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临床试验/NCT02374970
NCT02374970Unknown不适用

Effectiveness of Transversus Abdominis Muscular Training in Patients With Chronic Low Back Pain

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2015年2月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
50
试验地点
2
主要终点
Change in transversus abdominis muscle thickness (Ultrasonography)

研究概览

简要总结

Low back pain is not a diagnosis; it is a symptom describing the presence of pain in the lumbar vertebral or paravertebral region without any reference to the structure or cause of the process. It is one of the most widespread diseases and one of the most common reasons for visits in primary care setting.

Exercises to improve lumbar stability involving co-contraction of the transversus abdominis have proved to be effective in reducing pain and improving function. It has been stated by ultrasound images that specific stabilization exercises cause contraction of the deep abdominal muscles, but it remains unclear whether training produce thickness muscle improvement and if this improvement is related to clinical findings.

To try to resolve this issue a project of an experimental trial, double-blind (patient and evaluator) with two groups randomly assigned is presented. All participants will be recruited in an primary care center of the Catalan Health Institut and will sign informed consent. All will receive a protocolized treatment with therapeutic exercises and thermotherapy and, additionally, those assigned to the intervention group were instructed in performing lumbar stability exercises.

Pain (VAS), function (Roland-Morris Questionnaire) and the thickness of the transversus abdominis, internal and external oblique muscles (measured by ultrasound) at baseline, end of treatment protocol (12 sessions) and three months after the end of treatment will be assessed.

Results in pain, function, and its correlation with the mean changes in the thickness of transversus abdominis will be analyzed.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18 years old and over
  • Diagnosis of chronic low back pain (over 3 months)
  • Sign the informed consent form.

排除标准

  • Non-stand supine position
  • Neural Irradiation pain
  • Previous surgical intervention in low back region
  • Heart pathology
  • Pregnancy
  • Pending litigation or legal claim
  • Poor language and communication skills making difficult to understand the informed consent

结局指标

主要结局

Change in transversus abdominis muscle thickness (Ultrasonography)

时间窗: Baseline, 15 days after, and three months after

次要结局

  • Change in pain intensity (Visual analogue scale)(Baseline, 15 days after, and three months after)
  • Disability (Roland-Morris questionnaire)(Baseline, 15 days after, and three months after)
  • Change in internal oblique muscle thickness (Ultrasonography)(Baseline, 15 days after, and three months after)
  • Change in external oblique muscle thickness (Ultrasonography)(Baseline, 15 days after, and three months after)
  • Patient perception of change (Global Rating of Change scale)(15 days after recruitment, and three months after)

研究者

发起方
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
申办方类型
Other
责任方
Sponsor

研究点 (2)

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