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

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04058171
• Other study ID #: UQTR-2017-claudication
• Status: Completed
• Start date: May 1, 2018
• Est. completion date: March 30, 2020

Study information

• Verified date: March 2021
• Source: Université du Québec à Trois-Rivières
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: March 30, 2020
• Est. primary completion date: March 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Claudication
• Intermittent Claudication
• Low Back Pain
• Peripheral Arterial Disease
• Peripheral Artery Disease
• Spinal Stenosis
• Spinal Stenosis Lumbar

Intervention

Diagnostic Test:
• Treadmill 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.

Locations

Country	Name	City	State
Canada	Université du Québec à Trois-Rivières	Trois-Rivières	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Université du Québec à Trois-Rivières

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)