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临床试验/NCT04058171
NCT04058171已完成不适用

Validation of a Treadmill Walking Test to Discriminate Neurogenic Claudication From Vascular Claudication

Université du Québec à Trois-Rivières1 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2018年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
55
试验地点
1
主要终点
Walking time

研究概览

简要总结

The first aim of this study was to elaborate and validate a treadmill walking test that would help discriminate between neurogenic claudication from vascular claudication. The second objective of this study is to determine if the treadmill walking test can discriminate spinal stenosis from low back pain with radiating pain in lower limb.

详细描述

To date, an important challenge that clinicians hare facing in the assessment and diagnosis of intermittent claudication is that pathologies associated with vascular or neurogenic claudication can coexist in the same patient. Differentiation between both origins can be difficult due to variable signs and symptoms which can be atypical.

The first aim of this study was to elaborate and validate a treadmill walking test that would help discriminate between neurogenic claudication from vascular claudication. The second objective of this study is to determine if the treadmill walking test can discriminate spinal stenosis from low back pain with radiating pain in lower limb. 60 participants (20 with spinal stenosis, 20 with peripheral artery disease and 20 with non-specific low back pain) will be recruited. Participants will be invited to walk on a treadmill at a speed of 1,2 mph for a maximum of five minutes for both tasks (straight walking posture and inclined walking posture). Each walking task will be followed by a rest time of five minutes in sitting position. It is hypothesized that walking time difference for the occurrence of pain and for pain relief will be sensitive and specific to pathologies and help to discriminate lumbar spinal stenosis.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

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

入选标准

  • Lumbar spinal stenosis (LSS) group :
  • Central stenosis
  • Pain in at least one leg
  • Neurological signs in the lower limbs (numbness or tingling)
  • Weaknesses in the lower limb
  • Pain relieved by sitting or bending the trunk
  • Peripheral artery disease (PAD) group :
  • Claudication while walking
  • Ankle-brachial index < 0.9
  • Pain relieved by rest
  • Low back pain (LBP) :
  • Pain radiating in the lower limb
  • Weaknesses
  • Pain relieved by sitting

排除标准

  • Foraminal stenosis
  • Spinal stenosis with predominant back pain
  • Symptomatic disc herniation
  • Previous lumbar surgery
  • Previous vascular surgery
  • Type 1 diabetes
  • Knee or hip osteoarthritis
  • Hip or knee arthroplasty
  • Inability to provide free and informed consent

结局指标

主要结局

Walking time

时间窗: Time first back or leg pain (vary between participants from 0 secondes to 300 secondes and is determine by the occurence of leg or back pain), Through the walking test completion

次要结局

  • Leg and back Pain (Visual analog scale)(Before the walking test, through the walking test completion, at 2:30 minutes of rest, at 5 minutes of rest)
  • Walking impairment Questionnaire (WIQ)(day 1, before the walking test (this is a transversal study))
  • Tampa Scale of kinesiophobia(day 1, before the walking test (this is a transversal study))
  • Quality of life of participants(day 1, before the walking test (this is a transversal study))
  • Impact of pain, function and surgery satisfaction(day 1, before the walking test (this is a transversal study))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Martin Descarreaux

Principal investigator

Université du Québec à Trois-Rivières

研究点 (1)

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