10-week)
- Point score change in Tampa Scale of Kinesiophobia (TSK)(Baseline, 10-week)
- Point score change in The Pain Catastrophizing Scale (PCS)(Baseline, 10-week)
研究者
Maryse Fortin
PhD, CAT(C)
Concordia University, Montreal