[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657260":3},{"organization":4,"outcomesModule":7,"designInfo":39,"detailedDescription":38,"studyPopulation":38,"armGroups":47,"interventions":60,"overallOfficials":38,"centralContacts":70,"locations":38,"responsibleParty":76,"collaborators":80,"id":83,"slug":84,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":85,"sex":91,"minAge":92,"maxAge":93,"enrollmentInfo":94,"targetDuration":38,"studyType":97,"phases":98,"briefSummary":100,"conditions":101,"keywords":38,"overallStatus":103,"whyStopped":38,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":38},{"fullName":5,"class":6},"University of Chile","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":38},[9,13],{"measure":10,"description":11,"timeFrame":12},"Pain Intensity","Pain intensity will be assessed using a 100-mm Visual Analog Scale (VAS), ranging from 0 mm (\"no pain\") to 100 mm (\"worst pain imaginable\"). Higher scores indicate greater pain intensity.","Baseline and immediately after the 6-week intervention",{"measure":14,"description":15,"timeFrame":12},"Low Back Pain-Related Disability","Disability will be assessed using the validated Spanish version of the Roland-Morris Disability Questionnaire (RMDQ). The questionnaire consists of 24 items scored as 0 or 1, resulting in a total score ranging from 0 to 24. Higher scores indicate greater low back pain-related disability.",[17,20,23,26,29,32,35],{"measure":18,"description":19,"timeFrame":12},"Heart Rate Variability","Heart rate variability (HRV) will be assessed using time- and frequency-domain measures, including high-frequency (HF) power, low-frequency (LF) power, and the root mean square of successive differences (RMSSD). HRV will be assessed at rest and during anticipation of the lifting task.",{"measure":21,"description":22,"timeFrame":12},"Skin Conductance","Skin conductance will be assessed using the MED-STORM PAIN MONITOR. The number of fluctuations in skin conductance per second (NFSC) will be recorded using electrodes placed on the palms of the hands. Skin conductance will be assessed at rest and during anticipation of the lifting task, with higher NFSC values indicating greater sympathetic reactivity.",{"measure":24,"description":25,"timeFrame":12},"Trunk Muscle Co-contraction During the Lifting Task","Surface electromyography (sEMG) will be recorded from the external oblique, rectus abdominis, erector spinae, and multifidus during the lifting task. Muscle co-contraction will be calculated from the area of overlap between paired muscle activation profiles, resulting in values ranging from 0 to 1, where 1 represents complete overlap.",{"measure":27,"description":28,"timeFrame":12},"Kinesiophobia","Kinesiophobia will be assessed using the Spanish version of the 11-item Tampa Scale for Kinesiophobia (TSK-11). Total scores range from 11 to 44, with higher scores indicating greater kinesiophobia.",{"measure":30,"description":31,"timeFrame":12},"Task-Specific Fear","Fear related specifically to the lifting task will be assessed using an 11-point Numerical Rating Scale ranging from 0 to 10, with higher scores indicating greater task-specific fear.",{"measure":33,"description":34,"timeFrame":12},"Pain Catastrophizing","Pain catastrophizing will be assessed using the 13-item Pain Catastrophizing Scale (PCS). Each item is scored from 0 to 4, resulting in a total score ranging from 0 to 52. Higher scores indicate greater pain catastrophizing",{"measure":36,"description":37,"timeFrame":12},"Intolerance of Uncertainty","Intolerance of uncertainty will be assessed using the 27-item Intolerance of Uncertainty Scale. Each item is rated on a 5-point scale from 1 (\"not at all characteristic of me\") to 5 (\"entirely characteristic of me\"), with higher scores indicating greater intolerance of uncertainty.",null,{"allocation":40,"interventionModel":41,"interventionModelDescription":38,"primaryPurpose":42,"observationalModel":38,"timePerspective":38,"maskingInfo":43},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":44,"maskingDescription":38,"whoMasked":45},"SINGLE",[46],"OUTCOMES_ASSESSOR",[48,54],{"label":49,"type":50,"description":51,"interventionNames":52},"Pain Science Education Plus Graded Exposure","EXPERIMENTAL","Participants will receive a 6-week program combining pain science education with graded exposure to movement. Pain science education will be delivered once weekly through a hybrid format, including group, individual online, and asynchronous sessions. Participants will also receive one individual, in-person graded exposure session per week for 6 weeks. Graded exposure will be individualized according to activities that participants fear or avoid, with progressive modification of load, speed, or range of motion.",[53],"Behavioral: Pain Science Education Plus Graded