Ignite Creation Date:
2025-12-24 @ 11:09 PM
Ignite Modification Date:
2026-01-05 @ 5:47 PM
Study NCT ID:
NCT03127969
Status:
COMPLETED
Last Update Posted:
2017-04-25
First Post:
2017-04-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Is Fluidotherapy Effective in Rheumatoid Hand?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 93}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-02-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2013-06-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-20', 'studyFirstSubmitDate': '2017-04-04', 'studyFirstSubmitQcDate': '2017-04-20', 'lastUpdatePostDateStruct': {'date': '2017-04-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-06-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Health Assessment Questionnaire (HAQ)', 'timeFrame': 'Change from Baseline, Health Assessment Questionnaire score at 3 weeks and 12 weeks'}, {'measure': 'Duruöz Hand Index (DHI)', 'timeFrame': 'Change from Baseline. Duruöz Hand Index score at 3 weeks and 12 weeks'}], 'secondaryOutcomes': [{'measure': 'pain', 'timeFrame': 'baseline, at week 3 and week 12', 'description': 'Visual Analog Scale (VAS, 0-100 mm)'}, {'measure': 'stiffness', 'timeFrame': 'baseline, at week 3 and week 12', 'description': 'Visual Analog Scale (VAS, 0-100 mm)'}, {'measure': 'Grip Ability Test (GAT)', 'timeFrame': 'baseline, at week 3 and week 12'}, {'measure': 'Disease Activity Score-28 (DAS-28)', 'timeFrame': 'baseline, at week 3 and week 12'}, {'measure': 'grip strength', 'timeFrame': 'baseline, at week 3 and week 12', 'description': 'Jamar measure'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Rheumatoid hand', 'Fluidotherapy', 'Rehabilitation'], 'conditions': ['Rheumatoid Arthritis']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate the efficacy of fluidotherapy primarily on function and quality of life, secondarily on pain, morning stiffness, grip strength, and disease activity in patients with rheumatoid hand.Ninety-three patients were enrolled in this prospective, single-blind, randomized, and controlled trial. Patients were randomized into 2 groups. Group 1 (n=47) had fluidotherapy (5 times per week, for 3-week duration) and Group 2 (n=46) was the control group. All patients received joint protection and exercise program. The primary outcome measures were Health Assessment Questionnaire (HAQ) and Duruöz Hand Index (DHI) and secondary outcome measures were pain and morning stiffness assessed using the Visual Analog Scale (VAS, 0-100 mm), the Grip Ability Test (GAT), Disease Activity Score-28 (DAS-28), and grip strength. These assessments were performed at baseline, at week 3 and week 12 after treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age between 18-75 years RA diagnosis fulfilling ACR 2010 criteria\n* disease duration for at least 6 months\n* no high disease activity and no acute arthritis in the hand according to DAS-28\n* hand problem specified with pain and loss of function in the hand\n* being in an eligible sociocultural and socioeconomic state so as to be able to come to the ambulatory treatment program\n\nExclusion Criteria:\n\n* change of medication within the last 3 months or during the study (except for non-steroidal anti-inflammatory drugs and paracetamol)\n* changes in oral corticosteroid dose in the last month, intraarticular or intramuscular corticosteroid use\n* hand or upper extremity surgery in the last 6 months\n* previous injury in the hand or upper extremity in the last 6 months\n* pregnancy\n* presence of sensory defects in the hand\n* presence of cognitive and/or psychiatric disease\n* physical therapy for the hand in the last 3 months.'}, 'identificationModule': {'nctId': 'NCT03127969', 'briefTitle': 'Is Fluidotherapy Effective in Rheumatoid Hand?', 'organization': {'class': 'OTHER', 'fullName': 'Dokuz Eylul University'}, 'officialTitle': 'Is Fluidotherapy Effective in Rheumatoid Hand? A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'DorkuzEUftr1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Fluidotherapy treatment', 'description': 'Patients who received fluidotherapy and joint protection and exercise', 'interventionNames': ['Other: Fluidotherapy treatment', 'Other: Joint protection and exercise']}, {'type': 'OTHER', 'label': 'Joint protection and exercise', 'description': 'Patients who received joint protection and exercise', 'interventionNames': ['Other: Joint protection and exercise']}], 'interventions': [{'name': 'Fluidotherapy treatment', 'type': 'OTHER', 'description': 'fluidotherapy and joint protection and exercise', 'armGroupLabels': ['Fluidotherapy treatment']}, {'name': 'Joint protection and exercise', 'type': 'OTHER', 'description': 'joint protection and exercise', 'armGroupLabels': ['Fluidotherapy treatment', 'Joint protection and exercise']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Selmin Gulbahar', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor and Head of Department of Physical Medicine and Rehabilitation, Faculty of Medicine, Dokuz Eylul University', 'investigatorFullName': 'Selmin Gulbahar', 'investigatorAffiliation': 'Dokuz Eylul University'}}}}