Clinical trial NCT04058171: Validation of a Treadmill Walking Test to Discriminate Neurogenic Claudication From Vascular Claudication
Official title: Validation of a Treadmill Walking Test to Discriminate Neurogenic Claudication From Vascular Claudication
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Stenosis Lumbar
Low Back Pain
Peripheral Artery Disease
Claudication
Keywords: Walking capacity
Walking posture
Diagnostic test
Lead sponsor: Université du Québec à Trois-Rivières
Sponsor class: OTHER
First posted: 2019-08-15
Enrollment: 55
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with neurogenic or vascular claudication

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.

Eligibility criteria: 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

Primary outcomes:
measure: Walking time
timeFrame: 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:
measure: Leg and back Pain (Visual analog scale)
timeFrame: Before the walking test, through the walking test completion, at 2:30 minutes of rest, at 5 minutes of rest
measure: Walking impairment Questionnaire (WIQ)
timeFrame: day 1, before the walking test (this is a transversal study)
measure: Tampa Scale of kinesiophobia
timeFrame: day 1, before the walking test (this is a transversal study)
measure: Quality of life of participants
timeFrame: day 1, before the walking test (this is a transversal study)
measure: Impact of pain, function and surgery satisfaction
timeFrame: day 1, before the walking test (this is a transversal study)
Other outcomes:
Locations:
city: Trois-Rivières
country: Canada
facility: Université du Québec à Trois-Rivières
state: Quebec
Study officials:
affiliation: Université du Québec à Trois-Rivières
name: Martin Descarreaux, DC, PhD
role: STUDY_DIRECTOR
References:
citation: Houle M, O'Shaughnessy J, Tetreau C, Chatillon CE, Marchand AA, Descarreaux M. Comparison of walking variations during treadmill walking test between neurogenic and vascular claudication: a crossover study. Chiropr Man Therap. 2021 Jul 15;29(1):24. doi: 10.1186/s12998-021-00382-5.