[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100654915":3},{"organization":4,"outcomesModule":7,"designInfo":57,"detailedDescription":56,"studyPopulation":56,"armGroups":63,"interventions":73,"overallOfficials":78,"centralContacts":83,"locations":93,"responsibleParty":119,"collaborators":56,"id":122,"slug":123,"hasResults":124,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":128,"eligibilityCriteria":129,"healthyVolunteers":130,"sex":131,"minAge":132,"maxAge":133,"enrollmentInfo":134,"targetDuration":56,"studyType":137,"phases":138,"briefSummary":140,"conditions":141,"keywords":143,"overallStatus":151,"whyStopped":56,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":161},{"fullName":5,"class":6},"University of Rennes 2","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":56},[9],{"measure":10,"description":11,"timeFrame":12},"Change in muscle stiffness of the erector spinae and multifidus muscles between rest and after physical activity","Change in muscle stiffness, measured by shear modulus using shear-wave elastography, of the erector spinae and multifidus muscles, between rest and after physical activity.","As the study consists of a single session, the time frame is between the pre-walking-test and post-walking-test assessments.",[14,18,21,24,28,31,35,38,41,44,47,50,53],{"measure":15,"description":16,"timeFrame":17},"Ultrasound morphological measurements","Measurement of the cross-sectional area and thickness-as determined by ultrasound-of the erector spinae and multifidus muscles at rest.","Data were collected during the experimental session.",{"measure":19,"description":20,"timeFrame":17},"Electromyographic activity","Lumbar muscle activations during three-dimensional lumbar movements and while walking",{"measure":22,"description":23,"timeFrame":17},"Kinematics","The kinematics of the lumbopelvic-femoral complex (segmental velocity and acceleration, joint angles) during three-dimensional movements and while walking.",{"measure":25,"description":26,"timeFrame":27},"General data","Age, sex, height, weight, body mass index, and socioeconomic status are recorded.","Data were collected during the experimental session",{"measure":29,"description":30,"timeFrame":27},"Impact, effort, and sensations during the walking experience","Intensity of pain experienced, measured using a numerical rating scale at rest and during activity.\n\nPerceived exertion during walking on a treadmill, measured using the Borg CR-10 scale.\n\nHeart rate recorded using a Garmin® HRM heart rate monitor. Time, distance, and speed achieved during the walking task",{"measure":32,"description":33,"timeFrame":34},"Physical function","Patients' physical function is assessed using the Oswestry Disability Index (ODI).","Data from the questionnaire were collected during the experimental session, or shortly before (between 1 and 7 days beforehand)",{"measure":36,"description":37,"timeFrame":27},"Pain intensity and location","The intensity of pain experienced by participants on the day of the test, as measured by a numerical rating scale, and the location of the pain, as determined by the Pain Drawing test.",{"measure":39,"description":40,"timeFrame":34},"Daily impact of pain","The daily impact of pain (daily activities, work, leisure, anxiety and depression, social life) is assessed using the Dallas Self-Report Questionnaire (DRAD).",{"measure":42,"description":43,"timeFrame":34},"Quality of life health-related","Health-related quality of life is assessed using the SF-12 questionnaire (SF-12)",{"measure":45,"description":46,"timeFrame":34},"Physical activity and sedentary behavior","Participants' physical activity and sedentary behavior are assessed using the French version of the Global Physical Activity Questionnaire (GPAQ).",{"measure":48,"description":49,"timeFrame":34},"Kinesiophobia","Fear of physical injury related to movement is assessed using the Tampa Scale for Kinesiophobia (TSK).",{"measure":51,"description":52,"timeFrame":34},"Anxiety and depressive disorders","Screening for anxiety and depressive disorders is performed using the Hospital Anxiety and Depression Scale (HAD).",{"measure":54,"description":55,"timeFrame":27},"Validity of ultrasound measurements","The validity of ultrasound measurements is assessed by the intra-operator repeatability of ultrasound measurements.",null,{"allocation":58,"interventionModel":59,"interventionModelDescription":56,"primaryPurpose":60,"observationalModel":56,"timePerspective":56,"maskingInfo":61},"NON_RANDOMIZED","PARALLEL","BASIC_SCIENCE",{"masking":62,"maskingDescription":56,"whoMasked":56},"NONE",[64,70],{"label":65,"type":66,"description":67,"interventionNames":68},"Non-specific Chronic Low Back Pain participants","EXPERIMENTAL","Participants