Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2025-12-31 @ 6:29 AM
Study NCT ID:
NCT07123233
Status:
RECRUITING
Last Update Posted:
2025-11-18
First Post:
2025-08-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Innovative Cognitive-Behavioral Treatment For Chronic Orofacial Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic Pain'}, {'id': 'D000098653', 'term': 'Nociplastic Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-09-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2028-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-14', 'studyFirstSubmitDate': '2025-08-07', 'studyFirstSubmitQcDate': '2025-08-07', 'lastUpdatePostDateStruct': {'date': '2025-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Average pain intensity over the past week.', 'timeFrame': '12 months', 'description': 'Average pain intensity over the past week, measured with the BPI-SF.'}], 'secondaryOutcomes': [{'measure': 'Quality of life (EUROHIS-8)', 'timeFrame': '12 months', 'description': "It includes 8 items scored from 1 to 5 using a 5-point Likert scale investigating the satisfaction on different life domains (i.e., socio-economic conditions, health conditions, satisfaction with oneself and with one's relationships, etc.). A high total score corresponds to a high perception of quality of life."}, {'measure': 'Depressive and anxiety symptoms (BDI-II, BAI)', 'timeFrame': '12 months', 'description': 'BDI-II - It consists of 21 items, each scored on a 4-point Likert scale (ranging from 0 to 3). A score above 13 points indicates the presence of clinical depression symptoms. BAI - It consists of 21 items, each scored on a 4-point Likert scale (ranging from 0 to 3). A score above 7 points indicates the presence of clinical anxiety symptoms.'}, {'measure': 'Catastrophism (PCS)', 'timeFrame': '12 months', 'description': 'it measures feelings of helplessness, magnification, and rumination. It has 13 items, each reflecting different aspects of catastrophic thinking related to pain. Respondents rate each item on a 5-point Likert scale, ranging from 0 (not at all) to 4 (extremely), based on how frequently they experience the thought or feeling described. Higher scores indicate greater levels of pain catastrophizing.'}, {'measure': 'Psychopathology (MCMI-III)', 'timeFrame': '12 months', 'description': 'It is a validated self-administered inventory with 175 true-false questions, assessing 14 personality disorder scales, divided into fourteen clinical patterns of personality based on Axis II disorders of DSM-IV, and ten clinical syndrome scales based on Axis I disorders of DSM-IV.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cognitive-behavioral therapy', 'Pain-Reprocessing Therapy', 'Chronic Primary Orofacial pain', 'chronic pain', 'chronic primary pain', 'nociplastic pain'], 'conditions': ['Chronic Primary Orofacial Pain (CPOP)', 'Persistent Idiopathic Facial Pain (PIFP)']}, 'referencesModule': {'references': [{'pmid': '16141303', 'type': 'BACKGROUND', 'citation': 'Schmidt S, Muhlan H, Power M. The EUROHIS-QOL 8-item index: psychometric results of a cross-cultural field study. Eur J Public Health. 2006 Aug;16(4):420-8. doi: 10.1093/eurpub/cki155. Epub 2005 Sep 1.'}, {'pmid': '21912846', 'type': 'BACKGROUND', 'citation': 'Monticone M, Baiardi P, Ferrari S, Foti C, Mugnai R, Pillastrini P, Rocca B, Vanti C. Development of the Italian version of the Pain Catastrophising Scale (PCS-I): cross-cultural adaptation, factor analysis, reliability, validity and sensitivity to change. Qual Life Res. 2012 Aug;21(6):1045-50. doi: 10.1007/s11136-011-0007-4. Epub 2011 Sep 13.'}, {'pmid': '30586072', 'type': 'BACKGROUND', 'citation': 'Benoliel R, Svensson P, Evers S, Wang SJ, Barke A, Korwisi B, Rief W, Treede RD; IASP Taskforce for the Classification of Chronic Pain. The IASP classification of chronic pain for ICD-11: chronic secondary headache or orofacial pain. Pain. 2019 Jan;160(1):60-68. doi: 10.1097/j.pain.0000000000001435.'