[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100652387":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":26,"centralContacts":31,"locations":40,"responsibleParty":58,"collaborators":36,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":36,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":36,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":36,"overallStatus":43,"whyStopped":36,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Beni-Suef University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Micronized Palmitoylethanolamide Group","ACTIVE_COMPARATOR","About 53 patients suffering from low back pain will receive Micronized Palmitoylethanolamide 600 mg tablets orally twice daily with the traditional treatment (NSAIDs, muscle relaxant and gabapentin): and physiotherapy for 6 months.",[13],"Drug: Palmitoylethanolamide",{"label":15,"type":10,"description":16,"interventionNames":17},"Control group","About 53 patients suffering from low back pain will receive Traditional treatment (NSAIDs, Muscle relaxant, gabapentin) and physiotherapy.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","Palmitoylethanolamide","to evaluate the effect of PEA and traditional treatment versus traditional treatment alone for the patiens with chronic low back pain on pain intensity, disability and patient satisfaction at baseline, 3 months, and 6 months.",[15,9],[25],"traditional treatment",[27],{"name":28,"affiliation":29,"role":30},"Hatem Elmoutaz Mahmoud, M.D","Professor of Anaesthesiology,Surgical intensive care and pain management,Faculty of medicine","STUDY_CHAIR",[32,38],{"name":33,"role":34,"phone":35,"phoneExt":36,"email":37},"Hager Essam Nasrallah","CONTACT","+201149106597",null,"hagernasrallah778@gmail.com",{"name":39,"role":34,"phone":36,"phoneExt":36,"email":36},"Wael Fathy Hassan, M.D",[41],{"facility":42,"status":43,"city":44,"state":36,"zip":36,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Beni Suef University Hospital","RECRUITING","Banī Suwayf","Egypt","EG",{"type":48,"coordinates":49},"Point",[50,51],31.09785,29.07441,{"lat":51,"lon":50},[54,56],{"name":55,"role":34,"phone":36,"phoneExt":36,"email":36},"Mohamed Abdelbadie Ali, Lecturer",{"name":57,"role":34,"phone":36,"phoneExt":36,"email":36},"Marwa Abd elsalam khames Elgaly, Lecturer",{"type":59,"investigatorFullName":33,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":36,"oldOrganization":36},"PRINCIPAL_INVESTIGATOR","Specialist at Anaesthesiology, Surgical intensive care unit and pain management","100652387","palmitoylethanolamide-modulates-central-sensitisation-and-neuroinflammation-in-chronic-low-back-pain-100652387",false,"NCT07772141","Palmitoylethanolamide Modulates Central Sensitisation and Neuroinflammation in Chronic Low Back Pain","Palmitoylethanolamide Modulates Central Sensitisation and Neuroinflammation in Chronic Low Back Pain: A Randomized Controlled Trial With Neurophysiological and Biomarker Correlates","Inclusion Criteria:\n\n* With chronic pain (more than 3 months)\n* Patients with NRS (4 -7)\n* MRI evidence of disc protrusion or prolapse limited to one or two lumbar discs, without extensive multi-level pathology\n* Diagnosed clinically with low back pain due to disc disease.\n* ASA I and ASA II\n\nExclusion Criteria:\n\n* Neurological disorders\n* psychiatric illness\n* pregnancy\n* prior spinal surgery\n* concurrent use of immunomodulatory drugs\n* contraindications to TMS.\n* Allergy to the drug","ALL","18 Years","65 Years",{"count":72,"type":73},106,"ESTIMATED","INTERVENTIONAL",[76],"NA","Low back pain (LBP) is a public and occupational health problem that is a major professional, economic and social burden. Up to 84% of the general population will experience an episode of LBP during its life time, and recurrence rates are high. Acute LBP is the second reason for consultations in general medicine, and chronic LBP is the eighth. One in five LBP episodes result in sick leave. LBP represents 30% of sick leaves that are longer than 6 months, and 20% of work accidents. LBP has become the leading cause of exclusion from work before the age of 45, and the third cause of work disabilities in France.\n\nIn 2020 globally, LBP affected approximately 619 million people, making it the leading cause of disability worldwide. This number is projected to rise to 843 million by 2050, driven by population growth and aging.",[79],"Chronic Low-back Pain","2026-08-17",{"date":82,"type":83},"2026-08-19","ACTUAL",{"date":85,"type":83},"2026-01-01",{"date":87,"type":73},"2027-06-10",{"name":5,"class":6},1]