[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"persistent-idiopathic-facial-pain-pifp\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:persistent-idiopathic-facial-pain-pifp":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100653717","deciphering-persistent-orofacial-pain---pifp-100653717",false,"NCT07791004","Deciphering Persistent Orofacial Pain - PIFP","Deciphering Persistent Orofacial Pain - Persistent Idiopathic Facial Pain","Inclusion Criteria:\n\n* Healthy controls: written informed consent.\n* PIFP cohort: written informed consent, and a diagnosis of PIFP according to the ICHD-3 and ICOP diagnostic criteria.\n\nExclusion Criteria:\n\n* Contraindication to MR scanning\n* Anxiety disorders, including claustrophobia\n* Other somatic diseases, including other pain disorders\n* Other primary headache disorders and medication-overuse headache\n* Skin lesion , infection, or scarring at the stimulation sites preventing safe electrode placement\n* Healthy volunteers: any history of persistent pain or primary headache, including in first-degree relatives\n* History of psychiatric disease and\u002For addiction\n* Pregnancy or lactation\n* Any regular medication; in PIFP patients, occasional acute analgesic use (NSAID, fewer than 8 days per month) is permitted\n* Use of acute analgesic within 24 hours before the experiment",true,"ALL","18 Years","65 Years",{"count":21,"type":22},60,"ESTIMATED","OBSERVATIONAL","Persistent non-dental orofacial pain is common yet poorly characterised, and its pathophysiology remains largely unknown. Two clinically similar entities are distinguished: post-traumatic trigeminal neuropathic pain (PTNP), in which peripheral nerve damage is demonstrable, and persistent idiopathic facial pain (PIFP), in which peripheral findings are typically absent - pointing to an altered central processing of trigeminal nociceptive input. This monocentric study characterises the peripheral and central mechanisms of PIFP by comparing PIFP patients with age- and sex-matched healthy controls using a combination of non-invasive peripheral and central approaches.\n\nThe study comprises two work packages. The peripheral work package uses quantitative sensory testing (standardised DFNS protocol) to test the hypothesis that PIFP patients retain an intact peripheral nervous system. The central work package uses functional MRI with standardised trigemino-nociceptive stimulation to characterise brainstem network dynamics, testing the hypothesis that PIFP patients exhibit a central trigeminal processing disturbance at the brainstem level. In PIFP patients, the functional MRI is repeated before and after a local-anaesthetic nerve block in the pain area, additionally distinguishing patients whose pain is completely abolished by the block from those with persistent pain despite it. The overarching aim is to characterise the pathophysiological basis of PIFP and thereby advance the mechanistic understanding of persistent orofacial pain.",[26],"Persistent Idiopathic Facial Pain (PIFP)",[28,29,30,31,32],"PIFP","fMRI","atypical facial pain","nerve block","local anesthesia","NOT_YET_RECRUITING","2026-08-25",{"date":36,"type":37},"2026-08-27","ACTUAL",{"date":39,"type":22},"2026-09-01",{"date":41,"type":22},"2029-10-31",{"name":43,"class":44},"Universitätsklinikum Hamburg-Eppendorf","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":56,"phases":57,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":45},"100602417","an-innovative-cognitive-behavioral-treatment-for-chronic-orofacial-pain-100602417","NCT07123233","An Innovative Cognitive-Behavioral Treatment For Chronic Orofacial Pain","Reprocessing The Fear Of Pain - A Cognitive-Behavioral Protocol For Chronic Primary Orofacial Pain Diseases.","FACE-PRT","Inclusion Criteria:\n\n* Diagnosis of Chronic Primary Orofacial Pain (CPOP) according to ICD-11 criteria.\n* Patient-reported pain rating of 4 or higher out of 10 on the Brief Pain Inventory (BPI) question assessing average pain over the past week, consistent with inclusion criteria from previous chronic pain studies.\n* Written informed consent.\n* Age 18 years or older.\n\nExclusion Criteria:\n\n* Age over 70 years.\n* Current use of immunosuppressive medications (e.g., steroids).\n* History of cancer (breast, thyroid, prostate, blood cancers, etc.).\n* History of stroke, neurosurgical interventions, or brain tumors.\n* History of specific inflammatory diseases (lupus, scleroderma, rheumatoid arthritis, polymyalgia rheumatica).\n* History of psychiatric disorders such as schizophrenia, personality disorders, dissociative identity disorder, or other severe psychoses.\n* Unexpected or unintentional weight loss of 10 kg or more in the year prior to recruitment.\n* Difficulty participating due to logistical problems.\n* Contraindications to undergoing functional magnetic resonance imaging (fMRI).\n* Psychotherapy treatment of any kind within 15 months prior to the assessment date.","70 Years",{"count":21,"type":22},"INTERVENTIONAL",[58],"NA","Use these resources to provide understandable information about this study to patients, families, and health care providers:\n\nThe present randomized clinical trial (RCT), conducted at the IRCCS Carlo Besta Neurological Institute, aims to evaluate the effectiveness of Pain Reprocessing Therapy (PRT), a form of psychological support\u002Fpsychotherapy based on cognitive-behavioral therapy, which has already proven effective in the treatment of other types of primary chronic pain.\n\nChronic Primary Orofacial Pain (CPOP) is a rare and complex form of chronic pain that predominantly affects adult women and occurs without evident lesions, yet has a significant emotional and functional impact. It was recently classified among chronic primary pain conditions in the ICD-11 and is considered a form of nociplastic pain, associated with alterations in brain connectivity. At present, pharmacological treatments have shown limited effectiveness.\n\nThis randomized clinical trial (RCT), conducted at the IRCCS Carlo Besta Neurological Institute, aims to evaluate the effectiveness of Pain Reprocessing Therapy (PRT), a form of psychological support\u002Fpsychotherapy based on cognitive-behavioral therapy, which has already proven effective in the treatment of other types of primary chronic pain.\n\nSixty participants, all diagnosed with CPOP according to ICD-11 criteria, will be selected and randomly assigned to two groups: one will receive PRT, the other will receive treatment as usual (TAU).\n\nThe primary outcome of the study is the assessment of pain intensity reduction. Secondary outcomes include a broad range of psychosocial variables: improvement in quality of life, reduction of anxiety-depressive symptoms, catastrophizing, and other psychopathological traits. The effects of the therapy on brain connectivity will also be analyzed using fMRI, and on pain neurophysiology through the Conditioned Pain Modulation (CPM) paradigm. The protocol provides for the evaluation of therapy effectiveness at three follow-ups (3, 6, and 12 months) in order to measure the duration of effects.\n\nFinally, through advanced statistical analysis tools and the support of artificial intelligence, the study also aims to identify specific clinical-neurofunctional profiles that may be useful for differential diagnosis and for tailoring therapeutic interventions.",[61,26],"Chronic Primary Orofacial Pain (CPOP)",[63,64,65,66,67,68],"Cognitive-behavioral therapy","Pain-Reprocessing Therapy","Chronic Primary Orofacial pain","chronic pain","chronic primary pain","nociplastic pain","RECRUITING","2026-02-09",{"date":72,"type":37},"2026-02-11",{"date":74,"type":37},"2025-09-24",{"date":76,"type":22},"2028-05",{"name":78,"class":44},"Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta"]