Functional Correlations, Utility Model and Effectiveness of Respiratory Training in Low Back Pain: Health and Gender Education
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- Diaphragm muscle thickness
研究概览
简要总结
Objective: To determine the effectiveness of bilateral and simultaneous diaphragm visual biofeedback reeducation by ultrasonography in conjunction with high-intensity inspiratory muscle training versus isolated high-intensity inspiratory muscle training in patients with low back pain. Methods: A single blinded randomized clinical trial will be carried out. A total sample of 96 patients with low back pain will be recruited and randomized into 2 groups: one group will be treated by isolated high-intensity inspiratory muscle training during 8 weeks, and another group will be treated with bilateral and simultaneous diaphragm visual biofeedback reeducation by ultrasonography during 6 weeks in conjunction with high-intensity inspiratory muscle training during 8 weeks. Outcome measurements will be diaphragm muscle thickness evaluated by ultrasonography (main outcome measurement), pain intensity, pressure pain threshold, disability, quality of life and respiratory parameters by spirometry, which will be assessed before and after intervention.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with low back pain during 6 weeks
排除标准
- •Neural disorders
- •Systemic disorders
- •Cognitive disorders
结局指标
主要结局
Diaphragm muscle thickness
时间窗: Change from Baseline diaphragm muscle thickness at 8 weeks
Diaphragm muscle thickness in centimeters evaluated by ultrasonography
次要结局
- Pressure pain threshold(Change from Baseline pressure pain threshold at 8 weeks)
- Health-related quality of life scores(Change from Baseline health-related quality of life scores at 8 weeks)
- Pain intensity: Visual Analogue Scale(Change from Baseline pain intensity at 8 weeks)
- Disability(Change from Baseline disability at 8 weeks)
- Respiratory parameters percentage(Change from Baseline respiratory parameters percentage at 8 weeks)
研究者
César Calvo Lobo
Principal Investigator
Universidad Complutense de Madrid