}, {'pmid': '8482298', 'type': 'BACKGROUND', 'citation': 'Robson WL, Leung AK, Kabani AM, Fick GH. Pseudohyperkalaemia in Kawasaki disease. Eur J Pediatr. 1993 Apr;152(4):379-80. doi: 10.1007/BF01956763. No abstract available.'}, {'pmid': '28425324', 'type': 'BACKGROUND', 'citation': 'Benoliel R, Gaul C. Persistent idiopathic facial pain. Cephalalgia. 2017 Jun;37(7):680-691. doi: 10.1177/0333102417706349. Epub 2017 Apr 20.'}, {'pmid': '30586068', 'type': 'BACKGROUND', 'citation': 'Nicholas M, Vlaeyen JWS, Rief W, Barke A, Aziz Q, Benoliel R, Cohen M, Evers S, Giamberardino MA, Goebel A, Korwisi B, Perrot S, Svensson P, Wang SJ, Treede RD; IASP Taskforce for the Classification of Chronic Pain. The IASP classification of chronic pain for ICD-11: chronic primary pain. Pain. 2019 Jan;160(1):28-37. doi: 10.1097/j.pain.0000000000001390.'}]}, 'descriptionModule': {'briefSummary': '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/psychotherapy 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/psychotherapy 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '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.'}, 'identificationModule': {'nctId': 'NCT07123233', 'acronym': 'FACE-PRT', 'briefTitle': 'An Innovative Cognitive-Behavioral Treatment For Chronic Orofacial Pain', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta'}, 'officialTitle': 'Reprocessing The Fear Of Pain - A Cognitive-Behavioral Protocol For Chronic Primary Orofacial Pain Diseases.', 'orgStudyIdInfo': {'id': 'FACE-PRT'}, 'secondaryIdInfos': [{'id': 'GR2024', 'type': 'OTHER_GRANT', 'domain': 'FONDAZIONE CARIPLO'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PRT-TAU', 'description': 'Patients will attend 8 sessions of PRT treatments while undergoing their usual pharmacological treatment', 'interventionNames': ['Behavioral: Pain Reprocessing Therapy']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'TAU', 'description': 'Patients will undergo the usual pharmacological treatment.', 'interventionNames': ['Behavioral: Usual Therapy']}], 'interventions': [{'name': 'Pain Reprocessing Therapy', 'type': 'BEHAVIORAL', 'description': 'One cohort of 30 patients (PRT+TAU group) will receive eight sessions of Pain Reprocessing Therapy (PRT) in addition to Treatment-as-Usual (TAU). PRT is a cognitive-behavioral-inspired approach aimed at helping patients reinterpret chronic pain as brain-generated rather than structurally caused.\n\nA second cohort of 30 patients (TAU group) will undergo the same assessment phases but will receive only Treatment-as-Usual without PRT.\n\nUse this module to add a description of each group or cohort in the study and to list any interventions of interest.', 'armGroupLabels': ['PRT-TAU']}, {'name': 'Usual Therapy', 'type': 'BEHAVIORAL', 'description': 'Patients undergo yhe usual pharmacological tretment as prescrived by neurologist', 'armGroupLabels': ['TAU']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20133', 'city': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Licia Grazzi, MD', 'role': 'CONTACT', 'email': 'licia.grazzi@istituto-besta.it', 'phone': '+ 39 02.2394'}, {'name': 'Alessandra Telesca, PHD', 'role': 'CONTACT', 'email': 'alessandra.telesca@istituto-besta.it', 'phone': '0039.02.2394'}], 'facility': 'Fondazione IRCCS Istituto Neurologico Carlo Besta', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}], 'centralContacts': [{'name': 'Licia Grazzi, MD', 'role': 'CONTACT', 'email': 'licia.grazzi@istituto-besta.it', 'phone': '+ 39 02.2394'}, {'name': 'Alessandra Telesca, phd', 'role': 'CONTACT', 'email': 'alessandra.telesca@istituto-besta.it'}], 'overallOfficials': [{'name': 'Licia Grazzi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fondazione IRCCS Istituto Neurologico Carlo Besta'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}