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

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Diagnostic Test: Treadmill walking test


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| LSS group<br>Participants with a diagnosis of lumbar spinal stenosis | Diagnostic Test: Treadmill walking test<br>* 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.<br>|
| PAD group<br>Participants with a diagnosis of peripheral artery disease | Diagnostic Test: Treadmill walking test<br>* 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.<br>|
| LBP group<br>Participants with a diagnosis of non specific low back pain | Diagnostic Test: Treadmill walking test<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Leg and back Pain (Visual analog scale) | 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) | 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 | 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 | 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 | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Walking capacity, Walking posture, Diagnostic test