[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100590931":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":10,"centralContacts":31,"locations":41,"responsibleParty":66,"collaborators":69,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":82,"sex":83,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":10,"studyType":89,"phases":10,"briefSummary":90,"conditions":91,"keywords":95,"overallStatus":44,"whyStopped":10,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},{"fullName":5,"class":6},"Vrije Universiteit Brussel","OTHER",[8,14,18,22],{"label":9,"type":10,"description":11,"interventionNames":12},"Pain-free with good sleep habits (healthy controls)",null,"Meeting all General inclusion\u002Fexclusion criteria and Pharmacological exceptions criteria, plus the specific inclusion criteria for \"pain-free\" and \"good sleeper\".",[13],"Other: Real-life monitoring, experimental pain testing, brain imaging, blood and stool sampling.",{"label":15,"type":10,"description":16,"interventionNames":17},"Non-specific chronic low back pain with good sleep habits","Meeting all General inclusion\u002Fexclusion criteria and Pharmacological exceptions criteria, plus the specific inclusion criteria for \"chronic low back pain\" and \"good sleeper\".",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Pain-free with chronic insomnia","Meeting General inclusion\u002Fexclusion criteria and Pharmacological exceptions criteria, plus the specific inclusion criteria for \"pain-free\" and \"chronic insomnia\".",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"Non-specific chronic low back pain with comorbid chronic insomnia","Meeting all General inclusion\u002Fexclusion criteria and Pharmacological exceptions criteria, plus the specific inclusion criteria for \"chronic low back pain\" and \"chronic insomnia\".",[13],[27],{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":10},"Real-life monitoring, experimental pain testing, brain imaging, blood and stool sampling.","See detailed study description and outcome measures.",[23,15,19,9],[32,37],{"name":33,"role":34,"phone":35,"phoneExt":10,"email":36},"Iris Coppieters, PT, PhD","CONTACT","+32 497 92 90 32","iris.coppieters@vub.be",{"name":38,"role":34,"phone":39,"phoneExt":10,"email":40},"Elin Johansson, PT, MSc","+46 702 05 54 52","elinmarie.johansson@kuleuven.be",[42],{"facility":43,"status":44,"city":45,"state":10,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"UZ\u002FKU Leuven","RECRUITING","Leuven","3000","Belgium","BE",{"type":50,"coordinates":51},"Point",[52,53],4.70093,50.87959,{"lat":53,"lon":52},[56,58,60,62,64],{"name":33,"role":34,"phone":57,"phoneExt":10,"email":36},"+324 97 92 90 32",{"name":59,"role":34,"phone":39,"phoneExt":10,"email":40},"Elin Johansson, PT, PhD",{"name":33,"role":61,"phone":10,"phoneExt":10,"email":10},"PRINCIPAL_INVESTIGATOR",{"name":63,"role":61,"phone":10,"phoneExt":10,"email":10},"Lukas Van Oudenhove, MD, PhD",{"name":38,"role":65,"phone":10,"phoneExt":10,"email":10},"SUB_INVESTIGATOR",{"type":61,"investigatorFullName":67,"investigatorTitle":68,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Iris Coppieters","Dr. Iris Coppieters (Principal investigator)",[70,72],{"name":71,"class":6},"Research Foundation - Flanders (Fonds Wetenschappelijk Onderzoek)",{"name":73,"class":6},"Universitaire Ziekenhuizen KU Leuven","100590931","studying-the-neurobiological-mechanisms-of-non-specific-chronic-low-back-pain-and-chronic-insomnia-a-four-group-cross-sectional-study-100590931",false,"NCT06973837","Studying the Neurobiological Mechanisms of Non-specific Chronic Low Back Pain and Chronic Insomnia: a Four-group Cross-sectional Study","Unravelling the Neurobiological Mechanisms Underlying the Bidirectional Relationship Between Chronic Sleep Disturbances and Pain Sensitivity in People With Non-specific Chronic Low Back Pain and Chronic Insomnia","SY-NAPS-CS","General inclusion criteria (all groups):\n\n* 18-60 years old.\n* Ability to speak and understand the Dutch Language.\n* Body mass index \\\u003C30.\n* No smoking or nicotine use.\n* Low caffeine use (≤3 cups of coffee\u002Fday, ≤1 energy drink\u002Fday).\n* Low alcohol use (≤9 alcoholic units\u002Fweek).\n* No use of neuro- and\u002For psychopharmacological treatments and\u002For immunosuppressive agents (including NSAIDs) with a suspected influence on neuroinflammation unless terminated within a sufficient time frame before the start of the study, or unless falling under the Pharmacological exceptions criteria (see below).\n* Willing to (try to) adhere to the acute pre-test restrictions, including refraining from analgesics (unless stable use), caffeine, alcohol, and\u002For strenuous physical activity (\\>3 METs) in the 24 hours preceding the main test day.