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临床试验/NCT04119895
NCT04119895已完成不适用

Does Neuromuscular Electrical Stimulation Have an Additive Effect to Core Stabilization Exercises on Pain, Disability and Ultrasonographic Thickness of Abdominal and Lumbar Muscles in Chronic Low Back Pain?

Koç University2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年10月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
2
主要终点
Change in Oswestry Disability Index

研究概览

简要总结

This study evaluates whether there is additive effect of neuromuscular electrical stimulation applied to lower lumbar region to core stabilization exercises in the management of chronic low back pain. Participants will randomly divide into two groups; half will receive core stabilization exercises and neuromuscular electrical stimulation (NMES) in combination, while the other half will receive core stabilization exercises and sham NMES.

详细描述

Patients with low back pain cannot activate enough the deep lumbar stabilization muscles necessary for spinal stability, such as transversus abdominis, lumbar multifidus.

Core stabilization exercises are valuable in motor relearning of coactivation of deep lumbar and abdominal muscles and in stabilization of the spine. Hence, they are important in the management of chronic low back pain.

Neuromuscular electrical stimulation (NMES) has been used in the training and strengthening of skeletal muscles for many years. It is shown that NMES can contract deep lumbar stabilization muscles and changes in muscle activation are significantly associated with pain reduction in patients with low back pain.

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 or older,
  • Pain intensity greater than 3 over 10,
  • Pain duration more than 3 months,
  • Consent to participate in the study

排除标准

  • Previous lumbar surgery,
  • Radiculopathy,
  • Non-mechanical back pain,
  • Acute low back pain

结局指标

主要结局

Change in Oswestry Disability Index

时间窗: 4 weeks (change from baseline to 4 weeks after)

Oswestry Disability Index (ODI), measures the level of disability. It consists of 10 items questioning the severity of pain, self-care, lifting and carrying, walking, sitting, standing, sleep, the degree of pain change, travel and social life. Its Turkish version is validated in 2004. Items are scored between 0 and 5, and the total score is multiplied by two. The maximum score is "100". As the total score increases, the level of disability increases.

次要结局

  • Change in Nottingham Health Profile(4 weeks (change from baseline to 4 weeks after))
  • Change in Visual Analog Scale(4 weeks (change from baseline to 4 weeks after))
  • Change in Ultrasonographic thickness of multifidus and abdominal muscles(4 weeks (change from baseline to 4 weeks after))

研究者

发起方
Koç University
申办方类型
Other
责任方
Sponsor

研究点 (2)

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