[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100529108":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":37,"locations":47,"responsibleParty":118,"collaborators":121,"id":131,"slug":132,"hasResults":133,"nctId":134,"briefTitle":135,"officialTitle":135,"acronym":136,"eligibilityCriteria":137,"healthyVolunteers":133,"sex":138,"minAge":139,"maxAge":140,"enrollmentInfo":141,"targetDuration":26,"studyType":144,"phases":145,"briefSummary":147,"conditions":148,"keywords":150,"overallStatus":67,"whyStopped":26,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":162,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":170},{"fullName":5,"class":6},"Oslo University Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Lumbar Interbody Fusion (LIF)","EXPERIMENTAL","Per center standard, the LIF procedure is done in one or two levels between the second lumbar vertebra and sacrum, as a transforaminal lumbar interbody fusion (TLIF) or anterior lumbar interbody fusion (ALIF). Stabilization with screws is mandatory. TLIF employs bilateral pedicle screws. ALIF uses either pedicle or intra-device screws.\n\nAt least one surgeon must be proficient in both procedure and implants. TLIF requires visual aids (microscope\u002Fmagnifying glasses) for precise disc preparation. In the TLIF procedure, surgeons will maximize bone implantation into the disc space, anteriorly, posteriorly, or both.\n\nIf the disc space is too narrow for an interbody device, autologous bone grafting into the disc space (local, spongious, or both) with posterior pedicle screw fixation is accepted. Optional posterolateral autologous bone grafting is allowed, but no substitutes or osteoinductive proteins (e.g., BMP). Surgical drain is optional.",[13],"Procedure: Lumbar Interbody Fusion",{"label":15,"type":16,"description":17,"interventionNames":18},"Multidisciplinary Rehabilitation","ACTIVE_COMPARATOR","Rehabilitation, guided by a team of experienced specialists in physical medicine and rehabilitation and physiotherapists trained in cognitive therapy, will direct the multidisciplinary treatment. Patients receive 2.5-5 hour sessions 2-4 days weekly over 3-5 weeks. Standardization is maintained through pre-study training for providers, including seminars, podcasts, videos, and lectures.\n\nIndividual screenings start the process, leading to focused discussions on thoughts, feelings, behaviour, and physical symptoms. A plan for the rehabilitation process with clearly defined individual goals will be worked out and revised every week. The three components described within the framework of cognitive functional therapy will be a template for the implementation of the functional and physical rehabilitation, involving pain understanding, exposure with control, and lifestyle changes like physical activity, sleep, diet, stress management, and social engagement.",[19],"Behavioral: Multidisciplinary rehabilitation",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Lumbar Interbody Fusion","Fusion of one or two lumbar levels with either a transforaminal lumbar interbody fusion (TLIF) or an anterior lumbar interbody fusion (ALIF) procedure.",[9],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"BEHAVIORAL","Multidisciplinary rehabilitation","Outpatient multidisciplinary rehabilitation based on the treatment model described by Brox et al and Hellum et al consisting of a cognitive approach and supervised physical and functional training, but the protocol is somewhat compressed in terms of time and additionally updated in line with recent years' research in cognitive functional rehabilitation.",[15],[33],{"name":34,"affiliation":35,"role":36},"Christian Hellum, PhD","Oslo University Hospital, Division of Orthopedic Surgery, OUS Ullevål","PRINCIPAL_INVESTIGATOR",[38,43],{"name":39,"role":40,"phone":41,"phoneExt":26,"email":42},"Sverre Mjønes, MD","CONTACT","+4767960000","svemjo@ahus.no",{"name":44,"role":40,"phone":45,"phoneExt":26,"email":46},"Kjersti Storheim, PhD","+4722117740","kjersti.storheim@ous-research.no",[48,65,83,92,106],{"facility":49,"status":50,"city":51,"state":26,"zip":26,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Vestre Viken Hospital","NOT_YET_RECRUITING","Drammen","Norway","NO",{"type":55,"coordinates":56},"Point",[57,58],10.20449,59.74389,{"lat":58,"lon":57},[61],{"name":62,"role":40,"phone":63,"phoneExt":26,"email":64},"Lars M Hubschle, MD","0047-03525","Lars.Michael.Hubschle@vestreviken.no",{"facility":66,"status":67,"city":68,"state":26,"zip":26,"country":52,"countryCode":53,"cosmosGeoPoint":69,"geoPoint":73,"contacts":74},"Haukeland University Hospital","RECRUITING","Hagavik",{"type":55,"coordinates":70},[71,72],5.40146,60.18076,{"lat":72,"lon":71},[75,78,80],{"name":76,"role":40,"phone":26,"phoneExt":26,"email":77},"Andreas O Seip, MD","andreas.ottersen.seip@helse-bergen.no",{"name":79,"role":40,"phone":26,"phoneExt":26,"email":26},"Ivar M Austevoll, PhD",{"name":81,"role":82,"phone":26,"phoneExt":26,"email":26},"Janne H Harkestad, MSc","SUB_INVESTIGATOR",{"facility":84,"status":67,"city":85,"state":26,"zip":26,"country":52,"countryCode":53,"cosmosGeoPoint":26,"geoPoint":26,"contacts":86},"Akershus University