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临床试验/NCT03507296
NCT03507296已完成不适用

Spinal Kinematics Variability in Healthy Subjects and Patients With Chronic Low Back Pain in Different Functional Activities

Haute Ecole de Santé Vaud1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2018年4月13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
40
试验地点
1
主要终点
Spinal kinematics

研究概览

简要总结

This study will test the within and between day variability of spinal kinematics and trunk muscle activity in healthy subjects and chronic low back pain patients during various daily-life activities.

详细描述

This study will test the within and between day variability of spinal kinematics and trunk muscle activity in healthy subjects and chronic low back pain patients during various daily-life activities. Participants will come twice to the motion laboratory. During the first session, participants will first perform different functional activities (V1), such as sit-to-stand, gait, lifting tasks, stepping up. Their spinal kinematics will be measured with a camera-based system (VICON) using a multi-segment spinal model and trunk muscles activity will be recorded with surface electromyography. After a break, participants will have to perform all the functional activities a second time (V2). These two measures (V1 and V2) will be used to determine the within day variability of spinal kinematics. Finally, all participants will come one week later (V3) to repeat all the measurements to determine the between day variability.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • sufficient French level to understand the instructions for the tests, the information sheet, the consent form and the questionnaires
  • All chronic low back pain patients should present with non-specific low back pain (pain from lower ribs to gluteal folds) for more than 3 months.

排除标准

  • pregnancy
  • body mass index (BMI) that is above 32
  • patients should not have any sign of specific low back pain such as the presence of infection, rheumatological or neurological diseases, spinal fractures, any known important spinal deformities, previous back surgery that limits spinal mobility, tumours
  • high level of pain at the time of experiment that prevents repeated movements (severity and irritability)
  • other concomitant pain or condition that could compromise the evaluation of spinal kinematics.

结局指标

主要结局

Spinal kinematics

时间窗: Change between measure 1 and measure 3 (day 7)

Range of movement at the lower lumbar, upper lumbar, lower thoracic and upper thoracic joints

Trunk muscle activity

时间窗: Change between measure 1 and measure 3 (day 7)

Surface electromyography of paraspinal, rectus abdominis and external obliques muscles

次要结局

  • Back Pain Attitudes Questionnaire(Measure 1 (Day 0), Measure 3 (Day 7).)
  • Pain expectation(Measure 1 (Day 0), Measure 2 (Day 0), Measure 3 (Day 7).)
  • Pain intensity(Measure 1 (Day 0), Measure 3 (Day 7))
  • Disability(Measure 1 (Day 0), Measure 3 (Day 7))
  • Fear(Measure 1 (Day 0), Measure 2 (Day 0), Measure 3 (Day 7).)
  • Disability (ODI)(Measure 1 (Day 0), Measure 3 (Day 7).)
  • Kinesiophobia(Measure 1 (Day 0), Measure 3 (Day 7).)
  • Catastrophizing(Measure 1 (Day 0), Measure 3 (Day 7).)

研究者

发起方
Haute Ecole de Santé Vaud
申办方类型
Other
责任方
Sponsor

研究点 (1)

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