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

NCT ID: NCT04058171

Last Updated: 2021-03-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 55 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-05-01
• Study Completion Date: 2020-03-30

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.

Conditions

Spinal Stenosis Lumbar; Low Back Pain; Peripheral Artery Disease; Claudication

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

LSS group

Participants with a diagnosis of lumbar spinal stenosis

Treadmill walking test

Intervention Type: 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.

PAD group

Participants with a diagnosis of peripheral artery disease

Treadmill walking test

Intervention Type: 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.

LBP group

Participants with a diagnosis of non specific low back pain

Treadmill walking test

Intervention Type: 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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Université du Québec à Trois-Rivières

OTHER

Sponsor Role: lead

Responsible Party

Martin Descarreaux

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Martin Descarreaux, DC, PhD

Role: STUDY_DIRECTOR

Université du Québec à Trois-Rivières

Locations

Université du Québec à Trois-Rivières

Trois-Rivières, Quebec, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 34266463 (View on PubMed)

Other Identifiers

UQTR-2017-claudication

Identifier Type: -

Identifier Source: org_study_id