Hospital","Lørenskog",[87,90],{"name":88,"role":40,"phone":26,"phoneExt":26,"email":89},"Sverre M Mjønes, MD","Sverre.Markussen.Mjones@ahus.no",{"name":91,"role":40,"phone":26,"phoneExt":26,"email":26},"Per Henrik Randsborg",{"facility":5,"status":67,"city":93,"state":26,"zip":26,"country":52,"countryCode":53,"cosmosGeoPoint":94,"geoPoint":98,"contacts":99},"Oslo",{"type":55,"coordinates":95},[96,97],10.74609,59.91273,{"lat":97,"lon":96},[100,104],{"name":34,"role":40,"phone":101,"phoneExt":102,"email":103},"22117493","0047","CHRHEL@ous-hf.no",{"name":105,"role":40,"phone":26,"phoneExt":26,"email":26},"Filip Dolatowski, PhD",{"facility":107,"status":67,"city":108,"state":26,"zip":26,"country":52,"countryCode":53,"cosmosGeoPoint":109,"geoPoint":113,"contacts":114},"St. Olavs Hospital","Trondheim",{"type":55,"coordinates":110},[111,112],10.39506,63.43049,{"lat":112,"lon":111},[115],{"name":116,"role":40,"phone":26,"phoneExt":26,"email":117},"Sivert Hammer, MD","Sivert.Hammer@stolav.no",{"type":36,"investigatorFullName":119,"investigatorTitle":120,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Kjersti Storheim","Senior researcher, professor",[122,124,125,127,128],{"name":123,"class":6},"University Hospital, Akershus",{"name":66,"class":6},{"name":126,"class":6},"Vestre Viken Hospital Trust",{"name":107,"class":6},{"name":129,"class":130},"Unicare","UNKNOWN","100529108","the-lumbar-interbody-fusion-vs-multidisciplinary-rehabilitation-lifehab-trial-100529108",false,"NCT06169488","The Lumbar Interbody Fusion vs. Multidisciplinary Rehabilitation (LIFEHAB) Trial","LIFEHAB","Inclusion Criteria:\n\n1. Male and non-pregnant female patients between 20 and 65 years of age with persistent low back pain of at least one year's duration at inclusion\n2. Received non-operative treatment in line with national \\[50\\] and international \\[49\\] guidelines, including at least self-management, exercise, and physical therapy, without satisfactory effect before study enrolment\n3. Back-related disability: ODI 30 - 60 points at baseline\n4. Back pain \\> leg pain\n5. One- or two-level disc degeneration between L2 and sacrum with any of the following:\n\n   * High-intensity zone (HiZ)\n   * Modic changes\n   * Severe disc height reduction exceeding 50% of the cranial disc\n\nExclusion Criteria:\n\n1. Multilevel disc degeneration requiring intervention beyond two levels\n2. Spondylolysis or lytic spondylolisthesis\n3. History of previous spondylodiscitis\n4. Previous lumbar fusion surgery\n5. Scoliosis \\>20 degrees\n6. Signs of a vertebral fracture at the planned level of fusion or its adjacent levels\n7. Active smokers\n8. Unlikely to adhere to treatment or complete follow-up (e.g., ongoing serious psychiatric disease, drug abuse, plans to move outside the catchment areas of the trial centers)\n9. Significant nerve root compression assessed by MRI and clinical examination\n10. BMI \\> 40\n11. Not understanding the Norwegian language.\n12. Generalized myalgia, including history or signs of fibromyalgia and myalgic encephalitis\n13. Contraindications to MRI (e.g., cardiac pacemaker electrodes, metal implants in the eye or brain, claustrophobia).\n14. Active cancer\n15. Disabling chronic neurological disease (e.g., Parkinson's disease, ALS, MS)\n16. Disabling osteoarthritis of the hip or knee (Kellgren \\& Lawrence grade III or higher)\n17. Daily use of morphine equivalents ≥ 60mg or regular use of morphine-containing pain patches\n18. Decline specific treatment arm","ALL","20 Years","65 Years",{"count":142,"type":143},202,"ESTIMATED","INTERVENTIONAL",[146],"NA","The goal of this randomized controlled trial is to compare lumbar interbody fusion surgery with multidisciplinary rehabilitation in participants aged 20-65 years with persisting (≥ one year) low back pain. The main question it aims to answer is:\n\n• Is lumbar fusion surgery superior to multidisciplinary rehabilitation in alleviating persisting low back pain?\n\nParticipants will be randomized to either lumbar interbody fusion surgery or a multidisciplinary rehabilitation program.\n\nIf randomized to lumbar fusion interbody surgery, the participants will:\n\n* undergo radiologic examinations, including X-ray, MRI, and MRI spectroscopy\n* provide blood samples at four intervals including postoperatively\n* complete PROMs at five intervals\n* have their activity monitored through the ActivePAL accelerometer\n* undergo lumbar fusion surgery\n\nIf randomized to multidisciplinary rehabilitation, the participants will:\n\n* undergo radiologic examinations, including X-ray, MRI, and MRI spectroscopy\n* provide blood samples at three intervals\n* complete PROMs at five intervals\n* have their activity monitored through the ActivePAL accelerometer\n* undergo multidisciplinary rehabilitation",[149],"Chronic Low-back Pain",[151,152,153,154,155,156,157,158,159,160,136],"persisting","chronic","low back pain","MRI spectroscopy","multidisciplinary rehabilitation","lumbar fusion surgery","lumbar interbody fusion","TLIF","rehabilitation","ALIF","2026-03-13",{"date":163,"type":164},"2026-03-17","ACTUAL",{"date":166,"type":164},"2024-04-15",{"date":168,"type":143},"2030-12",{"name":5,"class":6},5]