Ignite Creation Date:
2025-12-24 @ 12:34 PM
Ignite Modification Date:
2026-02-20 @ 10:44 PM
Study NCT ID:
NCT06021561
Status:
WITHDRAWN
Last Update Posted:
2024-04-09
First Post:
2023-08-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Orofacial Pain in Multiple Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}, {'id': 'D005157', 'term': 'Facial Pain'}], 'ancestors': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'the principal investigator changed her mind and gave up from the study', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2023-09-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-06', 'studyFirstSubmitDate': '2023-08-18', 'studyFirstSubmitQcDate': '2023-08-29', 'lastUpdatePostDateStruct': {'date': '2024-04-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The frequency of orofacial pain in patients with multiple sclerosis', 'timeFrame': '3 months', 'description': 'To investigate that, hospital records will be reviewed. Additionally, all of the patients will be approached with the questionnaire investigating the frequency of orofacial pain (expressed in number and proportion of all patients)'}, {'measure': 'The location of orofacial pain in patients with multiple sclerosis', 'timeFrame': '3 months', 'description': 'To investigate that, hospital records will be reviewed. Additionally, all of the patients will be approached with the questionnaire investigating the loacation of orofacial pain'}, {'measure': 'The duration of orofacial pain in patients with multiple sclerosis', 'timeFrame': '3 months', 'description': 'To investigate that, hospital records will be reviewed. Additionally, all of the patients will be approached with the questionnaire investigating the duration of orofacial pain (in months)'}], 'secondaryOutcomes': [{'measure': "MS therapy's influence to pain", 'timeFrame': '3 months', 'description': 'To investigate connection between orofacial pain and multiple sclerosis therapy'}, {'measure': 'MS orofacial pain and the duration of the disease', 'timeFrame': '3 months', 'description': 'To investigate the connection between orofacial pain and the duration of the disease'}, {'measure': "Pain and patients' characteristics", 'timeFrame': '3 months', 'description': 'To investigate the pain characteristics in relation to age, sex, form of the disease'}, {'measure': 'Other chronic diseases and orofacial pain', 'timeFrame': '3 months', 'description': 'To investigate the influence of other chronic diseases on orofacial pain in patients with multiple sclerosis'}, {'measure': 'Pain and daily functioning', 'timeFrame': '3 months', 'description': 'To investigate the impact of pain on the daily functioning of patients with multiple sclerosis'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['facial pain', 'craniofacial pain', 'multiple sclerosis'], 'conditions': ['Multiple Sclerosis']}, 'referencesModule': {'references': [{'pmid': '19138330', 'type': 'BACKGROUND', 'citation': 'Putzki N, Pfriem A, Limmroth V, Yaldizli O, Tettenborn B, Diener HC, Katsarava Z. Prevalence of migraine, tension-type headache and trigeminal neuralgia in multiple sclerosis. Eur J Neurol. 2009 Feb;16(2):262-7. doi: 10.1111/j.1468-1331.2008.02406.x. Epub 2008 Dec 9.'}, {'pmid': '28850402', 'type': 'BACKGROUND', 'citation': 'Young J, Amatya B, Galea MP, Khan F. Chronic pain in multiple sclerosis: A 10-year longitudinal study. Scand J Pain. 2017 Jul;16:198-203. doi: 10.1016/j.sjpain.2017.04.070. Epub 2017 May 24.'}, {'pmid': '19345781', 'type': 'BACKGROUND', 'citation': 'Hirsh AT, Turner AP, Ehde DM, Haselkorn JK. Prevalence and impact of pain in multiple sclerosis: physical and psychologic contributors. Arch Phys Med Rehabil. 2009 Apr;90(4):646-51. doi: 10.1016/j.apmr.2008.10.019.'}, {'pmid': '30782116', 'type': 'BACKGROUND', 'citation': 'Di Stefano G, Maarbjerg S, Truini A. Trigeminal neuralgia secondary to multiple sclerosis: from the clinical picture to the treatment options. J Headache Pain. 2019 Feb 19;20(1):20. doi: 10.1186/s10194-019-0969-0.'}, {'pmid': '30623861', 'type': 'BACKGROUND', 'citation': 'Kahraman T, Ozdogar AT, Ertekin O, Ozakbas S. Frequency, type, distribution of pain and related factors in persons with multiple sclerosis. Mult Scler Relat Disord. 2019 Feb;28:221-225. doi: 10.1016/j.msard.2019.01.002. Epub 2019 Jan 3.'}, {'pmid': '27864731', 'type': 'BACKGROUND', 'citation': 'Mazhari A. Multiple Sclerosis-Related Pain Syndromes: An Imaging Update. Curr Pain Headache Rep. 2016 Dec;20(12):63. doi: 10.1007/s11916-016-0594-4.'}, {'pmid': '29070964', 'type': 'BACKGROUND', 'citation': 'Fallata A, Salter A, Tyry T, Cutter GR, Marrie RA. Trigeminal Neuralgia Commonly Precedes the Diagnosis of Multiple Sclerosis. Int J MS Care. 2017 Sep-Oct;19(5):240-246. doi: 10.7224/1537-2073.2016-065.'}, {'pmid': '22742955', 'type': 'BACKGROUND', 'citation': 'Danesh-Sani SA, Rahimdoost A, Soltani M, Ghiyasi M, Haghdoost N, Sabzali-Zanjankhah S. Clinical assessment of orofacial manifestations in 500 patients with multiple sclerosis. J Oral Maxillofac Surg. 2013 Feb;71(2):290-4. doi: 10.1016/j.joms.2012.05.008. Epub 2012 Jun 27.'