跳至主要内容
临床试验/NCT03750474
NCT03750474Unknown不适用

Comparison of the Stiffness of the Lumbar Back Muscles Between Low Back Pain and Healthy Controls Using Magnetic Resonance Elastography and Shear Wave Elastography

Assistance Publique - Hôpitaux de Paris2 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2018年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
52
试验地点
2
主要终点
Stiffness mapping and measurement of the shear modulus (m/s) in the multifidus and the erector spinae (1) with magnetic resonance elastography (Aera; 1,5T)

研究概览

简要总结

Chronic low back pain remains a major public health issue. Low back pain is frequently associated with stiffness changes of the lumbar back muscles. The techniques which assess the stiffness of the back muscles are poorly reliable and do not allow the quantification of stiffness changes. Elastography (magnetic resonance imaging and ultrasound) can be used to objectively and non-invasively quantify in vivo tissue elasticity. The aim of the investigator's study is to compare the stiffness in the main lumbar back muscles (i.e. the erector spinae and the multifidus) by using magnetic resonance elastography and shear wave elastography.

详细描述

"Chronic low back pain (CLBP) is commonly associated with increased trunk stiffness detected by quick release methods and motion track systems as well as increased back muscles stiffness identified by manual palpatory procedures or strain elastography. However, these techniques are qualitative and operator dependent, hence they remain poorly reliable.

Over the last decade, imaging techniques have become very helpful to characterize the biomechanical properties of tissues in vivo. Today, supersonic shear wave elastography (SWE) allows real time mapping of the elastic shear modulus. Also, magnetic resonance allows mapping and quantifying stiffness within a large volume of tissue. Elastography is efficient in the characterization of passive and active muscle forces, in highlighting the influence of muscle stiffness on joint stiffness and in showing stiffness changes related to muscle diseases Imaging plays a key role in the management of CLBP; It allows to reach specific radiological diagnosis such as tumor, inflammatory, or arthritis. However, in many cases, MRI did not find a specific cause to low back pain and the low back pain is reported as "non-specific". Myofascial disorders are also responsible for non-specific CLBP.

The main objective of this study is to compare the shear modulus of the main lumbar back muscles (erector spinae and multifidus) between patients with low back pain and healthy controls.

Second objectives are to assess: the relationship between the stiffness of the back muscles and clinical stiffness, the influence of age and sex on the elasticity of the back muscles, the relationship between the surface of the paravertebral muscles and the elasticity; the relationship between the elasticity of the hypaxial muscles (in front of the spine) and the epaxial muscles (behind the spine =back muscles), the relationship between fatty infiltration and elasticity of the back muscles, the relationship between inflammation / edema of back muscles and stiffness of the back muscles, the influence of the muscular stretching on the elasticity of the paravertebral muscles, the difference of elasticity in the direction of the muscle fibers (oblique coronal) and perpendicular (axial), the stiffness difference the between the right and left muscles, the role of different postures on muscle elasticity, the relationship between the elasticity of the back muscles and the intensity and type of pain, the relationship between the elasticity of the paravertebral muscles and disco-vertebral and / or posterior apophyseal pathology.

The inclusion of 26 patients and 26 controls will demonstrate a difference in mean elasticity modulus of 1.1 standard deviation (between patients and controls), with 90% and an alpha risk of 5%.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

patient with chronic low back pain

Experimental

magnetic resonance elastography and shear wave elastography of the back muscles

干预措施: magnetic resonance elastography and shear wave elastography (Diagnostic Test)

healthy controls

Other

magnetic resonance elastography and shear wave elastography of the back muscles

干预措施: magnetic resonance elastography and shear wave elastography (Diagnostic Test)

结局指标

主要结局

Stiffness mapping and measurement of the shear modulus (m/s) in the multifidus and the erector spinae (1) with magnetic resonance elastography (Aera; 1,5T)

时间窗: 18 months

First, the subjects undergoes a magnetic resonance elastography in decubitus in two postures: at rest and with stretching of back muscles (hip flexion). Then, stiffness will be measurement with sonography in several postures: prone position, upright, bending forward, bending backward.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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