Ignite Creation Date:
2025-12-25 @ 1:16 AM
Ignite Modification Date:
2026-01-04 @ 3:15 PM
Study NCT ID:
NCT03838393
Status:
COMPLETED
Last Update Posted:
2019-02-15
First Post:
2019-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prognosis of Trigeminal Neuralgia When Enrolled in a Multidisciplinary Management Program
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014277', 'term': 'Trigeminal Neuralgia'}], 'ancestors': [{'id': 'D020433', 'term': 'Trigeminal Nerve Diseases'}, {'id': 'D005156', 'term': 'Facial Neuralgia'}, {'id': 'D005155', 'term': 'Facial Nerve Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 186}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-11', 'studyFirstSubmitDate': '2019-02-06', 'studyFirstSubmitQcDate': '2019-02-11', 'lastUpdatePostDateStruct': {'date': '2019-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in overall burden of pain NRS over a two-year period', 'timeFrame': '2 years', 'description': 'Defined as a good outcome, i.e number of patients who had a reduction of minimum 50% on the NRS two years after enrolment in the management program compared with baseline'}], 'secondaryOutcomes': [{'measure': 'No changes of the overall burden of pain NRS over the two-year follow-up period', 'timeFrame': '2 years', 'description': 'Defined as poor outcome, i.e number of patients who had a no reduction the NRS two years after enrolment in the management program compared with baseline'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['multidisciplinary management', 'real-life study'], 'conditions': ['Trigeminal Neuralgia']}, 'referencesModule': {'references': [{'pmid': '30832577', 'type': 'DERIVED', 'citation': 'Heinskou TB, Maarbjerg S, Wolfram F, Rochat P, Brennum J, Olesen J, Bendtsen L. Favourable prognosis of trigeminal neuralgia when enrolled in a multidisciplinary management program - a two-year prospective real-life study. J Headache Pain. 2019 Mar 4;20(1):23. doi: 10.1186/s10194-019-0973-4.'}]}, 'descriptionModule': {'briefSummary': 'Background: Prognosis of medically treated trigeminal neuralgia patients is assumed to be poor, but the evidence is lacking. Thus, prospective real-life studies of medical management of trigeminal neuralgia are warranted.\n\nMethods: Observational study. Patients were consecutively enrolled in a structured management program at a specialist centre for facial pain. Optimisation of medical treatment, physiotherapy, psychotherapy, and advice from trained nurses, were parts of the program. Medically intractable patients were referred for neurosurgery. Data-collection was prospective using standardised schemes and patient surveys. The aim was to describe the two-year outcome of medical treatment at the specialist centre. The primary outcome was a 50% reduction in the overall burden of pain according to a Numerical Rating Scale (NRS) after two years.\n\nThis study aimed to provide evidence concerning the real-life efficacy of medical management of trigeminal neuralgia (TN) when directed by specialists. The investigatgors hypothesised that the two-year prognosis in a group of medically managed TN patients enrolled in a structured multidisciplinary management program was favourable, defined as a 50 % reduction of the overall burden of pain over a two-year period'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The diagnostic criteria used in this study were the beta version of the 3rd edition of the International Classification of Headache Disorders (ICHD-3-beta). Until the publication of IHCD-3-beta, ICHD 2 criteria were used. According to the ICHD-3 classification, this study included patients with both idiopathic and classical TN; in this paper termed primary TNThe number of patients enrolled in the inclusion period determined the sample size.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n1. recordings of the intensity of pain at enrolment of the programme (baseline recording),\n2. a two-year assessment (end-point recording),\n3. recording of effect and side-effects of drug treatment (at baseline and endpoint).\n\nThe exclusion criteria\n\n1. initiation of medical treatment at the DHC before May 2012,\n2. neurosurgical treatment of TN within the two-year follow-up\n3. incomplete two-year follow-up'}, 'identificationModule': {'nctId': 'NCT03838393', 'briefTitle': 'Prognosis of Trigeminal Neuralgia When Enrolled in a Multidisciplinary Management Program', 'organization': {'class': 'OTHER', 'fullName': 'Danish Headache Center'}, 'officialTitle': 'Prognosis of Trigeminal Neuralgia When Enrolled in a Multidisciplinary Management Program - a Two-year Prospective Real-life Study', 'orgStudyIdInfo': {'id': 'H-1-2012-093'}}, 'armsInterventionsModule': {'interventions': [{'name': 'multidisciplinary management', 'type': 'OTHER', 'description': 'pharmacological and non.pharmacological treatment (specially trained nurses, psychologists and physiologists)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Danish Headache Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'medical doctor', 'investigatorFullName': 'Tone Heinskou', 'investigatorAffiliation': 'Danish Headache Center'}}}}