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临床试验/NCT03633578
NCT03633578已完成不适用

Relationship Between Complexity and Pain in a Walking Task With Distraction in the Chronic Low Back Pain Patient by Fractal Analysis: Pilot Study

Centre Hospitalier Universitaire de Nīmes2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2018年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
16
试验地点
2
主要终点
Estimation of the fractal exponent when walking without distraction at the speed of 130% of the preferential speed

研究概览

简要总结

Motor control, notably expressed through the complexity of the variability of the locomotor pattern, is disturbed at the central level by an apprehension of pain and movement, more than pain itself (or by biomechanical / structural damage of the spine) in chronic low back pain (cLBP) patients.

The aim of this study is to control that variability is reduced during gait at comfortable level and to test that distraction can reduce pain avoidance and therefore increase variability in cLBP patients.

研究设计

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

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •The patient must have his informed consent and signed the consent form.
  • •The patient must be affiliated or beneficiary of a health insurance plan
  • •The patient is at least 18 years old and under 75 years old
  • •Patients with common chronic low back pain for more than 6 months

排除标准

  • •The subject participates in another interventional study
  • •The subject is in an exclusion period determined by a previous study
  • •The subject is under the protection of justice, guardianship or curatorship
  • •The subject refuses to sign the consent
  • •It is impossible to inform the subject
  • •Chronic symptomatic low back pain (tumoral pathology, infectious, or progressive inflammatory)
  • •Unable to walk for more than 10 minutes (during interrogation)
  • •Lower limb pain (EVA lower limb (s) ≥ Lumbar EVA)

研究组 & 干预措施

Interventional group

Experimental

Patients are asked to walk ont a treadmill in four conditions: with and without distraction (virtual environment) and at different speed (comfortable vs high).

干预措施: walk test (Behavioral)

结局指标

主要结局

Estimation of the fractal exponent when walking without distraction at the speed of 130% of the preferential speed

时间窗: Day 0

\[0,5; 1,5\]

Estimation of the fractal exponent when walking with distraction at the speed of 130% of the preferential speed

时间窗: Day 0

\[0,5; 1,5\]

Estimation of the fractal exponent when walking without distraction at preferential speed

时间窗: Day 0

\[0,5; 1,5\]

Estimation of the fractal exponent when walking with distraction at preferential speed

时间窗: Day 0

\[0,5; 1,5\]

次要结局

  • Reaction time to auditory stimuli without distraction at the speed of 130% of the preferential speed(Day 0)
  • Dallas Pain Questionnaire for Back Pain(Day 0)
  • Quebec Back Pain Disability Index(Day 0)
  • Hospital and Anxiety Depression Scale(Day 0)
  • Reaction time to auditory stimuli with distraction at the speed of 130% of the preferential speed(Day 0)
  • Fear Avoidance Belief Questionnaire (FABQ)(Day 0)
  • Tampa Scale for kinesophobia(Day 0)
  • EVA after walking without distraction at preferential speed(Day 0)
  • EVA after walking with distraction at preferential speed(Day 0)
  • EVA after walking without distraction at the speed of 130% of the preferential speed(Day 0)
  • EVA after walking with distraction at the speed of 130% of the preferential speed(Day 0)
  • Reaction time to auditory stimuli without distraction at preferential speed(Day 0)
  • Reaction time to auditory stimuli with distraction at preferential speed(Day 0)

研究者

发起方
Centre Hospitalier Universitaire de Nīmes
申办方类型
Other
责任方
Sponsor

研究点 (2)

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