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临床试验/NCT03600207
NCT03600207Unknown不适用

The Effect of Diaphragm Muscle Training on Chronic Low Back Pain

Szeged University2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2017年9月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
2
主要终点
Pain assessed by Visual Analogue Scale (followed by its scale information in the Description)

研究概览

简要总结

Brief Summary: Low back pain is very common problem in all the developed countries and affects children to elderly. Based on the etiology the low back pain is divided into two type: nonspecific and specific low back pain. If the pathological reason is known it is defined as specific and if the reason for the pain is unknown it is defined as nonspecific low back pain. The postulated reason for nonspecific low back pain is the segmental instability of the lumbar spine. Diaphragm muscle has a role in maintaining the segmental stability. The aim of this study to reduce the severity of the low back pain with improving the stability of the lumbar spine by using diaphragm training.

详细描述

The study is a randomized controlled trial. The participants are divided randomly into two groups. One of the groups take part in a complex training which contains stretching, strengthening, mobilizing exercises and proprioceptive training and this training is completed by diaphragm strengthening exercises. This group is defined as diaphragm training group. The members of the diaphragm training group use the POWERbreathe Medic Plus device. Opposed to the diaphragm training group the members of the control group take part only in the complex training without strengthening the diaphragm muscle. The pain intensity is assessed by Visual Analogue Scale and the diameter of the stabilizer muscles' belly is measured by B-mode ultrasound examination, using Zonare Z.One Ultrasound System (Mountain View, CA, USA). The thickness of the transversus abdominis muscle, the lumbar multifidus muscle and the diaphragm muscle is assessed in two different positions: during lying and during sitting position with weightlifting. The muscles are measured in two different states: a relaxed and a contracted state. Functional tests and a balance platform (NeuroCom) are used to measure the stability, and the function of the diaphragm is assessed by using a POWERbreathe KH2 device.

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

性别
All
接受健康志愿者

入选标准

  • Chronic low back pain
  • Do not take part in other treatment
  • Be able to learn the usage of diaphragm trainer

排除标准

  • Balance problems with neurological cause
  • Malignant tumor
  • Serious organ disease
  • Respiratory disease
  • A previous surgical intervention which affected the trunk
  • The patient is unable to cooperate

研究组 & 干预措施

Control group -complex training

Active Comparator

complex training

干预措施: Complex training (Other)

Experimental group -diaphragm training

Active Comparator

diaphragm training

干预措施: Complex training (Other)

Experimental group -diaphragm training

Active Comparator

diaphragm training

干预措施: Diaphragm training (Other)

结局指标

主要结局

Pain assessed by Visual Analogue Scale (followed by its scale information in the Description)

时间窗: 8 weeks

The severity of the pain is measured with Visual Analogue Scale (VAS) before and after the intervention. This is a semi-objective, self-report device that is used extensively to measure such complaints as pain. The sclale is a 10 cm line. The scale is anchored by 'no pain' (0 score) and 'worst imaginable pain' (score of 10). Therefore the higher values represent a worse outcome. When using the Visual Analogue Scale, the participants had to mark on a 10 cm long line the average severity of lumbar pain and we measured the distance of their mark from the zero point in cm-s.

Thickness of the stabilizer muscles' belly

时间窗: 8 weeks

The thickness of the stabilizer muscles's belly is measured with an ultrasound examination (Zonare Z.One Ultrasound System). The assessed muscles are transversus abdominis muscle, diaphragm muscle and lumbar multifidus muscle before and after the intervention.

次要结局

  • Respiratory muscles' function(8 weeks)
  • Limits of stability in sitting(8 weeks)
  • Functional skills(8 week)
  • Balance and stability(8 weeks)

研究者

发起方
Szeged University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Tamás Bender

Clinical Professor

Szeged University

研究点 (2)

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