Spinal Stenosis LumbarNCT04058171
Validation of a Treadmill Walking Test to Discriminate Neurogenic Claudication From Vascular Claudication
An observational study of Spinal Stenosis Lumbar and Low Back Pain, run by Université du Québec à Trois-Rivières at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Spinal Stenosis Lumbar, Low Back Pain, Peripheral Artery Disease
- What is being tested?
- Treadmill walking test
- How many people
- 55 participants
- Where
- 1 siteCanada
- Study dates
- 1 May 2018to 30 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with neurogenic or vascular claudication
Who may be able to join
- 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
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- 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
Who cannot join
- Foraminal stenosis
- Spinal stenosis with predominant back pain
- Symptomatic disc herniation
- Previous lumbar surgery
- Previous vascular surgery
- Type 1 diabetes
Show all 9Show fewer
- Knee or hip osteoarthritis
- Hip or knee arthroplasty
- Inability to provide free and informed consent
Trial locations and contacts
1 site in 1 country.
Canada1 site
Université du Québec à Trois-Rivières
Trois-Rivières, Quebec, G8Z 4M3
About this study
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.
Read the 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.
- Being tested
- Treadmill walking test
- Keywords
- Walking capacity, Walking posture, Diagnostic test
- Medical subject headings
- Low Back Pain, Peripheral Arterial Disease, Intermittent Claudication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| LSS group | Participants with a diagnosis of lumbar spinal stenosis Receives: Diagnostic Test: Treadmill walking test | |
| PAD group | Participants with a diagnosis of peripheral artery disease Receives: Diagnostic Test: Treadmill walking test | |
| LBP group | Participants with a diagnosis of non specific low back pain Receives: Diagnostic Test: Treadmill walking test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Walking time
Measured: 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)
leg and back pain using a 0-10 points scale
Measured: Before the walking test, through the walking test completion, at 2:30 minutes of rest, at 5 minutes of rest
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
Measured: day 1, before the walking test (this is a transversal study)
Tampa Scale of kinesiophobia
Questionnaire, Total score range from 17 to 68, Higher score indicate a worst outcome
Measured: day 1, before the walking test (this is a transversal study)
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
Measured: day 1, before the walking test (this is a transversal study)
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.
Measured: day 1, before the walking test (this is a transversal study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2019
- Study start1 May 2018
- Primary completion30 Mar 2020
- Study completion30 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Stenosis LumbarStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université du Québec à Trois-Rivières
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin Descarreaux, Université du Québec à Trois-Rivières
- Investigators
- Martin Descarreaux, DC, PhD, Study director, Université du Québec à Trois-Rivières
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04058171
- Sponsor's protocol ID
- UQTR-2017-claudication
- Status last verified
- Mar 2021
- First submitted
- 9 Aug 2019
- Last updated
- 9 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 34266463
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Treadmill Walking Test to Discriminate Neurogenic Claudication From Vascular Claudication
- ClinicalTrials.gov ID
- NCT04058171
- Acronym / sponsor ID
- UQTR-2017-claudication
- Keywords
- Walking capacity, Walking posture, Diagnostic test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Université du Québec à Trois-RivièresUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 15 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LSS group | – | Diagnostic Test: Treadmill walking testParticipants with a diagnosis of lumbar spinal stenosis |
| PAD group | – | Diagnostic Test: Treadmill walking testParticipants with a diagnosis of peripheral artery disease |
| LBP group | – | Diagnostic Test: Treadmill walking testParticipants with a diagnosis of non specific low back pain |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with neurogenic or vascular claudication
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (9 listed)
- Foraminal stenosis
- Spinal stenosis with predominant back pain
- Symptomatic disc herniation
- Previous lumbar surgery
- Previous vascular surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treadmill walking testParticipants 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. | Diagnostic test | LBP group, LSS group, PAD group |
Primary outcome
Walking time
Time frame: 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
5 secondary outcomes
Leg and back Pain (Visual analog scale)
Time frame: Before the walking test, through the walking test completion, at 2:30 minutes of rest, at 5 minutes of rest
Walking impairment Questionnaire (WIQ)
Time frame: day 1, before the walking test (this is a transversal study)
Tampa Scale of kinesiophobia
Time frame: day 1, before the walking test (this is a transversal study)
Quality of life of participants
Time frame: day 1, before the walking test (this is a transversal study)
Impact of pain, function and surgery satisfaction
Time frame: day 1, before the walking test (this is a transversal study)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2021.
- Derived from this study: PubMed 34266463Houle 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Descarreaux, DC, PhD study director
Université du Québec à Trois-Rivières
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Stenosis Lumbar and Low Back Pain, run by Université du Québec à Trois-Rivières at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Walking time (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04058171, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2021.