underwent a single assessment session including lumbar muscle ultrasound imaging, functional movement task analysis and a walking test. No therapeutic intervention was administered.",[69],"Other: Supervised Progressive Walking Test",{"label":71,"type":66,"description":67,"interventionNames":72},"Asymptomatic participants",[69],[74],{"type":6,"name":75,"description":76,"armGroupLabels":77,"otherNames":56},"Supervised Progressive Walking Test","After a warm-up period on the treadmill, the test involves walking, starting at a speed of 3 km\u002Fh and increasing the speed by 0.5 km\u002Fh every 2 minutes, up to a maximum of 7 km\u002Fh. The speed of 7 km\u002Fh is a target speed and is not mandatory.",[71,65],[79],{"name":80,"affiliation":81,"role":82},"Emilie Leblong, MD","Fondation Saint Helier, 35043 Rennes, France","PRINCIPAL_INVESTIGATOR",[84,89],{"name":85,"role":86,"phone":87,"phoneExt":56,"email":88},"Léo Denouël, PhD Student","CONTACT","+33 (0) 681768024","leo.denouel@univ-rennes2.fr",{"name":90,"role":86,"phone":91,"phoneExt":56,"email":92},"Armel Crétual, Professor","+33 (0) 290091588","armel.cretual@univ-rennes2.fr",[94],{"facility":5,"status":56,"city":95,"state":56,"zip":96,"country":97,"countryCode":98,"cosmosGeoPoint":99,"geoPoint":104,"contacts":105},"Rennes","35000","France","FR",{"type":100,"coordinates":101},"Point",[102,103],-1.67431,48.11109,{"lat":103,"lon":102},[106,107,108,111,113,115,116,118],{"name":85,"role":86,"phone":87,"phoneExt":56,"email":88},{"name":90,"role":86,"phone":91,"phoneExt":56,"email":92},{"name":109,"role":110,"phone":56,"phoneExt":56,"email":56},"Mathieu Ménard, PhD","SUB_INVESTIGATOR",{"name":112,"role":110,"phone":56,"phoneExt":56,"email":56},"Nolwenn Fougeron, PhD",{"name":114,"role":110,"phone":56,"phoneExt":56,"email":56},"Diane Haering, PhD",{"name":90,"role":110,"phone":56,"phoneExt":56,"email":56},{"name":117,"role":110,"phone":56,"phoneExt":56,"email":56},"Olivier Roze, MD",{"name":80,"role":82,"phone":56,"phoneExt":56,"email":56},{"type":82,"investigatorFullName":120,"investigatorTitle":121,"investigatorAffiliation":5,"oldNameTitle":56,"oldOrganization":56},"Léo Denouël","PhD Student","100654915","relationships-between-muscle-activity-soft-tissue-changes-and-movement-strategies-in-individuals-with-chronic-low-back-pain-100654915",false,"NCT07806253","Relationships Between Muscle Activity, Soft Tissue Changes, and Movement Strategies in Individuals With Chronic Low Back Pain","Study of the Relationships Between Muscle Activity, Soft Tissue Changes, and Movement Strategies in Individuals With Chronic Low Back Pain, in Order to Support Their Return to Sport and Physical Activity","E-LBP","Inclusion Criteria for CNSLBP participants:\n\n* Adult aged 18 to 65 years (inclusive)\n* Have freely given written informed consent\n* Present with pain located between the thoracolumbar junction and the inferior gluteal fold, with or without pain in one or both legs\n* This pain must have been present for more than 12 weeks, on a daily or near-daily basis (at least 4 days out of 7)\n* Participants must not be undergoing any treatment, or must have been on a stable analgesic treatment for at least 2 weeks prior to inclusion in the study\n* Must not have performed, in the 72 hours preceding participation in the study, any unusual intense physical activity (e.g., carrying a heavy load (\\> 25 kg), sporting activity) likely to transiently alter muscle activity or the mechanical properties of the tissues studied\n\nNon-inclusion criteria for CNSLBP participants :\n\n* Known contraindications or limitations to walking\n* Cardiovascular risk factors (uncontrolled high blood pressure, poorly controlled diabetes or diabetes with complications, severe untreated dyslipidemia), or heart disease contraindicating physical activity\n* Ongoing litigation following a workplace accident\n* Any form of specific low back pain, with an identified cause or secondary to an underlying condition, including in particular:\n* Pain related to a cancer diagnosis\n* Spinal cord or cauda equina symptoms (pyramidal signs, coordination disorders, motor or sensory deficits, sphincter disorders, etc.)\n* Pain following an infection (night sweats, fever, chills, intravenous drug abuse, immunodeficiency, recent surgery, urinary or skin infection, etc.)\n* Recent or pathological fractures (road traffic accidents, history of osteoporosis, chronic corticosteroid use, advanced age, unexplained weight loss, fatigue, history of cancer, etc.)\n* Inflammatory rheumatism (ankylosing spondylitis, rheumatoid arthritis, or other rheumatic diseases)\n* Vascular problems (cold feet, diminished peripheral arterial pulse, etc.)