Chronic Low-back PainNCT05337995
Locomotion Strategies of Low Back Pain Patients
An observational study of Chronic Low-back Pain and Walking, run by University of Rennes 2 at 1 site in France.
Trial summary
The biomechanical parameters studied in non-specific chronic low back pain patients in a locomotion task have so far focused on straight line walking. Although locomotion is primarily an automated action composed of repetitive patterns allowing movement from one place to another, walkers must respond to the… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Low-back Pain, Walking
- What is being tested?
- Quantified analysis of walking during a task of passage through a horizontal opening
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2022to 15 Aug 2022
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: NSCLBP patients who do their medical follow-up in medical center in France
Who may be able to join
- Participants must have pain located between the thoracolumbar hinge and the lower gluteal fold, with or without pain in either leg.
- This pain must have been present for more than 12 weeks, on a daily or almost daily basis (at least 4 days out of 7)
- Participants must not be on any treatment or have been on stable analgesic treatment for at least 2 weeks prior to inclusion
- Participants must speak, read and understand French
- Participants must be between 18 and 65 years of age
- Participants must be able to understand simple commands and experimental instructions
Show all 10Show fewer
- Participants must have normal or corrected vision
- Participants must have given informed consent to participate in the study
- Participants must be enrolled in or receiving social security benefits
- Participants strictly meet the same inclusion and non-inclusion criteria as NSCLBP patients, but must not have ongoing chronic pain or a history of significant chronic pain (≥ 4/10 for at least 6 months). They are matched for age and gender. They must not have any pathologies that affect walking or posture. These individuals must be able to perform the studied movements without the appearance of discomfort or exaggerated fatigue.
Who cannot join
- Participants must not be pregnant or nursing mothers.
- Participants must not have cognitive or psychological impairments that are incompatible with compliance and/or understanding of the protocol (MMSE > 28)
- Participants must not be unable to understand informed consent, or be under guardianship or conservatorship
- Subjects must not already be participating in another research protocol involving the human subject or in parallel
- Participants must not be persons deprived of liberty by judicial or administrative decision
- Participants must not be under psychiatric care
Show all 14Show fewer
- The participants must not present neurological signs evoking a neurodegenerative disease responsible for walking disorders (parkinsonian syndrome, ...)
- The participants must not present warning signs (red flags) pointing to an underlying pathology requiring specific and/or urgent care such as
- Ongoing litigation following a work-related accident
- Pain related to a cancer diagnosis
- Associated spinal cord symptoms (pyramidal signs, coordination disorders, motor or sensory deficits, sphincter disorders, etc.)
- Pain following an infection (night sweats, fever, chills, intravenous drug abuse, immunodeficiency, recent surgery, urinary or skin infection, etc.)
- Recent or pathological fractures (traffic accidents, history of osteoporosis, chronic use of corticosteroids, advanced age, unexplained weight loss, fatigue, history of cancer, etc. )
- Vascular problems (cold feet, decreased peripheral arterial pulse, etc.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Locomotion Strategies of Patients With Chronic Non-Specific Low Back Pain During Aperture Crossing
The biomechanical parameters studied in non-specific chronic low back pain patients in a locomotion task have so far focused on straight line walking. Although locomotion is primarily an automated action composed of repetitive patterns allowing movement from one place to another, walkers must respond to the environmental demands.These modifications show a flexible and adaptive approach to the constraints of the environment. In this study, we are particularly interested in a task of passage through a horizontal opening, similar to a doorway, which is a standardized task that has shown its interest in the study of perceptual-motor co-ordinations. In particular, it allows to consider anthropometric and functional abilities of individuals, reflecting their action capacities.
- Conditions
- Chronic Low-back Pain, Walking
- Being tested
- Quantified analysis of walking during a task of passage through a horizontal opening
- Keywords
- Low Back Pain, Psychomotor Performance / physiology, Walking / physiology*, Adult, Humans, Motion Perception / physiology*
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quantified analysis of walking during a task of passage through a horizontal openingOther
Functional test that reproduce a task of daily living, similar to a doorway
| Study group | Role | What they receive |
|---|---|---|
| Non-Specific Low Back Pain patients | Participants must have pain located between the thoracolumbar hinge and the lower gluteal fold, with or without pain in either leg, present for more than 12 weeks, on a daily or almost daily basis (at least 4 days out of 7). Receives: Other: Quantified analysis of walking during a task of passage through a horizontal opening | |
| Control group | Participant with no current or past chronic pain Receives: Other: Quantified analysis of walking during a task of passage through a horizontal opening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Critical threshold
Defined as the width of opening making the transition between openings that it is possible or not to cross while walking without modification of the movement. We will then identify the trials, i.e. the door widths, where the participants have turned their shoulders. To do this, we will compare the shoulder angle observed during the doorway crossing with the average angle observed in the control conditions, corresponding to a straight line walk without any opening to cross.
