[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658047":3},{"organization":4,"outcomesModule":7,"designInfo":66,"detailedDescription":69,"studyPopulation":70,"armGroups":71,"interventions":65,"overallOfficials":65,"centralContacts":78,"locations":86,"responsibleParty":101,"collaborators":65,"id":105,"slug":106,"hasResults":107,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":111,"eligibilityCriteria":112,"healthyVolunteers":113,"sex":114,"minAge":115,"maxAge":116,"enrollmentInfo":117,"targetDuration":65,"studyType":120,"phases":65,"briefSummary":121,"conditions":122,"keywords":124,"overallStatus":89,"whyStopped":65,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":145},{"fullName":5,"class":6},"Aristotle University Of Thessaloniki","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":22,"otherOutcomes":65},[9,13,16,19],{"measure":10,"description":11,"timeFrame":12},"Power spectral density as measured via OPM-MEG","Differences in oscillatory activity between groups and subgroups. Difference is defined as statistical significance in the t-test comparison of the spectral power.","Baseline",{"measure":14,"description":15,"timeFrame":12},"Current density strength of the cortical activity as measured via OPM-MEG","Differences in cortical activity strength between groups and subgroups. Difference is defined as statistical significance in the t-test comparison of the current density strength as reconstructed via an inverse solution algorithm.",{"measure":17,"description":18,"timeFrame":12},"Cortical connectivity as measured via OPM-MEG","Differences in cortical connectivity between groups and subgroups. Difference is defined as statistical significance in the t-test comparison of a connectivity metric estimated from the cortical activity, as reconstructed via an inverse solution algorithm.",{"measure":20,"description":21,"timeFrame":12},"Network Topology as measured via OPM-MEG","Differences in network topology between groups and subgroups. Difference is defined as statistical significance in the t-test comparison of a graph measure estimated from the connectivity matrices of Outcome 3.",[23,26,29,32,35,38,41,44,47,50,53,56,59,62],{"measure":24,"description":25,"timeFrame":12},"Numerical Rating Pain Scale (NRPS)","Differences in pain intensity between groups and subgroups. This scale assesses subjective pain Intensity by selecting an integer from 0 to 10, where 0 represents complete absence of pain and 10 worst possible pain.",{"measure":27,"description":28,"timeFrame":12},"Tampa Scale of Kinesiophobia (TSK)","Differences in kinesiophobia between groups and subgroups. This questionnaire assesses kinesiophobia, i.e. the patient's fear of movement, physical activity, or re-inury due to pain. It includes 17 statements, where each statement is rated on a 4-point Likert scale, from 1 \"Strongly disagree\" to 4 \"Strongly agree\". Certain items, such as 4,8,12 and 16 are reversed scored. The total score is derived from the sum of all answers, with higher values indicating greater fear of movement.",{"measure":30,"description":31,"timeFrame":12},"Pain Catastrophizing Scale (PCS)","Differences in catastrophizing between groups and subgroups. This questionnaire measures pain catastrophizing i.e. the negative thoughts and excessive emotions experienced by the patient when in pain. It includes 13 statements. The patient rates each statement from 0 \"Not at all\" to 4 \"All the time\". The total score ranges from 0 to 52, with higher scores indicating higher levels of catastrophizing.",{"measure":33,"description":34,"timeFrame":12},"Athens Insomnia Scale (AIS)","Differences in sleep quality and the likelihood of insomnia between groups and subgroups. This scale assesses sleep quality and the likelihood of insomnia. It consists of 8 questions and each question has 4 response option from 0 \"no problem\u002Fadequate\" to 3 \"severe problem\u002Fvery inadequate\". Total scores range from 0 to 24, with higher scores indicating more severe insomnia problems.",{"measure":36,"description":37,"timeFrame":12},"Functional Disability measured via Modified Oswestry Disability Index (ODI)","Differences in level of functional disability between groups and subgroups. This questionnaire measures the level of functional disability and how lower back pain affects daily activities. It consists of 10 questions. Each includes 6 possible answers scored from 0 (least impact) to 5 (maximum impact). The final score is calculated as a percentage ( total score of answers\u002F Maximum possible score x 100), where 0% means no disability and 100% maximum possible