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Clinical Trials/NCT04058171
NCT04058171CompletedNot Applicable

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

Université du Québec à Trois-Rivières1 site in 1 country55 target enrollmentStarted: May 1, 2018Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
55
Locations
1
Primary Endpoint
Walking time

Study Overview

Brief Summary

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.

Detailed Description

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
40 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Walking time

Time Frame: 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

Secondary Outcomes

  • 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))

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Martin Descarreaux

Principal investigator

Université du Québec à Trois-Rivières

Study Sites (1)

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