[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100592925":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":49,"centralContacts":53,"locations":59,"responsibleParty":89,"collaborators":91,"id":97,"slug":98,"hasResults":99,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":45,"eligibilityCriteria":103,"healthyVolunteers":99,"sex":104,"minAge":105,"maxAge":106,"enrollmentInfo":107,"targetDuration":45,"studyType":110,"phases":111,"briefSummary":113,"conditions":114,"keywords":116,"overallStatus":62,"whyStopped":45,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":133},{"fullName":5,"class":6},"Laval University","OTHER",[8,15,21],{"label":9,"type":10,"description":11,"interventionNames":12},"Active rTMS + PiP","EXPERIMENTAL","For weeks 1 and 2, participants will attend 5 brain stimulation sessions. During the first phase, the session will last 30-40 min (10-20 min of installation + 20 minutes of stimulation).\n\nIn the second phase (weeks 3-8), brain stimulation and physiotherapy will be delivered in 2 separate sessions during the same week for 6 weeks. Each brain stimulation session will last 30-40 min and each physiotherapy session will last 30-45 min. Overall, participants will receive 11 sessions of rTMS only and 6 PiP sessions.",[13,14],"Device: Active rTMS","Other: Psychologically-informed physiotherapy (PiP)",{"label":16,"type":17,"description":18,"interventionNames":19},"Sham rTMS + PiP","SHAM_COMPARATOR","For weeks 1 and 2, participants will attend 5 sham brain stimulation sessions. During the first phase, the session will last 30-40 min (10-20 min of installation + 20 minutes of stimulation). In the second phase (weeks 3-8), brain stimulation and physiotherapy session will be delivered in 2 separate sessions during the same week for 6 weeks. Each sham brain stimulation session will last 30-40 min and each physiotherapy will last 30-45 min. Overall, participants will receive 11 sessions of sham rTMS only and 6 PiP sessions.",[20,14],"Device: Sham rTMS",{"label":22,"type":23,"description":24,"interventionNames":25},"Usual physiotherapy","ACTIVE_COMPARATOR","Participants will attend 6 sessions within 8 weeks (1session \u002Fweek for 4 weeks, 1 session every 2 weeks between weeks 5-8). Each physiotherapy will last 30-45 min.",[26],"Other: Usual physiotherapy",[28,35,41,46],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"DEVICE","Active rTMS","A figure-of-8 coil connected to a biphasic Magstim Rapid 2 stimulator (The MagstimCo, Whitland, UK) will be used. Coil orientation and position will be guided throughout the experiment by a neuronavigation system (Brainsight, Rogue research, Montreal, QC, Canada). Stimulation parameters will be obtained by measuring the motor threshold of the first right interosseous muscle, then the rTMS intensity will be set at 110% of this motor threshold. High frequency (HF) rTMS consisting of 60 trains of 5 s at 10 Hz with 15 s intertrain intervals, for a total of 3000 pulses per session, will be used. The coil will be positioned over the left dorsolateral PFC using the BeamF3 methods.",[9],[34],"Repetitive Transcranial Magnetic Stimulation",{"type":29,"name":36,"description":37,"armGroupLabels":38,"otherNames":39},"Sham rTMS","A sham coil will be used (e.g. equipped with a magnetic shield that blocks the magnetic field). The sham stimulation will last the same duration as the active rTMS and will be located over the same area (dorso-lateral prefrontal cortex).",[16],[40],"Sham Repetitive Transcranial Magnetic Stimulation",{"type":6,"name":42,"description":43,"armGroupLabels":44,"otherNames":45},"Psychologically-informed physiotherapy (PiP)","Participants will receive 6 intervention sessions (45 min) over 6 weeks by a physiotherapist. The objective of this intervention is to identify biopsychosocial factors that may impede recovery and to address these factors within the physiotherapist's scope of practice. Physiotherapists will use strategies such as the establishment of common goals and therapeutic alliance, the use of behavior change model, motivational interview, education on pain neurophysiology, gradual exposure to movement and stress management strategies (e.g. breathing techniques). Participants allocated to PiP groups will have access to a website offering support information related to understanding their pain (e.g. pain neuroscience education), myths and false beliefs related to back pain, understanding the impact of psychological factors on their pain, self-management strategies, and healthy lifestyle habits. This site will be freely available to participants during the course