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

Sponsor
Université du Québec à Trois-Rivières (Other)
Overall Status
Completed
CT.gov ID
NCT04058171
Collaborator
(none)
55
1
23
2.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Treadmill walking test

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
Actual Enrollment :
55 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Validation of a Treadmill Walking Test to Discriminate Neurogenic Claudication From Vascular Claudication
Actual Study Start Date :
May 1, 2018
Actual Primary Completion Date :
Mar 30, 2020
Actual Study Completion Date :
Mar 30, 2020

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Walking time [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

  1. 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]

    leg and back pain using a 0-10 points scale

  2. Walking impairment Questionnaire (WIQ) [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

  3. Tampa Scale of kinesiophobia [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

  4. Quality of life of participants [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

  5. Impact of pain, function and surgery satisfaction [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years and Older
Sexes Eligible for Study:
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Université du Québec à Trois-Rivières Trois-Rivières Quebec Canada G8Z 4M3

Sponsors and Collaborators

  • Université du Québec à Trois-Rivières

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Martin Descarreaux, Principal investigator, Université du Québec à Trois-Rivières
ClinicalTrials.gov Identifier:
NCT04058171
Other Study ID Numbers:
  • UQTR-2017-claudication
First Posted:
Aug 15, 2019
Last Update Posted:
Mar 9, 2021
Last Verified:
Mar 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Martin Descarreaux, Principal investigator, Université du Québec à Trois-Rivières
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 9, 2021