Chronic Low Back Pain (non-specific, Uncomplicated)PERL3NCT06644053
Exploring Locomotion Behavior of Chronic Non-Specific Low Back Pain (cNSLBP) Patients While Walking Through Apertures in Different Configurations: Influence of Environmental and Social Factors.
An observational study of Chronic Low Back Pain (non-specific, Uncomplicated) and Walking, run by University of Rennes 2 at 1 site in France.
Trial summary
The biomechanical parameters studied in chronic non-specific low back pain (cNSLBP) 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 (non-specific, Uncomplicated), Walking
- What is being tested?
- Quantified analysis of walking during a crossing task through different horizontal openings
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 36 participants
- Where
- 1 siteFrance
- Study dates
- 14 Jul 2023to 8 Feb 2024
- 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: Patients with chronic non-specific low back pain are recruited as part of their medical follow-up in a medical centre in France.
Who may be able to join
- 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
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
The biomechanical parameters studied in chronic non-specific low back pain (cNSLBP) 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. This study focuses on a crossing task through different horizontal openings, varying the environmental context (two opening widths: one narrow and one wide) and the social context by placing an experimenter in the center of the two openings for some trials. The primary objective was to determine whether the cNSLBP affects the participant's decision to cross one of the two apertures as a function of the width of the aperture and the presence or absence of an experimenter. The secondary aim was twofold, firstly to study the kinematic variables of walking and secondly to assess the influence of pain perception variables on the choice of aperture crossed.
- Being tested
- Quantified analysis of walking during a crossing task through different horizontal openings
- Keywords
- Chronic Low back Pain, Crossing task paradigm, ecological paradigm, Assessment, Walking, Affordance
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 crossing task through different horizontal openingsBehavioural
Functional test that reproduce a task of daily living
| Study group | Role | What they receive |
|---|---|---|
| Chronic Non-Specific Low Back Pain participants | 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: Behavioral: Quantified analysis of walking during a crossing task through different horizontal openings | |
| Control group | Participant with no current or past chronic pain Receives: Behavioral: Quantified analysis of walking during a crossing task through different horizontal openings |
What is being measured
The primary outcome is the main question the study is designed to answer.
Critical threshold for motion adaptation
The critical threshold corresponds to the goal position at which individuals change their mode of action, i.e. the goal at which participants will cross the narrow aperture.
Measured: Clinical assessment at base line
Secondary outcomes (4)
Walking speed
Speed will calculate using the first derivative of the participant's position (location of the center of each participant at each point in time).
Measured: Clinical assessment at base line
Clearance distance
The clearance distance corresponds to the distance between the participant and the central obstacle forming the two apertures, i.e. a pole for the condition with modified environment and a human being for the conditions with modified social factors.
Measured: Clinical assessment at base line
Shoulder rotation
The shoulder rotation of each participant will be calculate from the horizontal coordinates of the two glenohumeral (GH) for the unobstructed straight lines and the experimental trials. The angle will be define in the horizontal plane between the GH line and the instantaneous walking direction at time where participants cross the aperture.
Measured: Clinical assessment at base line
Phase shift between the scapular and pelvic angles
The difference between the angles of rotation of the shoulders and pelvis in the horizontal plane of each participant will be calculated from the horizontal coordinates of the displacement of the markers positioned on the two glenohumeral and on the anterior superior iliac spine for the straight-line trials with no obstacles in the path and for the experimental trials.
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 posted16 Oct 2024
- Study start14 Jul 2023
- Primary completion8 Feb 2024
- Study completion8 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low Back Pain (non-specific, Uncomplicated)Studies 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
- 36 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06644053
- Sponsor's protocol ID
- 2023-A00870-45
- Acronym
- PERL3
- Status last verified
- Oct 2024
- First submitted
- 14 Oct 2024
- Last updated
- 16 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Locomotion Behavior of Chronic Non-Specific Low Back Pain (cNSLBP) Patients While Walking Through Apertures in Different Configurations: Influence of Environmental and Social Factors.
- ClinicalTrials.gov ID
- NCT06644053
- Acronym / sponsor ID
- PERL3 / 2023-A00870-45
- Keywords
- Chronic Low back Pain, Crossing task paradigm, ecological paradigm, Assessment, Walking, Affordance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of Rennes 2University, hospital or other
- Study start
- 14 Jul 2023 (actual)
- Primary completion
- 8 Feb 2024 (actual)
- Study completion
- 8 Feb 2024 (actual)
- First posted
- 16 Oct 2024 (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 chronic non-specific low back pain (cNSLBP) 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. This study focuses on a crossing task through different horizontal openings, varying the environmental context (two opening widths: one narrow and one wide) and the social context by placing an experimenter in the center of the two openings for some trials. The primary objective was to determine whether the cNSLBP affects the participant's decision to cross one of the two apertures as a function of the width of the aperture and the presence or absence of an experimenter. The secondary aim was twofold, firstly to study the kinematic variables of walking and secondly to assess the influence of pain perception variables on the choice of aperture crossed.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic Non-Specific Low Back Pain participants | – | Behavioral: Quantified analysis of walking during a crossing task through different horizontal openingsParticipants 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 | – | Behavioral: Quantified analysis of walking during a crossing task through different horizontal openingsParticipant 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
- Patients with chronic non-specific low back pain are recruited as part of their medical follow-up in a medical centre in France.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (0 listed)
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 crossing task through different horizontal openingsFunctional test that reproduce a task of daily living | Behavioural | Chronic Non-Specific Low Back Pain participants, Control group |
Primary outcome
Critical threshold for motion adaptation
Time frame: Clinical assessment at base line
The critical threshold corresponds to the goal position at which individuals change their mode of action, i.e. the goal at which participants will cross the narrow aperture.
4 secondary outcomes
Walking speed
Time frame: Clinical assessment at base line
Clearance distance
Time frame: Clinical assessment at base line
Shoulder rotation
Time frame: Clinical assessment at base line
Phase shift between the scapular and pelvic angles
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 16 Oct 2024.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 (non-specific, Uncomplicated) 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 1 inclusion and 0 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 16 Oct 2024. 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 for motion adaptation (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?
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 16 Oct 2024.