\n* Disabling radicular irradiation, at the investigator's discretion\n* Participants must not have undergone an intensive rehabilitation program within the last 3 months, nor received physiotherapy, manual therapy, acupuncture, or any other type of manual medicine or bodywork treatment outside their usual care, within the 4 weeks preceding inclusion\n* Severe, unstabilized psychiatric condition\n* Person presenting with a pathology or orthopedic disorder affecting locomotion\n* Recent spinal surgery (\\\u003C 3 months before the inclusion visit)\n* Systemic corticosteroid use, or corticosteroid injection at the lumbar spine, within the last 3 months\n* Muscle relaxant use in the week preceding the experiment\n\nInclusion criteria for asymptomatic participants :\n\n* Adult aged 18 to 65 years (inclusive)\n* Have freely given written informed consent\n* Person presenting no form of low back pain and matching the age and male-to-female ratio characteristics of the CNSLBP group\\*\n* In accordance with Article L1121-8-1 of the French Public Health Code, participants must be affiliated to, or beneficiaries of, a social security scheme\n* To ensure correspondence in terms of age and sex ratio between the CNSLBP group and the healthy group, the frequency of age and gender categories among CNSLBP participants will be used to build, by matching, the group of healthy participants.\n\nNon-inclusion criteria for asymptomatic participants :\n\n* Person reporting an ongoing chronic pain complaint or a history of significant chronic pain (≥ 4\u002F10 for at least 6 months) (HAS, 2019)\n* Person unable to perform the walking tasks studied without excessive discomfort or fatigue\n\nNon-inclusion criteria common to CNSLBP and asymptomatic participants :\n\n* Known contraindications or limitations to walking\n* Cardiovascular risk factors (uncontrolled high blood pressure, poorly controlled diabetes or diabetes with complications, severe untreated dyslipidemia), or heart disease contraindicating physical activity\n* Severe, unstabilized psychiatric condition\n* Person presenting with a pathology or orthopedic disorder affecting locomotion\n\n(\\*) Persons referred to in Articles L. 1121-5 to L. 1121-8 and L. 1121-12 of the French Public Health Code:\n\n* Pregnant, parturient, or breastfeeding woman\n* Person deprived of liberty by judicial or administrative decision\n* Person hospitalized without consent and not subject to a legal protection measure, and person admitted to a healthcare or social institution for purposes other than research\n* Person subject to an exclusion period for another study\n* Adult subject to a legal protection measure (guardianship, conservatorship, or court protection), or adult unable to express consent and not subject to a protection measure",true,"ALL","18 Years","65 Years",{"count":135,"type":136},60,"ESTIMATED","INTERVENTIONAL",[139],"NA","This study aims to explore, in patients with chronic non-specific low back pain (cnsLBP), the relationships between lumbar muscle activity, structural and morphological characteristics of the paraspinal muscles, and movement strategies, during a functional, ecological task: walking. To do this, we will compare a group of cnsLBP patients with a group of asymptomatic subjects, combining several types of measurements taken at different walking intensities: spinal kinematics (movement strategies), electromyographic activity of the lumbar muscles, and structural parameters of the paraspinal muscles (stiffness and thickness). The objective is twofold: first, to identify any significant differences between cnsLBP patients and healthy subjects on these combined parameters; second, to explore the interactions between these three dimensions (muscle activity, muscle structure, movement strategy) in order to better understand their relationships with pain and with how CNSLBP functions during physical activity. This multidimensional, ecological approach could also help identify subgroups within the cnsLBP population, reflecting the clinical heterogeneity already documented in the literature. Ultimately, the expected results will contribute to a better understanding of the biomechanical and neuromuscular mechanisms involved during physical activity in these patients, and will provide objective elements to help individualize physical activity recommendations according to each patient's profile.",[142],"Non-specific Chronic Low Back Pain",[142,144,145,146,147,148,149,150],"nscLBP","physical activity","walking","muscular activity","muscular stiffness","biomechanical assessment","movement Strategies","NOT_YET_RECRUITING","2026-10-08",{"date":154,"type":155},"2026-10-09","ACTUAL",{"date":157,"type":136},"2026-09",{"date":159,"type":136},"2028-09",{"name":5,"class":6},1]