Exposure",{"label":55,"type":56,"description":57,"interventionNames":58},"Usual Physical Therapy","ACTIVE_COMPARATOR","Participants will receive usual physical therapy for 6 weeks. The intervention will include one group-based educational session on low back pain and one in-person physical therapy session per week for 6 weeks. Physical therapy will include stretching, thermotherapy, electrotherapy, and conventional core stabilization exercises. Participants will also be instructed to perform trunk stabilization exercises at home three days per week.",[59],"Other: Usual Physical Therapy",[61,67],{"type":62,"name":49,"description":63,"armGroupLabels":64,"otherNames":65},"BEHAVIORAL","Participants will receive six 30-minute pain science education sessions over 6 weeks, including two group sessions, two individual online sessions, and two asynchronous sessions. Education will address pain neurobiology, the relationship between pain and tissue damage, pain modulation, cognitive and emotional influences on pain, neuroplasticity, self-management, and the role of movement. Participants will also receive six weekly individual, in-person graded exposure sessions. Feared or avoided functional activities will be identified and hierarchically ordered, and participants will be gradually exposed to these activities. Progression will be individualized by modifying load, speed, or range of motion.",[49],[66],"Pain Neuroscience Education Plus Graded Exposure",{"type":6,"name":55,"description":68,"armGroupLabels":69,"otherNames":38},"Participants will receive one 30-minute group educational session addressing mechanical causes of low back pain, spinal anatomy, physiology and biomechanics, self-care and ergonomics, lifting techniques, and therapeutic exercise. Participants will also receive one in-person physical therapy session per week for 6 weeks, including stretching, thermotherapy, electrotherapy, and conventional core stabilization exercises (3-4 sets of 20-30 repetitions). Participants will be instructed to perform trunk stabilization exercises at home three days per week.",[55],[71],{"name":72,"role":73,"phone":74,"phoneExt":38,"email":75},"Rodrigo Núñez-Cortés, PhD","CONTACT","928777254","r_nunez@uchile.cl",{"type":77,"investigatorFullName":78,"investigatorTitle":79,"investigatorAffiliation":5,"oldNameTitle":38,"oldOrganization":38},"PRINCIPAL_INVESTIGATOR","RODRIGO NUNEZ","Principal Investigator",[81],{"name":82,"class":6},"Agencia Nacional de Investigación y Desarrollo","100657260","pain-science-education-and-graded-exposure-for-chronic-low-back-pain-100657260",false,"NCT07836946","Pain Science Education and Graded Exposure for Chronic Low Back Pain","Effect of Pain Science Education Combined With Graded Exposure to Movement on Physiological Stress Responses and Motor Performance in Patients With Chronic Low Back Pain","PSE-GEM","Inclusion Criteria:\n\n* Men and women aged 18 to 60 years.\n* Diagnosis of chronic low back pain, defined as low back pain occurring every day for at least 3 months or on at least half of the days during the previous 6 -months.\n* Willingness to participate in the study.\n\nExclusion Criteria:\n\n* Body mass index \\>30 kg\u002Fm².\n* Inability to understand study instructions.\n* Neurological conditions affecting the central nervous system (e.g., stroke or spinal cord injury).\n* Pregnancy.\n* Currently receiving alternative therapies.\n* Previous participation in a pain education program.\n* History of trauma or orthopedic surgery within the previous 12 months.","ALL","18 Years","60 Years",{"count":95,"type":96},82,"ESTIMATED","INTERVENTIONAL",[99],"NA","Chronic low back pain can affect daily activities and may be influenced by how people understand pain, their fear of movement, and their responses to stressful or uncertain physical activities. This clinical trial will evaluate whether a 6-week program combining pain science education with graded exposure to movement is more effective than usual physical therapy for adults with chronic low back pain.\n\nParticipants will be randomly assigned to one of two groups: pain science education combined with graded exposure to movement, or usual physical therapy. The study will assess changes in pain, disability, fear of movement, and pain-related thoughts. It will also examine physiological responses to stress and muscle activity while participants perform a lifting task.\n\nThe study aims to determine whether combining education about pain with gradual exposure to feared movements can improve clinical outcomes, physiological responses to stress, and motor performance in people with chronic low back pain.",[102],"Chronic Low-back Pain (cLBP)","NOT_YET_RECRUITING","2026-09-17",{"date":106,"type":107},"2026-09-23","ACTUAL",{"date":109,"type":96},"2026-11-02",{"date":111,"type":96},"2028-03-31",{"name":5,"class":6}]