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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04058171
Enrollment
55
Registered
2019-08-15
Start date
2018-05-01
Completion date
2020-03-30
Last updated
2021-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Claudication, Low Back Pain, Peripheral Artery Disease, Spinal Stenosis Lumbar

Keywords

Walking capacity, Walking posture, Diagnostic test

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.

Interventions

DIAGNOSTIC_TESTTreadmill 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.

Sponsors

Université du Québec à Trois-Rivières
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
Walking timeTime 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

MeasureTime frameDescription
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 restleg and back pain using a 0-10 points scale
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
Tampa Scale of kinesiophobiaday 1, before the walking test (this is a transversal study)Questionnaire, Total score range from 17 to 68, Higher score indicate a worst outcome
Quality of life of participantsday 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
Impact of pain, function and surgery satisfactionday 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.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 22, 2026