Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2026-01-01 @ 3:28 AM
Study NCT ID:
NCT05370833
Status:
UNKNOWN
Last Update Posted:
2023-07-12
First Post:
2022-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transcranial Direct Current Stimulation in Clinical Setting to Reduce Pain in Older Workers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D065908', 'term': 'Transcranial Direct Current Stimulation'}], 'ancestors': [{'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D003295', 'term': 'Convulsive Therapy'}, {'id': 'D013000', 'term': 'Psychiatric Somatic Therapies'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D004597', 'term': 'Electroshock'}, {'id': 'D011580', 'term': 'Psychological Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2024-05-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-10', 'studyFirstSubmitDate': '2022-04-11', 'studyFirstSubmitQcDate': '2022-05-06', 'lastUpdatePostDateStruct': {'date': '2023-07-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain intensity', 'timeFrame': 'Before tDCS', 'description': '0-10 Numerical rating scale'}, {'measure': 'Pain intensity', 'timeFrame': '1 week', 'description': '0-10 Numerical rating scale'}, {'measure': 'Pain intensity', 'timeFrame': '4 weeks', 'description': '0-10 Numerical rating scale'}, {'measure': 'Pain intensity', 'timeFrame': '4 weeks after the last tDCS session', 'description': '0-10 Numerical rating scale'}, {'measure': 'Disability', 'timeFrame': 'Before tDCS', 'description': 'Pain Disability Index'}, {'measure': 'Disability', 'timeFrame': '1 week', 'description': 'Pain Disability Index'}, {'measure': 'Disability', 'timeFrame': '4 weeks', 'description': 'Pain Disability Index'}, {'measure': 'Disability', 'timeFrame': '4 weeks after the last tDCS session', 'description': 'Pain Disability Index'}, {'measure': 'Work role functioning', 'timeFrame': 'Before tDCS', 'description': 'Work Role Functioning Questionnaire'}, {'measure': 'Work role functioning', 'timeFrame': '1 week', 'description': 'Work Role Functioning Questionnaire'}, {'measure': 'Work role functioning', 'timeFrame': '4 weeks', 'description': 'Work Role Functioning Questionnaire'}, {'measure': 'Work role functioning', 'timeFrame': '4 weeks after the last tDCS session', 'description': 'Work Role Functioning Questionnaire'}, {'measure': 'Physical Functioning', 'timeFrame': 'Before tDCS', 'description': 'Brief Pain Inventory'}, {'measure': 'Physical Functioning', 'timeFrame': '1 week', 'description': 'Brief Pain Inventory'}, {'measure': 'Physical Functioning', 'timeFrame': '4 weeks', 'description': 'Brief Pain Inventory'}, {'measure': 'Physical Functioning', 'timeFrame': '4 weeks after the last tDCS session', 'description': 'Brief Pain Inventory'}, {'measure': 'Anxiety', 'timeFrame': 'Before tDCS', 'description': 'Beck anxiety inventory'}, {'measure': 'Anxiety', 'timeFrame': '1 week', 'description': 'Beck anxiety inventory'}, {'measure': 'Anxiety', 'timeFrame': '4 weeks', 'description': 'Beck anxiety inventory'}, {'measure': 'Anxiety', 'timeFrame': '4 weeks after the last tDCS session', 'description': 'Beck anxiety inventory'}, {'measure': 'Depression', 'timeFrame': 'Before tDCS', 'description': 'Beck depression inventory'}, {'measure': 'Depression', 'timeFrame': '1 week', 'description': 'Beck depression inventory'}, {'measure': 'Depression', 'timeFrame': '4 weeks', 'description': 'Beck depression inventory'}, {'measure': 'Depression', 'timeFrame': '4 weeks after the last tDCS session', 'description': 'Beck depression inventory'}, {'measure': 'Impression of change', 'timeFrame': '1 week', 'description': 'Patient Global impression of change'}, {'measure': 'Impression of change', 'timeFrame': '4 weeks', 'description': 'Patient Global impression of change'}, {'measure': 'Impression of change', 'timeFrame': '4 weeks after the last tDCS session', 'description': 'Patient Global impression of change'}, {'measure': 'Central sensitization', 'timeFrame': 'Before tDCS', 'description': 'central sensitization inventory'}, {'measure': 'Central sensitization', 'timeFrame': '1 week', 'description': 'central sensitization inventory'}, {'measure': 'Central sensitization', 'timeFrame': '4 weeks', 'description': 'central sensitization inventory'}, {'measure': 'Central sensitization', 'timeFrame': '4 weeks after the last tDCS session', 'description': 'central sensitization inventory'}], 'secondaryOutcomes': [{'measure': 'Recruitment', 'timeFrame': 'through study completion, about 2 years', 'description': 'Feasibility of the study'}, {'measure': 'Security', 'timeFrame': 'through study completion, about 2 years', 'description': 'Feasibility of the study'}, {'measure': 'Intervention', 'timeFrame': 'through study completion, about 2 years', 'description': 'Feasibility of the study'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['transcranial direct current stimulation', 'physical therapy', 'work retention'], 'conditions': ['Chronic Pain', 'Aging']}, 'descriptionModule': {'briefSummary': "Chronic pain is one of the main factors influencing workers' retention at work. Considering that the prevalence of suffering from chronic pain increases with age, older workers are most likely to be absent from work because of their pain.