of the study.",[9,16],null,{"type":6,"name":22,"description":47,"armGroupLabels":48,"otherNames":45},"Participants will receive 6 intervention sessions (45 min) over 8 weeks by a physiotherapist. This is a pragmatic group that aims to represent real-word clinical practice i.e. interventions commonly used in physiotherapy to manage CLBP. All interventions that a physiotherapist can deliver in the province of Quebec will be allowed (e.g. manual therapy, exercises). No training will be provided to better reflect usual clinical practice in physiotherapy.",[22],[50],{"name":51,"affiliation":5,"role":52},"Hugo Massé-Alarie, PhD","PRINCIPAL_INVESTIGATOR",[54],{"name":51,"role":55,"phone":56,"phoneExt":57,"email":58},"CONTACT","(418) 529 9141","46642","hugo.masse-alarie@fmed.ulaval.ca",[60,83],{"facility":61,"status":62,"city":63,"state":64,"zip":65,"country":66,"countryCode":67,"cosmosGeoPoint":68,"geoPoint":73,"contacts":74},"Centre interdisciplinaire de recherche en réadaptation et intégration sociale (CIRRIS)","RECRUITING","Québec","Quebec","G1M 2S8","Canada","CA",{"type":69,"coordinates":70},"Point",[71,72],-71.21454,46.81228,{"lat":72,"lon":71},[75,79],{"name":76,"role":55,"phone":77,"phoneExt":78,"email":58},"Hugo Massé-Alarie","418-529-9141","6930",{"name":80,"role":55,"phone":77,"phoneExt":81,"email":82},"Jean Tittley","2478","jean.tittley@cirris.ulaval.ca",{"facility":84,"status":85,"city":63,"state":64,"zip":65,"country":66,"countryCode":67,"cosmosGeoPoint":86,"geoPoint":88,"contacts":45},"Cirris (Centre Interdisciplinaire de Recherche en Réadaptation et Intégration Sociale)","NOT_YET_RECRUITING",{"type":69,"coordinates":87},[71,72],{"lat":72,"lon":71},{"type":52,"investigatorFullName":76,"investigatorTitle":90,"investigatorAffiliation":5,"oldNameTitle":45,"oldOrganization":45},"Associate Professor",[92,95],{"name":93,"class":94},"Chronic Pain Centre of Excellence for Canadian Veterans","UNKNOWN",{"name":96,"class":6},"Foundation for Physical Medicine and Rehabilitation","100592925","combining-brain-stimulation-and-physiotherapy-for-the-management-of-chronic-low-back-pain-100592925",false,"NCT06999772","Combining Brain Stimulation and Physiotherapy for the Management of Chronic Low Back Pain","Combining Non-invasive Brain Stimulation and Physiotherapy to Improve the Management of Chronic Low Back Pain in Veterans","Inclusion Criteria:\n\n* Adults between 18 and 65 years old\n* Military Veterans with non-specific chronic low back pain (\\> 3 months, \\> 50% of the days in the last 6 months)\n* High level of psychosocial factors, scoring ≥4 on the Start Back Screening Tool\n* Functional limitations, scoring ≥ 15% on the Oswestry Disability Index (ODI)\n\nExclusion Criteria:\n\n* Non-musculoskeletal conditions causing low back pain (e.g., neoplasia, fracture)\n* Diagnosis of drug or alcohol abuse\n* Change of drug dosage in the last month for the treatment of pain or mental health\n* Presenting with any specific rTMS-related exclusion criteria such as previous seizure\u002Fconvulsion, cochlear implant, and pregnancy","ALL","18 Years","65 Years",{"count":108,"type":109},96,"ESTIMATED","INTERVENTIONAL",[112],"NA","Chronic low back pain (CLBP) is a major health challenge in Canada, leading to substantial disability and socioeconomic burden, particularly among Veterans. In military Veterans, LBP is the most common chronic pain condition. Conventional interventions have limited effectiveness. The refractoriness to interventions suggests that specific CLBP mechanisms may be missed by current treatments, prompting a shift towards psychologically informed approaches which aim to address emotional and cognitive factors alongside biomedical aspects. The integration of these concepts into physiotherapy is called psychologically informed physiotherapy (PiP). Despite promising results of PiP from randomized controlled trials, residual pain and disability often persist in Veterans. Non-invasive brain stimulation, such as repetitive transcranial magnetic stimulation (rTMS), may enhance the effectiveness of PiP by modulating cognition, emotion, and pain. This proposal seeks to determine whether non-invasive brain stimulation can enhance the effects of PiP.",[115],"Chronic Low-back Pain (cLBP)",[117,118,119,120,121,122,123],"Non-invasive brain stimulation","comorbid psychological risk factors","chronic pain","repetitive transcranial magnetic stimulation","physiotherapy","pyschologically-informed","veterans","2026-01-16",{"date":126,"type":127},"2026-01-20","ACTUAL",{"date":129,"type":127},"2025-06-11",{"date":131,"type":109},"2027-06-01",{"name":5,"class":6},2]