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

March 8, 2021 updated by: Martin Descarreaux, Université du Québec à Trois-Rivières
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

55

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Trois-Rivières, Quebec, Canada, G8Z 4M3
        • Université du Québec à Trois-Rivières

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with neurogenic or vascular claudication

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
LSS group
Participants with a diagnosis of lumbar spinal stenosis
Diagnostic test: Treadmill walking test
Participants will be invited to walk on a treadmill at a speed of 1,2 mph for at most five minutes for both conditions (straight walking posture and inclined walking posture). Each walking posture condition will be followed by a rest time of five minutes in sitting position. Conditions were randomized in each group using a computer-generated sequence.
PAD group
Participants with a diagnosis of peripheral artery disease
Diagnostic test: Treadmill walking test
Participants will be invited to walk on a treadmill at a speed of 1,2 mph for at most five minutes for both conditions (straight walking posture and inclined walking posture). Each walking posture condition will be followed by a rest time of five minutes in sitting position. Conditions were randomized in each group using a computer-generated sequence.
LBP group
Participants with a diagnosis of non specific low back pain
Diagnostic test: Treadmill walking test
Participants will be invited to walk on a treadmill at a speed of 1,2 mph for at most five minutes for both conditions (straight walking posture and inclined walking posture). Each walking posture condition will be followed by a rest time of five minutes in sitting position. Conditions were randomized in each group using a computer-generated sequence.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Leg and back Pain (Visual analog scale)
Time Frame: Before the walking test, through the walking test completion, at 2:30 minutes of rest, at 5 minutes of rest
leg and back pain using a 0-10 points 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)
Time Frame: day 1, before the walking test (this is a transversal study)
WIQdistance subscale score range from 0 to 100%, WIQspeed subscale score range from 0 to 100%, WIQstairs subscale score range from 0 to 100%, WIQ total score combining distance,speed and stairs subscale range from 0 to 100% Higher values indicate better outcome
day 1, before the walking test (this is a transversal study)
Tampa Scale of kinesiophobia
Time Frame: day 1, before the walking test (this is a transversal study)
Questionnaire, Total score range from 17 to 68, Higher score indicate a worst outcome
day 1, before the walking test (this is a transversal study)
Quality of life of participants
Time Frame: day 1, before the walking test (this is a transversal study)
EuroQol 5 dimension (EQ-5D), each section (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) has a score ranging from 1 to 3 and higher values indicate a worst outcome
day 1, before the walking test (this is a transversal study)
Impact of pain, function and surgery satisfaction
Time Frame: day 1, before the walking test (this is a transversal study)
French-Canadian adaptation of the Swiss Spinal Stenosis Questionnaire Pain subscale score range from 7 to 35 with higher values indicate a worst outcome, Function subscale score range from 5 to 20 with higher values indicate a worst outcome, Satisfaction subscale score range from 6 to 24 with higher values indicate a worst outcome. The total score is composed of the three subscales and range from 18 to 79.
day 1, before the walking test (this is a transversal study)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Université du Québec à Trois-Rivières

Investigators

  • Study Director: Martin Descarreaux, DC, PhD, Université du Québec à Trois-Rivières

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2018

Primary Completion (Actual)

March 30, 2020

Study Completion (Actual)

March 30, 2020

Study Registration Dates

First Submitted

August 9, 2019

First Submitted That Met QC Criteria

August 13, 2019

First Posted (Actual)

August 15, 2019

Study Record Updates

Last Update Posted (Actual)

March 9, 2021

Last Update Submitted That Met QC Criteria

March 8, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UQTR-2017-claudication

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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