Ignite Creation Date:
2025-12-24 @ 10:20 PM
Ignite Modification Date:
2026-01-25 @ 6:20 AM
Study NCT ID:
NCT02701335
Status:
UNKNOWN
Last Update Posted:
2016-08-26
First Post:
2016-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Manual Therapy for Hand Osteoarthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2016-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2018-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-08-25', 'studyFirstSubmitDate': '2016-02-27', 'studyFirstSubmitQcDate': '2016-03-02', 'lastUpdatePostDateStruct': {'date': '2016-08-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-03-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Pain intensity at 3 months', 'timeFrame': 'baseline, immediately post-intervention, and at 1- and 3-month post-interventions, Baseline up to 5 minutes.', 'description': 'visual analogue scale'}, {'measure': 'Change from QuickDASH questionnaire at 3 months', 'timeFrame': 'baseline, immediately post-intervention, and at 1- and 3-month post-interventions Baseline, up to 5 minutes.', 'description': 'will be used to measure upper extremity function'}, {'measure': 'Change from Pressure Pain Thresholds (PPT) at 3 months', 'timeFrame': 'Baseline and immediately post-interventionand, at 1- and 3-month post-interventions.', 'description': 'is a quantitative sensory test of tissue sensitivity and it is defined as the minimal amount of pressure that produces pain, measured via a pressure algometer. PPT will be assessed bilaterally over the hand (first CMC at the center of the anatomical snuffbox, and unciform apophysis of the hamate bone), the C5-C6 zygapophyseal joint, the median, ulnar and radial nerves, and tibialis anterior muscle by an assessor blinded to the subjects condition.'}], 'secondaryOutcomes': [{'measure': 'Motor conduction velocity', 'timeFrame': 'Baseline up to 5 minutes'}, {'measure': 'Range of Motion', 'timeFrame': 'Baseline up to 5 minutes'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Osteoarthritis', 'Hand', 'Rehabilitation'], 'conditions': ['Hand Osteoarthritis']}, 'referencesModule': {'references': [{'pmid': '31675184', 'type': 'DERIVED', 'citation': 'Pedersini P, Valdes K, Cantero-Tellez R, Cleland JA, Bishop MD, Villafane JH. Effects of Neurodynamic Mobilizations on Pain Hypersensitivity in Patients With Hand Osteoarthritis Compared to Robotic Assisted Mobilization: A Randomized Controlled Trial. Arthritis Care Res (Hoboken). 2021 Feb;73(2):232-239. doi: 10.1002/acr.24103. Epub 2021 Jan 3.'}]}, 'descriptionModule': {'briefSummary': 'Osteoarthritis (OA) of the hand is a major cause of pain and functional limitation, central sensitization of pain can be one of the causes: this hypothesis opens avenues for research in the modulation of pain pathways. The peripherally directed therapies may modulate pain perception bilaterally. This hypothesis opens avenues for future research in the modulation of pain pathways, perhaps offering targets to optimize peripheral manual and physical therapies for pain management in hand OA.\n\nSeveral studies have reported the outcomes of multimodal approach to central sensitization evaluated by generalized pressure pain hypersensitivity in patients with carpometacarpal (CMC) OA. Neurodynamic techniques are a form of manual therapy directed to the neural structures through positioning and movement of multiple joints. Recent technologies have facilitated the use of robots as tools to assist patients in the rehabilitation process thus maximizing patient outcomes. These robotic tools assist the patient with carrying out exercise protocols, optimal for the activity of the control group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Osteoarthritis of the dominant hand. To be included in the study, the subjects need to have a history of repetitive use of their dominant hand (eg, ex-factory worker) and a diagnosis of hand OA in the dominant hand, according on radiographic findings.\n\nExclusion Criteria:\n\n* If they score greater than 6 points on the Beck Depression Inventory (BDI) or more than 30 points in the State Trait Anxiety Inventory (STAI). Patients with a medical history of carpal tunnel syndrome, surgical interventions to the hand, DeQuervain's tenosynovitis, or with degenerative or non-degenerative neurological conditions in which pain perception is altered will be excluded. None of the individuals in this study will have received prior interventions for hand OA."}, 'identificationModule': {'nctId': 'NCT02701335', 'briefTitle': 'Manual Therapy for Hand Osteoarthritis', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Don Carlo Gnocchi Onlus'}, 'officialTitle': 'Neural Manual vs. Robotic Assisted Mobilization to Improve Hand Range of Motion and Reduce Pain Hypersensitivity in Hand Osteoarthritis: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'Project Code:GR-2013-02358472'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental group', 'description': 'Neural mobilization and standardized exercise . 12 sessions over 4 weeks (3 sessions per week).', 'interventionNames': ['Device: Neural mobilization', 'Device: Standardized exercise']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'Gloreha device and standardized exercise. 12 sessions over 4 weeks (3 sessions per week).', 'interventionNames': ['Device: Gloreha device', 'Device: Standardized exercise']}], 'interventions': [{'name': 'Neural mobilization', 'type': 'DEVICE', 'description': 'The first 6 exercises consist of active range of motion movements of the hand designed to improve joint flexibility. The remaining 3 exercises are designed to strengthen grip and pinch by using a non-latex polymer ball: the Thera-Band Hand Exerciser (The Hygenic Corporation, Akron, OH) Subjects began with 10 repetitions the first 4 sessions, progressed to 12 repetitions the next 2 sessions, then 15 (2 sessions), and finally 20, if able, during the last sessions.', 'armGroupLabels': ['Experimental group']}, {'name': 'Gloreha device', 'type': 'DEVICE', 'description': 'Robotic assisted passive mobilization.', 'armGroupLabels': ['Control group']}, {'name': 'Standardized exercise', 'type': 'DEVICE', 'description': '9 exercises: active range of motion, strengthen grip and pinch', 'armGroupLabels': ['Control group', 'Experimental group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10045', 'city': 'Piossasco', 'state': 'Turin', 'country': 'Italy', 'facility': 'Jorge Hugo Villafañe', 'geoPoint': {'lat': 44.98802, 'lon': 7.4601}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Don Carlo Gnocchi Onlus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Researcher', 'investigatorFullName': 'Jorge Hugo Villafañe, PhD', 'investigatorAffiliation': 'Fondazione Don Carlo Gnocchi Onlus'}}}}