\n\nGeneral exclusion criteria (all groups):\n\n* Shift worker.\n* Use of blood thinners.\n* (History of) Substance dependence\u002Fabuse.\n* Chronic pain conditions (≥3 months) other than chronic low back pain.\n* Severe intrinsic sleep disorders (assessed during a one-night, laboratory-based polysomnography).\n* Restless leg syndrome\n* Central or peripheral neurological disorder\u002Fcondition (e.g., epilepsy, multiple sclerosis, peripheral neuropathy).\n* History of spinal surgery.\n* Major medical (e.g., cardiac disease, cancer) and\u002For psychiatric disorder\u002Fdisease (e.g., major depressive disorder, bipolar disorder).\n* Claustrophobia.\n* Contraindications for magnetic resonance imaging (e.g., metal\u002Fcochlear implants, pacemaker).\n* Pregnancy or being \\\u003C12 months post-natal.\n\nPharmacological exceptions criteria:\n\n\\- Participants with chronic low back pain and\u002For (comorbid) insomnia will be allowed to be on a stable low dose of weak pain and\u002For sleep agents (e.g., Tramadol, Zolpidem) if medically prescribed specifically for their low back pain and\u002For insomnia, and if approved by the national medicine register of Belgium (FAMHP, Federal Agency for Medicine and Health Products). These participants will also be allowed stable and\u002For occasional use of low-to-moderate doses of over-the-counter medications for pain and\u002For sleep that are suspected to have no or minimal impact on neuroinflammation (e.g., paracetamol, melatonin). Habitual use of medications according to the above-stated criteria should be maintained across the entire study period, with the only exception being analgesics taken on an occasional basis. Specifically, because of the extensive battery of pain tests that will be utilized in the study, all analgesics that are only taken occasionally should be refrained from during the 24 hours preceding the main test day (pre-test instructions).\n\nSpecific inclusion criteria for \"pain-free\" groups:\n\n* Currently pain free, defined as having no pain that affects daily living\u002Ffunctioning and\u002For which has led to a consultation with a healthcare practitioner.\n* No episode of low back pain that interfered with daily functioning\u002Fliving and\u002For which led to a consultation with a healthcare practitioner within 12 months from the time of inclusion.\n* No history of chronic low back pain.\n\nSpecific inclusion criteria for \"chronic low back pain\" groups:\n\n* Low back pain reported on most days (≥50%), every week, for more than 3 months.\n* Low back pain-related emotional disress OR functional disability rated as ≥3 out of 10.\n\nSpecific inclusion criteria for \"good sleeper\" groups:\n\n* Stable sleep phase within 10 PM and 10 AM (assessed using the Pittsburgh Sleep Quality Index).\n* Average habitual total sleep time between 7 and 9 hours (assessed using the Pittsburgh Sleep Quality Index).\n* A Pittsburgh Sleep Quality Index ≤5.\n* An Insomnia Severity Index ≤7.\n* An Epworth Sleepiness Scale ≤10.\n* Sleep efficiency ≥85% during a one-night, laboratory-based polysomnography screening.\n* No episode of sleep disturbances that interfered with daily functioning\u002Fliving and\u002For which led to a consultation with a healthcare practitioner within the preceding 12 months from the time of inclusion.\n* No history of chronic insomnia.\n\nSpecific inclusion criteria for \"chronic insomnia\" groups:\n\n* Chronic insomnia according to the ICSD-3-TR criteria (assessed using an ICSD-3-TR-adapted version of the Pittsburgh Sleep Quality Index).\n* An Insomnia Severity Index ≥15.",true,"ALL","18 Years","60 Years",{"count":87,"type":88},80,"ESTIMATED","OBSERVATIONAL","This study is a part of a larger project aiming to evaluate the neurobiological mechanisms underlying the relationship between sleep and pain in people with non-specific chronic low back pain. Specifically, this study aims to evaluate the neurobiological mechanisms underlying the relationship between chronic sleep disturbances and pain sensitivity in people with non-specific chronic low back pain and chronic insomnia.",[92,93,94],"Chronic Low Back Pain (CLBP)","Chronic Insomnia","Neuroinflammation",[96,97,98,99,100,101,102,103,104,105,106,107,108,109,110,111,112,113],"Pain","Chronic pain","Chronic low back pain","Sleep","Insomnia","Chronic insomnia","Magnetic resonance imaging","Functional magnetic resonance imaging","Magnetic resonance spectroscopy","Diffusion weighted imaging","Quantitative sensory testing","Temporal summation","Conditioned pain modulation","Experience sampling method","Ecological momentary assessment","Microbiota","Gut-Brain axis","Short-chain fatty acids","2025-12-06",{"date":116,"type":117},"2025-12-15","ACTUAL",{"date":119,"type":117},"2025-10-03",{"date":121,"type":88},"2026-10",{"name":5,"class":6},1]