An observational study in Chronic Low Back Pain (non-specific, Uncomplicated) and Walking, sponsored by University of Rennes 2. Completed at 1 site in France. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-16.
Sponsored by University of Rennes 2 · Observational
Among 114 studies in Low Back Pain with a site in France — 31 open to participants now, 34 under way, 5 of them phase 3. Low Back Pain · France.
Among the 114 studies in Low Back Pain with a site in France, this one is the 23rd largest by enrollment of the 35 observational ones, is one of 12 that started in 2023, is one of 35 observational ones, and was the 93rd registered.
2,922 studies on the registry are indexed under Low Back Pain; 580 are open to participants now.
This study's enrollment of 36 is below the median of 100 across 481 observational studies indexed under Low Back Pain.
Browse Low Back Pain studies →31 of the 114 studies in Low Back Pain with a site in France are open now, in 1 country. Each count lists the studies.
Of the 333 Low Back Pain studies recruiting now, 92 (28%) set no upper age limit and 211 (63%) stop at 75 or younger; 8 take children under 18; 46 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · healthy volunteers too.
The full table on the hub →114 studies; the count open now beside each. This study's row is marked.
First in 2003; this study’s year is marked. 12 started in 2023.
Median enrollment 82 across the 79 interventional studies, 80 across the 35 observational. Of the 68 that completed or were terminated, 4 (6%) have results posted.
11 of 114 have an industry lead sponsor. The 10 most frequent:
University of Rennes 2 is the lead sponsor of 12 studies on the registry; 3 are open to participants now.
University of Rennes 2 has 3 studies filed under Low Back Pain — fewer than ten, so there is no comparison to draw.
10 of the studies in Low Back Pain with a site in France that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04075539Phase 3Assistance Publique - Hôpitaux de ParisHome-based Cycling for People With Lumbar Spinal Stenosis | 2027-06 |
| NCT05511012University Hospital, BrestDoes the Therapist's Assessment of Movement Control in Low Back Pain Patients Correspond to an Objective Kinematic Modification | 2026-12-15 |
| NCT06347328Centre Hospitalier Universitaire de NiceThe Benefits of Posterior Joint Infiltration in Chronic Low Back Pain | 2027-01 |
| NCT07327554University Hospital, MontpellierAssessment of the Evolution of Lumbar Spine Movement Fluidity Using Xsens Inertial Sensors in Subjects With Chronic Low Back Pain Before and After Rehabilitation | 2027-04 |
| NCT05231265Centre Hospitalier Universitaire de NīmesEffect of Lumbar Surgery on Complexity During a Walking Task in Chronic Low Back Pain | 2027-04 |
Among the 114 studies in Low Back Pain with a site in France, from their registry updates:
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.
Patients with chronic non-specific low back pain are recruited as part of their medical follow-up in a medical centre in France.
Inclusion Criteria Non Specific Chronic Low Back Pain patients:
Exclusion Criteria Non Specific Chronic Low Back Pain patients:
Inclusion and Exclusion Criteria of control group :
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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Behavioral: Quantified analysis of walking during a crossing task through different horizontal openings
Participant with no current or past chronic pain
Behavioral: Quantified analysis of walking during a crossing task through different horizontal openings
Functional test that reproduce a task of daily living
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.
Time frame: Clinical assessment at base line
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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Clinical assessment at base line
Pain intensity
Pain intensity reflects the overall magnitude of the patient's perceived pain experience. The investigators will assess this variable using a visual analogue scale (VAS) in paper format. The VAS is represented by a 100 mm long horizontal line with descriptors at both ends: on the left "no pain" and on the right "worst pain imaginable". The patient must then draw a mark on the line corresponding to his or her pain experience. "0" corresponds to "no pain" and "10" corresponds to "worst pain imaginable".
Time frame: Clinical assessment at base line
Levels of anxiety and depression
Anxiety refers to fear, extreme worrying and hyperarousal symptoms. Depression refers to negative mood, loss of self-confidence, loss of motivation and pleasure. The investigators will use these measures using the Hospital Anxiety Depression Scale (HADS). This tool consists of 14 items scored from 0 to 3. Seven questions relate to anxiety (Total A) and 7 questions to the depressive dimension (Total D), resulting in two scores with a maximum total of 21 each. The higher the score, the more anxiety or depression the person has.
Time frame: Clinical assessment at base line
Pain Catastrophizing
Catastrophizing refers to the cognitive process in which anxious patients dwell on the most negative consequences and refers here to the interpretation of pain as extremely threatening. The investigators will use the Pain Catastrophizing Scale (PCS) to assess three dimensions: rumination, amplification and helplessness. This scale consists of 13 items scored from 0 (not at all) to 4 (all the time) with a maximum score of 52. The higher the score, the greater the level of catastrophisation.
Time frame: Clinical assessment at base line
Kinesiophobia
Fear of movement is characterized by pain-related fears and anxieties that often result in avoidance of movement that could cause or worsen an injury. The investigators will use the Tampa Scale Kinesiophobia (TSK). This scale consists of 17 items rated from 1 (strongly disagree) to 4 (strongly agree) with a maximum score of 68. The higher the score, the greater the level of kinesiophobia.
Time frame: Clinical assessment at base line
Psychological Inflexibility in Pain
Psychological flexibility measures psychological functioning in phase (in fusion) with the pain or whether the patient has certain degrees of freedom from it. The investigators will use the Psychological Inflexibility in Pain Scale (PIPS) allowing to assess two factors: avoidance and cognitive fusion. This scale consists of 16 items with a scale of 1 (never true) to 7 (always true). The higher the score, the greater the level of psychological inflexibility.
Time frame: Clinical assessment at base line
Fear Avoidance Beliefs
Fear and avoidance beliefs reflect patients' pain avoidance behaviors. The investigators will use the Fear Avoidance Beliefs Questionnaire (FABQ) to assess two subscales: beliefs about work and beliefs about physical activity. The questionnaire consists of 16 items scored from 0 (absolutely disagree with the sentence) to 6 (completely agree with the sentence). The maximum score for beliefs about work is 42 and the maximum score for beliefs about physical activity is 24. The higher the score, the greater the level of beliefs.
Time frame: Clinical assessment at base line
Physical functioning
Physical functioning refers to the impact on the patient's ability to perform daily physical activities necessary to meet basic needs, ranging from self-care to more complex activities that require a combination of skills. The investigators will use the Roland Morris Disability Questionnaire (RMDQ). This questionnaire has 24 items with a maximum score of 24. The higher the score, the more functional disabilities the person has.
Time frame: Clinical assessment at base line
Quality of life assessment
Quality of life refers to the impact on the physical, psychological, and social domains of health, considered as distinct domains that are influenced by a person's experiences, beliefs, expectations, and perceptions. The investigators will use the EuroQol 5 Dimension questionnaire (EQ-5D) allowing for the assessment of five dimensions: mobility, ability to care for oneself, usual work, home, and leisure activities, pain/discomfort, anxiety, and depression. Five degrees of severity in ascending order are used to assess each dimension: "no problems" to "total disability" for items that assess ability, and "no problem" to "extreme" for the other items. The higher the score, the lower the level of quality of life.
Time frame: Clinical assessment at base line
Plan to share: No — There is not a plan to make IPD available.
No publications or documents are linked to this record.
Ran from Jul 2023 to primary completion in Feb 2024, 6 months.
Of 175 non-industry observational studies under Low Back Pain, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 48. This study's 6 months is below that.
Counting every sponsor, half of 185 studies reached it within 24 months; a quarter within 10 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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University of Rennes 2