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

Completed

• Conditions: Spinal Stenosis Lumbar; Low Back Pain; Peripheral Artery Disease; Claudication
• Interventions: Diagnostic Test: Treadmill walking test

• Registration Number: NCT04058171
• Lead Sponsor: Université du Québec à Trois-Rivières

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.

Study Timeline

• Study Start: 2018-05-01
• Study First Submitted: 2019-08-09
• Study First Submitted QC: 2019-08-13
• Study First Posted: 2019-08-15
• Primary Completion: 2020-03-30
• Study Completion: 2020-03-30
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-08
• Last Update Posted: 2021-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PAD group	Treadmill walking test	Participants with a diagnosis of peripheral artery disease
LBP group	Treadmill walking test	Participants with a diagnosis of non specific low back pain
LSS group	Treadmill walking test	Participants with a diagnosis of lumbar spinal stenosis

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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 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
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
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.

Trial Locations

Locations (1)

Université du Québec à Trois-Rivières; 🇨🇦 Trois-Rivières, Quebec, Canada