disability.",{"measure":39,"description":40,"timeFrame":12},"Quality of life measured via World Health Organization Quality of Life-BREF (WHOQOL-BREF)","Differences in quality of life between groups and subgroups. This questionnaire assess quality of life across four domains (physical health, psychological well-being, social relationships and environment) via 26 questions on a 1-5 scale. Each domain yields a score transformed into a 0-100 scale, where higher values reflect better quality.",{"measure":42,"description":43,"timeFrame":12},"Distance walked during the 6-Minutes Walking Test (6-MWT)","Differences in distance walked during the 6-Minutes Walking Test between groups and subgroups. During the 6-Minutes Walking Test the total distance a person can walk on a flat, hard surface will be measured in meters (m).",{"measure":45,"description":46,"timeFrame":12},"Average Walking Speed (km\u002Fh)","Differences in average walking speed between groups and subgroups. Average walking speed (kilometers per hour) will be measured during the 6-Minutes Walking Test.",{"measure":48,"description":49,"timeFrame":12},"Cadence (step\u002Fmin)","Differences in cadence between groups and subgroups. Cadence will be calculated by the number of steps taken per minute (combined total of the two feet) and it will be measured during the 6-Minutes Walking Test.",{"measure":51,"description":52,"timeFrame":12},"Stride Length (cm)","Differences in stride length between groups and subgroups. Stride length will be calculated by the distance between two successive heel landings of the same foot and it will be measured during the 6-Minutes Walking Test.",{"measure":54,"description":55,"timeFrame":12},"Stance Time (ms and %)","Differences in stance time between groups and subgroups. Stance time will be calculated by the time during which the foot is in contact with the ground, standardized to be expressed as a percentage of the cycle time. It will be measured during the 6-Minutes Walking Test.",{"measure":57,"description":58,"timeFrame":12},"Swing Time (ms and %)","Differences in swing time between groups and subgroups. Swing time will be calculated by the time during which the foot is not in contact with the ground, standardized to be expressed as a percentage of the cycle time. It will be measured during the 6-Minutes Walking Test.",{"measure":60,"description":61,"timeFrame":12},"Double Support Time (%).","Differences in double support time between groups and subgroups. Double support time will be calculated by the percentage of the cycle during which both feet are in contact with the ground at the same time. It will be measured during the 6-Minutes Walking Test.",{"measure":63,"description":64,"timeFrame":12},"Symmetry Percentages (%) between the lower limbs","Differences in symmetry percentages between groups and subgroups. Symmetry expresses the congruence between the values obtained on the left and right foot for stance and swing time and determines whether one leg is used more than the other when walking. It will be measured during the 6-Minutes Walking Test.",null,{"allocation":65,"interventionModel":65,"interventionModelDescription":65,"primaryPurpose":65,"observationalModel":67,"timePerspective":68,"maskingInfo":65},"CASE_CONTROL","CROSS_SECTIONAL","Chronic low back pain (CLBP) is a leading healthcare challenge, with a significant proportion of cases classified as non-specific (NSLBP). A distinct subset of CLBP patients presents with neural mechanosensitivity, often clinically confirmed via neurodynamic tests such as the Slump test. While traditional neuroimaging has advanced our understanding of pain processing, conventional methods like EEG lack spatial resolution for deep brain structures, and traditional SQUID-MEG systems severely restrict patient movement.\n\nThis study leverages the novel technology of wearable Optically Pumped Magnetometers Magnetoencephalography (OPM-MEG), allowing for non-invasive, high-resolution recording of brain activity during movement.\n\nThe study protocol involves screening for eligibility, comprehensive demographic and medical history collection, and a physical\u002Fneurological examination (including reflex, sensory, and muscle strength testing, alongside Straight Leg Raise and Slump tests). Participants complete validated psychometric questionnaires evaluating pain intensity, kinesiophobia, pain catastrophizing , sleep quality, functional disability, and quality of life. Furthermore, participants undergo a standardized 6-minute walk test using smart digital insoles to record spatiotemporal parameters, kinematic variables, and composite gait biomarkers.