\n\nTranscranial direct current stimulation (tDCS) is a treatment option to reduce chronic pain.\n\nThis study aims to document the effect of tDCS on pain and work retention in older workers and to compare the traditional tDCS protocol (5 sessions) with an enhanced protocol (11 sessions).", 'detailedDescription': 'Chronic pain affects many spheres of the lives of affected individuals and those around them. In Canada, the prevalence of chronic pain is estimated at 15% of adults aged 18 and over. Among seniors, the prevalence of this health problem can reach up to 50% and affect one in two seniors. Chronic pain is one of the leading causes of work disability. In this context, pain reduction remains one of the most effective methods to enable the worker to stay at work. Considering the aging Quebec population, labor needs and the average retirement age which is increasingly postponed, it becomes crucial to take an interest in aging workers and their continued employment.\n\nTranscranial direct current stimulation (tDCS) is a non-invasive neurostimulation method that has shown promise in reducing chronic pain. Recently, several research teams have shown that tDCS has beneficial effects on pain, physical function and social participation in seniors. Despite all these recent advances, very few studies have focused on optimizing tDCS treatment modalities and no studies have focused on the impact of tDCS on return to work or retention. The vast majority of studies using tDCS to reduce pain give one tDCS session per day for 5 consecutive days. This study aims to document the effect of tDCS on pain and work retention in older workers and to compare the traditional tDCS protocol (5 sessions) with an enhanced protocol (11 sessions).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '56 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* To be more than 55 years old\n* To have chronic pain\n* To have employment relationship\n* To have pain that interferes with work tasks\n\nExclusion Criteria:\n\n\\- tDCS contraindications (epilepsy, metallic implant in the head, pacemaker, cochlear implant)'}, 'identificationModule': {'nctId': 'NCT05370833', 'briefTitle': 'Transcranial Direct Current Stimulation in Clinical Setting to Reduce Pain in Older Workers', 'organization': {'class': 'OTHER', 'fullName': 'Université de Sherbrooke'}, 'officialTitle': 'Observation et Analyse Des Effets de la Stimulation transcrânienne à Courant Continu en Milieu Clinique Pour Soulager la Douleur Chronique Chez Les Travailleurs Vieillissants', 'orgStudyIdInfo': {'id': 'MP-31-2022-4640'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Standard protocol', 'description': '5 tDCS sessions in 1 week', 'interventionNames': ['Device: transcranial direct current stimulation']}, {'type': 'EXPERIMENTAL', 'label': 'Enhanced protocol', 'description': '11 tDCS sessions devised in 4 weeks', 'interventionNames': ['Device: transcranial direct current stimulation']}], 'interventions': [{'name': 'transcranial direct current stimulation', 'type': 'DEVICE', 'description': 'Anodal, 2mA, tDCS session applied on M1 for 20 minutes.', 'armGroupLabels': ['Enhanced protocol', 'Standard protocol']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Rouyn-Noranda', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Rodrigo Deamo, PhD', 'role': 'CONTACT'}], 'facility': 'Clinique régionale de la gestion de la douleur - CISSSAT', 'geoPoint': {'lat': 48.23656, 'lon': -79.02311}}, {'zip': 'J1H 4C4', 'city': 'Sherbrooke', 'state': 'Quebec', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Canada', 'facility': 'Centre de Recherche sur le Vieillissement', 'geoPoint': {'lat': 45.40008, 'lon': -71.89908}}], 'centralContacts': [{'name': 'Guillaume Leonard, PhD', 'role': 'CONTACT', 'email': 'guillaume.leonard2@usherbrooke.ca', 'phone': '819-780-2220', 'phoneExt': '45246'}], 'overallOfficials': [{'name': 'Guillaume Leonard, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Université de Sherbrooke'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'Upon request', 'ipdSharing': 'YES', 'description': 'Upon request to the corresponding author'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Université de Sherbrooke', 'class': 'OTHER'}, 'collaborators': [{'name': 'CISSS Abitibi-Témiscamingue', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Guillaume Léonard', 'investigatorAffiliation': 'Université de Sherbrooke'}}}}