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临床试验/NCT02398760
NCT02398760已完成不适用

Relationship Between Clinical Tests and Clinical Outcomes After Motor Control Exercises Intervention for Non-specific Chronic Low Back Patients

Universidade Estadual Paulista Júlio de Mesquita Filho2 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2014年7月1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
68
试验地点
2
主要终点
Pain (Numerical Rating Scale (0-10)

研究概览

简要总结

Nowadays, the research priority in low back pain area have been find subgroup of patients with the same characteristics that might achieve better outcomes in a specific intervention. However, even though the studies in this area have increased, questions of this nature remaining without an adequate answer, or with limited evidence. Therefore, the investigators propose to examine the ability of clinical tests, developed to assess alterations related to clinical lumbar instability, to identify subgroups of patients with non specific chronic low back pain that may have better outcomes after a motor control exercises intervention.

详细描述

Changes relative to clinical instability are well established in individuals with non specific chronic low back pain. However, in this population, these changes vary widely, characterizing them as an heterogenous group. Motor Control Exercises (MCE) aims to improve the impaired coordination of deep and superficial muscles of the trunk, to reestablish the stability of the lumbar spine reducing the common alterations in this population, and are associated with reduction of pain and disability of patients with non specific chronic low back pain. To specific assessment of the changes found in this population, clinical tests are often used: in the assessment to identify motor control alterations; during intervention as parameter for treatment progress (e.g. to increase exercises difficulty); and after intervention, to ensure that there was normalization of the motor control. There are several clinical tests to assess changes relative to clinical instability, such as: Clinical Classification Scale (CCS) to assess abdominal muscles and the coordination between superficial and deep trunk muscles; Clinical Test of Thoracolumbar Dissociation (CTTD) to assess anterior/posterior tilt while maintain a constant position of thoracolumbar junction; and the Prone Instability Test (PIT) and Passive Lumbar Extension Test (PLET) used to detect structural lumbar instability.

Therefore, primary objectives of this study are: to investigate the ability of clinical tests in predict clinical outcomes, pain and disability, in motor control exercises program, and to investigate the association of two or more tests to predict clinical outcomes.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • between 18 and 60 years.
  • non specific chronic low back (pain for more than 3 months) with pain intensity of at least 3 points measured by pain numerical rating scale (0-10) and disability of at least 6 points in the 24-item Roland Morris Disability Questionnaire (0-24).
  • classified as low or medium risk though StarT Back Screening Tool

排除标准

  • cardiovascular and neurological pathologies
  • serious pathology in the spine and pelvic.
  • previous spinal surgery of at least 1 year before the trial period.
  • check-list with the red flags was performed to exclusion
  • classified as high risk through StarT Back Screening Tool, due these patients have high psychological components and needed of specialized psychological attendance

结局指标

主要结局

Pain (Numerical Rating Scale (0-10)

时间窗: After Intervention (2 months), 6 months

Disability (measured by 24-item Roland Morris Disability Questionnaire)

时间窗: After Intervention (2 months), 6 months

Disability will be measured by 24-item Roland Morris Disability Questionnaire

次要结局

  • Global Perceived Effect (11-point Global Perceived Effect Scale (-5-+5)(After Intervention (2 months))
  • Depression (Beck Inventory (0-63)(After Intervention (2 months))
  • Function (Patient Specific Functional Scale (0-10)(After Intervention (2 months))
  • Kinesiophobia (Tampa Scale for Kinesiophobia (17-68)(After Intervention (2 months))
  • Kinesiophobia (Fear Avoidance Beliefs Questionnaire (0-66)(After Intervention (2 months))
  • Kinesiophobia (Photograph Series of Daily Activities - Short Electronic Version (PHODA-SEV) (0-100)(After Intervention (2 months))

研究者

发起方
Universidade Estadual Paulista Júlio de Mesquita Filho
申办方类型
Other
责任方
Principal Investigator
主要研究者

Crystian Bitencourt Soares de Oliveira

Msc Student

Universidade Estadual Paulista Júlio de Mesquita Filho

研究点 (2)

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