\n\nParticipants, also, perform a controlled, movement-evoked pain task (modified Slump-based knee extension\u002Fflexion protocol) designed to elicit mild, transient symptoms and a resting state recording.\n\nThe primary objectives are to map and compare resting-state and movement-evoked cortical oscillations, current density, and functional connectivity between CLBP patients and healthy controls, and to assess the predictive value of neurophysiological markers on psychological burden. Secondary objectives include identifying distinct pain phenotypes by integrating biomechanical, psychophysiological, and neural data.","Patients and healthy controls will be recruited through referrals from private physical therapy clinics and medical centers in Thessaloniki, as well as through an open call for expressions of interest to the broader community for voluntary participation.",[72,75],{"label":73,"type":65,"description":74,"interventionNames":65},"CLBP","Adults aged 18-45 with chronic low back pain (\\>3 months) and neural mechanosensitivity.",{"label":76,"type":65,"description":77,"interventionNames":65},"HC","Healthy volunteers without pain.",[79,84],{"name":80,"role":81,"phone":82,"phoneExt":65,"email":83},"Natalia M Keklikoglou, MSc Student","CONTACT","2310999310","nkeklik@ece.auth.gr",{"name":85,"role":81,"phone":65,"phoneExt":65,"email":65},"Panagiotis D Bamidis, PhD",[87],{"facility":88,"status":89,"city":90,"state":91,"zip":92,"country":93,"countryCode":94,"cosmosGeoPoint":95,"geoPoint":100,"contacts":65},"Laboratory of Medical Physics and Digital Innovation, AUTH","RECRUITING","Thessaloniki","Central Macedonia","54124","Greece","GR",{"type":96,"coordinates":97},"Point",[98,99],22.93493,40.64072,{"lat":99,"lon":98},{"type":102,"investigatorFullName":103,"investigatorTitle":104,"investigatorAffiliation":5,"oldNameTitle":65,"oldOrganization":65},"PRINCIPAL_INVESTIGATOR","Panos Bamidis","Professor","100658047","pain-assessment-through-integrated-neurophysiology-and-multidimensional-profiling-100658047",false,"NCT07846163","Pain Assessment Through Integrated Neurophysiology and Multidimensional Profiling","Exploring Pain: An OPM-MEG, Biomechanical, and Biopsychosocial Analysis in Chronic Low Back Pain","PAIN-MAP","Inclusion Criteria (Group of Chronic Low Back Pain Patients):\n\n* 18-45 years old\n* Non-specific low back pain\n* Duration of pain \\> 3 months\n* Positive SLUMP test\n\nInclusion Criteria (Group of Healthy Control Participants):\n\n* 18-45 years old\n* Healthy\u002F free of pain\n\nExclusion Criteria (Common for both groups):\n\n* History of spinal injury\n* History of cancer\n* Bone metabolic diseases\n* Inflammatory conditions (spondyloarthritis or systemic inflammatory diseases)\n* Spondylolistethis\n* Presence of neurological deficits suggesting active nerve root compression\u002Fradiculopathy (pathological of tendon reflexes, sensitivity and muscle strength)\n* Diagnosed neurodegenerative\u002Fneurological disorders or epilepsy\n* Psychiatric disorders\n* High irritability, according to Severity, Irritability, Nature, Stage, and Stability- SINSS pain assessment tool.\n* Claustrophobia due to the measurement process inside the shielded room\n* Electrical\u002Felectronic implants(e.g. pacemakers), metallic surgical materials (e.g. plates, stent) and dental and orthodontic metallic materials (e.g. braces).",true,"ALL","18 Years","45 Years",{"count":118,"type":119},60,"ESTIMATED","OBSERVATIONAL","This observational case-control study aims to investigate the central neurophysiological mechanisms underlying non-specific chronic low back pain (CLBP) with neural mechanosensitivity, with wearable Optically Pumped Magnetometers Magnetoencephalography (OPM-MEG). The study evaluates brain activity dynamics at rest and during controlled movement-evoked pain. Additionally, it explores the relationship between cortical processing markers and multidimensional biopsychosocial profiles (including pain intensity, kinesiophobia, catastrophizing, sleep quality, and functional disability) and gait adaptaions in adults with CLBP aged 18 to 45 compared to healthy pain-free controls.",[123],"Chronic Low-back Pain (cLBP)",[125,126,127,128,129,130,131,132,133,134,135],"OPM-MEG","Optically Pumped Magnetometers","Magnetoencephalography","Chronic Low Back Pain","Pain","Neural Mechanosensitivity","Biomechanics","Gait Analysis","SLUMP test","Kinesiophobia","Catastrophizing","2026-09-22",{"date":138,"type":139},"2026-09-29","ACTUAL",{"date":141,"type":139},"2026-09-07",{"date":143,"type":119},"2027-12",{"name":5,"class":6},1]