Measured: Clinical assessment at base line
Secondary outcomes (4)
Phase shift between shoulder and pelvic angles in the transverse plane
Analysis of the difference between the scapular and pelvic angles in the transverse plane during aperture crossing
Measured: Clinical assessment at base line
Stability of the trunk
Analysis of the amplitude of the medio-lateral oscillation movements in the frontal plane during the task
Measured: Clinical assessment at base line
Step length
Analysis of the step length before the obstacle compared to the step length in the nominal walking condition (with no obstacle in the path)
Measured: Clinical assessment at base line
Walking speed
Analysis of the walking speed before the obstacle compared to the walking speed in the nominal walking condition (without obstacle on the path)
Measured: Clinical assessment at base line
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2022
- Study start1 Mar 2022
- Primary completion15 Aug 2022
- Study completion15 Aug 2022
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 Chronic Low-back PainStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rennes 2
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Agathe Bilhaut, University of Rennes 2
- Investigators
- Olivier Roze, MD, Principal investigator, clinique de la Sagesse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05337995
- Sponsor's protocol ID
- PERL
- Status last verified
- Apr 2023
- First submitted
- 30 Mar 2022
- Last updated
- 1 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bilhaut A, Menard M, Roze O, Cretual A, Olivier AH. Locomotion behavior of chronic Non-Specific Low Back Pain (cNSLBP) participants while walking through apertures. Gait Posture. 2023 Jul;104:140-146. doi: 10.1016/j.gaitpost.2023.06.015. Epub 2023 Jun 22.
PubMed 37419055
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Locomotion Strategies of Patients With Chronic Non-Specific Low Back Pain During Aperture Crossing
- ClinicalTrials.gov ID
- NCT05337995
- Acronym / sponsor ID
- PERL
- Conditions
- Chronic Low-back Pain, Walking
- Keywords
- Low Back Pain, Psychomotor Performance / physiology, Walking / physiology*, Adult, Humans, Motion Perception / physiology*
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Rennes 2University, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 15 Aug 2022 (actual)
- Study completion
- 15 Aug 2022 (actual)
- First posted
- 20 Apr 2022 (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 biomechanical parameters studied in non-specific chronic low back pain patients in a locomotion task have so far focused on straight line walking. Although locomotion is primarily an automated action composed of repetitive patterns allowing movement from one place to another, walkers must respond to the environmental demands.These modifications show a flexible and adaptive approach to the constraints of the environment. In this study, we are particularly interested in a task of passage through a horizontal opening, similar to a doorway, which is a standardized task that has shown its interest in the study of perceptual-motor co-ordinations. In particular, it allows to consider anthropometric and functional abilities of individuals, reflecting their action capacities.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-Specific Low Back Pain patients | – | Other: Quantified analysis of walking during a task of passage through a horizontal openingParticipants must have pain located between the thoracolumbar hinge and the lower gluteal fold, with or without pain in either leg, present for more than 12 weeks, on a daily or almost daily basis (at least 4 days out of 7). |
| Control group | – | Other: Quantified analysis of walking during a task of passage through a horizontal openingParticipant with no current or past chronic pain |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- NSCLBP patients who do their medical follow-up in medical center in France
Key inclusion criteria (10 listed)
- Participants must have pain located between the thoracolumbar hinge and the lower gluteal fold, with or without pain in either leg.
- This pain must have been present for more than 12 weeks, on a daily or almost daily basis (at least 4 days out of 7)
- Participants must not be on any treatment or have been on stable analgesic treatment for at least 2 weeks prior to inclusion
- Participants must speak, read and understand French
- Participants must be between 18 and 65 years of age
Key exclusion criteria (14 listed)
- Participants must not be pregnant or nursing mothers.
- Participants must not have cognitive or psychological impairments that are incompatible with compliance and/or understanding of the protocol (MMSE > 28)
- Participants must not be unable to understand informed consent, or be under guardianship or conservatorship
- Subjects must not already be participating in another research protocol involving the human subject or in parallel
- Participants must not be persons deprived of liberty by judicial or administrative decision
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 |
|---|---|---|
| Quantified analysis of walking during a task of passage through a horizontal openingFunctional test that reproduce a task of daily living, similar to a doorway | Other | Control group, Non-Specific Low Back Pain patients |
Primary outcome
Critical threshold
Time frame: Clinical assessment at base line
Defined as the width of opening making the transition between openings that it is possible or not to cross while walking without modification of the movement. We will then identify the trials, i.e. the door widths, where the participants have turned their shoulders. To do this, we will compare the shoulder angle observed during the doorway crossing with the average angle observed in the control conditions, corresponding to a straight line walk without any opening to cross.
4 secondary outcomes
Phase shift between shoulder and pelvic angles in the transverse plane
Time frame: Clinical assessment at base line
Stability of the trunk
Time frame: Clinical assessment at base line
Step length
Time frame: Clinical assessment at base line
Walking speed
Time frame: Clinical assessment at base line
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 1 May 2023.
- Derived from this study: PubMed 37419055Bilhaut A, Menard M, Roze O, Cretual A, Olivier AH. Locomotion behavior of chronic Non-Specific Low Back Pain (cNSLBP) participants while walking through apertures. Gait Posture. 2023 Jul;104:140-146. doi: 10.1016/j.gaitpost.2023.06.015. Epub 2023 Jun 22.
Related trials for Chronic Low-back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
Enrolling by invitation
Effects of 3-dimensional Versus Dynamic Myofascial Release Techniques With Lumbar Mobilization and Exercise Therapy Program in Chronic Non-specific Low Back Pain.
Chronic Non-Specific Low Back Pain, Myofascial Release
RecruitingPhase 2
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
Osteoarthritis, Knee, Diabetic Neuropathic Pain
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.
Olivier Roze, MD principal investigator
clinique de la Sagesse
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 Chronic Low-back Pain and Walking, run by University of Rennes 2 at 1 site in France.
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 10 inclusion and 14 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 1 May 2023. 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 France. 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?
Critical threshold (time frame: Clinical assessment at base line). 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 NCT05337995, 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 1 May 2023.