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NCT Number: NCT04058171

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

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.

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Key information

Conditions

Spinal Stenosis Lumbar Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Back Pain Cardiovascular Diseases Claudication Intermittent Claudication Low Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Peripheral Arterial Disease Peripheral Artery Disease Peripheral Vascular Diseases Signs and Symptoms Vascular Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Université du Québec à Trois-Rivières

Trois-Rivières, Quebec, G8Z 4M3, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Treadmill walking test

Diagnostic 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.

Primary outcomes

  1. 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

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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.

Sponsors and collaborators

Lead sponsor

Université du Québec à Trois-Rivières

Other

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Aug 15, 2019
Registry last updated
Mar 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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