}, {'pmid': '20625916', 'type': 'BACKGROUND', 'citation': 'Kister I, Caminero AB, Monteith TS, Soliman A, Bacon TE, Bacon JH, Kalina JT, Inglese M, Herbert J, Lipton RB. Migraine is comorbid with multiple sclerosis and associated with a more symptomatic MS course. J Headache Pain. 2010 Oct;11(5):417-25. doi: 10.1007/s10194-010-0237-9. Epub 2010 Jul 13.'}, {'pmid': '26698259', 'type': 'BACKGROUND', 'citation': 'Zhang GQ, Meng Y. Oral and craniofacial manifestations of multiple sclerosis: implications for the oral health care provider. Eur Rev Med Pharmacol Sci. 2015 Dec;19(23):4610-20.'}, {'pmid': '23318126', 'type': 'BACKGROUND', 'citation': 'Foley PL, Vesterinen HM, Laird BJ, Sena ES, Colvin LA, Chandran S, MacLeod MR, Fallon MT. Prevalence and natural history of pain in adults with multiple sclerosis: systematic review and meta-analysis. Pain. 2013 May;154(5):632-642. doi: 10.1016/j.pain.2012.12.002. Epub 2012 Dec 14.'}, {'pmid': '15365151', 'type': 'BACKGROUND', 'citation': "Solaro C, Brichetto G, Amato MP, Cocco E, Colombo B, D'Aleo G, Gasperini C, Ghezzi A, Martinelli V, Milanese C, Patti F, Trojano M, Verdun E, Mancardi GL; PaIMS Study Group. The prevalence of pain in multiple sclerosis: a multicenter cross-sectional study. Neurology. 2004 Sep 14;63(5):919-21. doi: 10.1212/01.wnl.0000137047.85868.d6."}, {'pmid': '16949751', 'type': 'BACKGROUND', 'citation': 'Hadjimichael O, Kerns RD, Rizzo MA, Cutter G, Vollmer T. Persistent pain and uncomfortable sensations in persons with multiple sclerosis. Pain. 2007 Jan;127(1-2):35-41. doi: 10.1016/j.pain.2006.07.015. Epub 2006 Sep 1.'}, {'pmid': '31317971', 'type': 'BACKGROUND', 'citation': 'Labuz-Roszak B, Niewiadomska E, Kubicka-Baczyk K, Skrzypek M, Tyrpien-Golder K, Majewska A, Matejczyk A, Dobrakowski P, Pierzchala K. Prevalence of pain in patients with multiple sclerosis and its association with anxiety, depressive symptoms and quality of life. Psychiatr Pol. 2019 Apr 30;53(2):475-486. doi: 10.12740/PP/94469. Epub 2019 Apr 30. English, Polish.'}]}, 'descriptionModule': {'briefSummary': 'Although the orofacial pain is not typical symptom of multiple sclerosis, more than 50% of the patients experience some kind of pain. Acute pain usually in form of trigeminal neuralgia, that occurred in 2-3% of patients with multiple sclerosis. Chronic pain occurred in 40-50% of patients and most common forms are headache. Aim of this study is to investigate prevalence and evaluate the form of orofacial pain in patients with multiple sclerosis treated in General hospital Varaždin in period from 01.01. 2017. to 31.12.2022. Results of this investigation will determine better understanding orofacial pain , treatment and impact on everyday life.', 'detailedDescription': "Multiple sclerosis is a chronic autoimmune disease with an unknown mechanism of origin. Although pain is not a typical symptom of multiple sclerosis, it occurs in more than 50% of patients and has significant impact on the quality of life of patients. Pain syndromes that patients with multiple sclerosis initially have characteristics of somatic and nociceptive pain, and later neuropathic, including trigeminal neuralgia, headaches, Lhermitte's syndrome.\n\nPain is also often associated with anxiety and depression, which occurs in almost one third of patients.\n\nPain therapy in these patients is a challenge for many doctors involved in the treatment. Many patients do not have adequate pain therapy due to the disproportion between the fear of interaction with other drugs and side effects, and on the other hand the treatment of basic diseases with the aim of controlling the immune response."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Multiple sclerosis patients aged 18-65 years registered in Varazdin General Hospital from 1 January 2017 to 31 December 2022', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* multiple scerosis\n* age 18-85 years\n\nExclusion Criteria:\n\n* records with missing data'}, 'identificationModule': {'nctId': 'NCT06021561', 'briefTitle': 'Orofacial Pain in Multiple Sclerosis', 'organization': {'class': 'OTHER', 'fullName': 'Varazdin General Hospital'}, 'officialTitle': 'Orofacial Pain in Multiple Sclerosis', 'orgStudyIdInfo': {'id': '21062023'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Multiple sclerosis group', 'description': 'Multiple sclerosis patients registered in Varazdin General Hospital from 1 January 2017 - 31 December 2022', 'interventionNames': ['Diagnostic Test: Diagnosis of pain']}], 'interventions': [{'name': 'Diagnosis of pain', 'type': 'DIAGNOSTIC_TEST', 'description': 'Pain will be investigated - type, origin, level', 'armGroupLabels': ['Multiple sclerosis group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '42000', 'city': 'Varaždin', 'country': 'Croatia', 'facility': 'Varazdin General Hospital', 'geoPoint': {'lat': 46.30444, 'lon': 16.33778}}], 'overallOfficials': [{'name': 'Monika Kocman Panic, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Varazdin General Hospital, Varazdin, Croatia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Varazdin General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}