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临床试验/NCT04097873
NCT04097873已完成不适用

Effectiveness of Ultrasonography Visual Biofeedback for Diaphragm Training in Athletes With Non-specific Lumbo-pelvic Pain

Universidad Complutense de Madrid1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2020年7月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
1
主要终点
Diaphragm muscle thickness

研究概览

简要总结

Objective: To determine the effectiveness of diaphragm visual biofeedback reeducation by ultrasonography in conjunction with high-intensity inspiratory muscle training versus isolated high-intensity inspiratory muscle training in athletes with lumbo-pelvic pain. Methods: A single blinded randomized clinical trial will be carried out. A total sample of 80 athletes with lumbo-pelvic 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 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

  • •Athletes with non-specific lumbopelvic pain during 6 weeks

排除标准

  • •Neural disorders
  • •Systemic disorders
  • •Cognitive disorders

研究组 & 干预措施

Diaphragm biofeedback reeducation plus inspiratory training

Experimental

干预措施: Diaphragm ultrasonography reeducation plus inspiratory training (Other)

Isolated high-intensity inspiratory muscle training

Active Comparator

干预措施: Isolated inspiratory training (Other)

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

  • Pain intensity(Change from Baseline pain intensity at 8 weeks)
  • Pressure pain threshold(Change from Baseline pressure pain threshold at 8 weeks)
  • Disability(Change from Baseline disability at 8 weeks)
  • Health-related quality of life scores(Change from Baseline health-related quality of life scores at 8 weeks)
  • Respiratory parameters percentage(Change from Baseline respiratory parameters percentage at 8 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

César Calvo Lobo

Principal Investigator

Universidad Complutense de Madrid

研究点 (1)

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