[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100639545":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":26,"responsibleParty":37,"collaborators":39,"id":43,"slug":44,"hasResults":45,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":26,"eligibilityCriteria":49,"healthyVolunteers":45,"sex":50,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":26,"studyType":56,"phases":57,"briefSummary":59,"conditions":60,"keywords":64,"overallStatus":74,"whyStopped":26,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":26},{"fullName":5,"class":6},"Centro Universitário Augusto Motta","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Cognitive Functional Therapy (CFT)","EXPERIMENTAL","Participants allocated to this group will receive Cognitive Functional Therapy (CFT), a physiotherapy-led intervention targeting pain-related behaviors, beliefs, and functional limitations. The program includes individualized sessions focusing on making sense of pain, exposure with control, and lifestyle changes. Sessions will be delivered weekly over a period of up to 12 weeks. The physiotherapist--researcher has completed more than 80 hours of training, including in--person and online courses, supervisions and interactive case discussions with feedback by physical therapists with more than 10 years of clinical experience using CFT in Brazil.",[13],"Behavioral: CFT",{"label":15,"type":16,"description":17,"interventionNames":18},"Sham Detuned Photobiomodulation","SHAM_COMPARATOR","Participants allocated to this group will receive sham photobiomodulation combined with neutral talking. The intervention is designed to control for non-specific effects such as therapist attention and interaction, without delivering an active intervention. Sessions will be conducted weekly over the study period.",[19],"Device: Sham Detuned Photobiomodulation",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BEHAVIORAL","CFT","Participants will receive up to eight sessions of Cognitive Functional Therapy (CFT), each lasting 50 minutes, delivered once per week over a maximum of 12 weeks; the first session will last 60 minutes. Weekly reminders will be provided to enhance adherence.\n\nAll participants will receive an educational booklet addressing chronic pain, maladaptive beliefs, and unhelpful pain-related behaviors. The intervention includes individualized strategies aimed at improving pain understanding, reducing protective behaviors, promoting functional movement, and supporting lifestyle changes. The program also incorporates strategies for autonomous management of symptom exacerbations.\n\nThe fidelity of the CFT intervention will be monitored through recorded sessions throughout the clinical trial. Recordings will be made for every seven participants allocated to the CFT group. Three researchers with expertise in the CFT will watch the recorded videos and provide feedback to the treating physiotherapist.",[9],null,{"type":28,"name":15,"description":29,"armGroupLabels":30,"otherNames":26},"DEVICE","A detuned photobiomodulation device (infrared DMC 904 nm, non-visible beam) will be used, delivering no therapeutic dose (0 J). Applications will be performed at standardized points in the lumbar region, including central points over the spinous processes and bilateral paravertebral regions, without active energy delivery.\n\nEach session will last 27 minutes, totaling eight sessions per participant. Additionally, participants will receive at least 15 minutes of neutral talking, in which maladaptive beliefs will not be challenged. The therapist will maintain an empathetic and engaging posture while encouraging discussion of neutral topics (e.g., hobbies, sports, current events), without providing advice or problem-solving. Pain-related or emotional discussions will be gently redirected. Weekly reminders will be provided to enhance adherence. All participants will receive an educational booklet addressing chronic pain, maladaptive beliefs, and unhelpful pain-related behaviors.",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Thátira Camilo, PhD student","CONTACT","+5528999696872","thatirabalestrero@gmail.com",{"type":38,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[40],{"name":41,"class":42},"Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.","OTHER_GOV","100639545","efficacy-of-cognitive-functional-therapy-in-individuals-with-chronic-low-back-pain-after-spinal-surgery-100639545",false,"NCT07576062","Efficacy of Cognitive Functional Therapy in Individuals With Chronic Low Back Pain After Spinal Surgery","Efficacy of Cognitive Functional Therapy in Individuals With Chronic Low Back Pain After Spinal Surgery: A Randomized, Sham-Controlled Trial","Inclusion Criteria:\n\n* Age 18-75 years\n* Chronic low back pain ≥12 weeks\n* History of lumbar surgery ≥3 months\n* Pain intensity ≥3 (NPRS)\n* ODI ≥14%\n\nExclusion Criteria:\n\n* Serious spinal pathology\n* Neurological disorders\n* Radiculopathy\n* Pregnancy\n* Unstable cardiac conditions","ALL","18 Years","75 Years",{"count":54,"type":55},90,"ESTIMATED","INTERVENTIONAL",[58],"NA","Chronic low back pain after spinal surgery is a complex and disabling condition influenced by biopsychosocial factors. Cognitive Functional Therapy (CFT) is a promising intervention targeting these multidimensional aspects. This randomized, sham-controlled trial aims to compare the efficacy of CFT versus a sham intervention (detuned photobiomodulation) in participants with chronic low back pain after spinal surgery.",[61,62,63],"Chronic Low Back Pain","After Lumbar Spine Surgery","Failed Back Surgery Syndrome (FBSS)",[65,66,67,68,69,70,71,72,73],"Cognitive Functional Therapy","Spinal Surgery","Low-intensity light therapy","Placebo","Pain management","back pain","chronic pain","low back pain","Sham","NOT_YET_RECRUITING","2026-05-03",{"date":77,"type":78},"2026-05-08","ACTUAL",{"date":80,"type":55},"2026-05",{"date":82,"type":55},"2027-11",{"name":5,"class":6}]