NCT04058171

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2018

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

August 9, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 15, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2020

Completed
Last Updated

March 9, 2021

Status Verified

March 1, 2021

Enrollment Period

1.9 years

First QC Date

August 9, 2019

Last Update Submit

March 8, 2021

Conditions

Spinal Stenosis LumbarLow Back PainPeripheral Artery DiseaseClaudication

Keywords

Walking capacityWalking postureDiagnostic test

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • 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

  • Walking impairment Questionnaire (WIQ)

    day 1, before the walking test (this is a transversal study)

  • Tampa Scale of kinesiophobia

    day 1, before the walking test (this is a transversal study)

  • Quality of life of participants

    day 1, before the walking test (this is a transversal study)

  • Impact of pain, function and surgery satisfaction

    day 1, before the walking test (this is a transversal study)

Study Arms (3)

LSS group

Participants with a diagnosis of lumbar spinal stenosis

Diagnostic Test: Treadmill walking test

PAD group

Participants with a diagnosis of peripheral artery disease

Diagnostic Test: Treadmill walking test

LBP group

Participants with a diagnosis of non specific low back pain

Diagnostic Test: Treadmill walking test

Interventions

Treadmill walking testDIAGNOSTIC_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 groupLSS groupPAD group

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with neurogenic or vascular claudication

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Université du Québec à Trois-Rivières

Trois-Rivières, Quebec, G8Z 4M3, Canada

Location

Related Publications (1)

  • 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.

    PMID: 34266463DERIVED

MeSH Terms

Conditions

Low Back PainPeripheral Arterial DiseaseIntermittent Claudication

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsAtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular Diseases

Study Officials

  • Martin Descarreaux, DC, PhD

    Université du Québec à Trois-Rivières

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

August 9, 2019

First Posted

August 15, 2019

Study Start

May 1, 2018

Primary Completion

March 30, 2020

Study Completion

March 30, 2020

Last Updated

March 9, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)