Ignite Creation Date:
2025-12-24 @ 6:35 PM
Ignite Modification Date:
2026-03-02 @ 3:43 PM
Study NCT ID:
NCT02632357
Status:
COMPLETED
Last Update Posted:
2016-03-01
First Post:
2015-12-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Longitudinal Experimental Study on ULNTT and Cervico-Thoracic Spine Motion Patterns Relationship
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020968', 'term': 'Brachial Plexus Neuritis'}], 'ancestors': [{'id': 'D020516', 'term': 'Brachial Plexus Neuropathies'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009443', 'term': 'Neuritis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020393', 'term': 'Manipulation, Spinal'}], 'ancestors': [{'id': 'D026201', 'term': 'Musculoskeletal Manipulations'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-28', 'studyFirstSubmitDate': '2015-12-03', 'studyFirstSubmitQcDate': '2015-12-11', 'lastUpdatePostDateStruct': {'date': '2016-03-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-12-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Upper Limb Neural Tension Test at baseline: R2', 'timeFrame': 'Baseline', 'description': 'ULNTT are neurodynamics test of brachial plexus. Two parameters are collected during the procedure: firm resistance to elbow extension, named R2, operator dependent, and severe pain onset, named P2, patient dependent. Both results are expressed as degrees that left to full elbow extension. Four repetition per side are performed and average value is calculated.'}, {'measure': 'Upper Limb Neural Tension Test at baseline: P2', 'timeFrame': 'Baseline', 'description': 'ULNTT are neurodynamics test of brachial plexus. Two parameters are collected during the procedure: firm resistance to elbow extension, named R2, operator dependent, and severe pain onset, named P2, patient dependent. Both results are expressed as degrees that left to full elbow extension. Four repetition per side are performed and average value is calculated.'}, {'measure': 'Cervico-Thoracic Spine Lateral Bending at baseline', 'timeFrame': 'Baseline', 'description': 'Cervico-thoracic spine side bending is registered with motion-capture technology. Results are analyzed with Least Square Approximation tools and expressed as mathematical parameters in angles. Four repetition per side are performed and average value is calculated.'}, {'measure': 'Upper Limb Neural Tension Test after intervention: R2', 'timeFrame': 'Immediately after intervention, same day than baseline acquisition', 'description': 'ULNTT are neurodynamics test of brachial plexus. Two parameters are collected during the procedure: firm resistance to elbow extension, named R2, operator dependent, and severe pain onset, named P2, patient dependent. Both results are expressed as degrees that left to full elbow extension. Four repetition per side are performed and average value is calculated.'}, {'measure': 'Upper Limb Neural Tension Test after intervention: P2', 'timeFrame': 'Immediately after intervention, same day than baseline acquisition', 'description': 'ULNTT are neurodynamics test of brachial plexus. Two parameters are collected during the procedure: firm resistance to elbow extension, named R2, operator dependent, and severe pain onset, named P2, patient dependent. Both results are expressed as degrees that left to full elbow extension. Four repetition per side are performed and average value is calculated.'}, {'measure': 'Cervico-Thoracic Spine Lateral Bending after intervention', 'timeFrame': 'Immediately after intervention, same day than baseline acquisition', 'description': 'Cervico-thoracic spine side bending is registered with motion-capture technology. Results are analyzed with Least Square Approximation tools and expressed as mathematical parameters in angles. Four repetition per side are performed and average value is calculated.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Neurodynamics'], 'conditions': ['Cervicobrachial Neuralgia']}, 'descriptionModule': {'briefSummary': 'Study Design: Longitudinal Experimental Study\n\nObjective: Analyze the relationship between Upper Limb Neural Tension Test (ULNTT1) and cervico-thoracic spine biomechanics using a new motion-capture spine movement data analyzing model based on Least Square Approximation.\n\nSummary of Background Data: ULNTT1 is a test able to determine cervical nerve roots and brachial plexus displacement within their interface structures. No studies were conducted about ULNTT1 and cervico-thoracic spine motion patterns relationship.\n\nMethods: 12 subjects with ULNTT1 asymmetry \\> 10° (AS group) and 11 subjects with ULNTT1 symmetry (S group) at clinical tests will be enrolled for the study. Subjects will be analyzed for ULNTT1 with an electrogoniometer using two parameters, one operator and one patient-dependent. Fine lateral bending cervico-thoracic spine motion patterns will be collected with motion-capturing technique and data will be analyzed with Least Square Approximation tools. Subjects with impairments in cervico-thoracic spine mobility will undergo to correction of those with spinal manipulative therapy. ULNTT1 and spine mobility will be so re-evaluated with same methods.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* AS group: ULNTT asymmetry \\>10°\n* S group: ULNTT symmetry\n\nExclusion Criteria:\n\n* History of neck, shoulder or arm surgical interventions or major trauma, peripheral neuropathy, mental disturbance, limitation of shoulder, elbow or wrist range of motion, BMI \\>25.'}, 'identificationModule': {'nctId': 'NCT02632357', 'briefTitle': 'Longitudinal Experimental Study on ULNTT and Cervico-Thoracic Spine Motion Patterns Relationship', 'organization': {'class': 'OTHER', 'fullName': 'University of Milano Bicocca'}, 'officialTitle': 'Longitudinal Experimental Study on ULNTT1 and Cervico-Thoracic Spine Motion Patterns Relationship', 'orgStudyIdInfo': {'id': 'UMilanoBicocca'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AS group', 'description': 'Subjects with ULNTT asymmetry \\> 10°', 'interventionNames': ['Other: Spinal Manipulation']}, {'type': 'NO_INTERVENTION', 'label': 'S group', 'description': 'Subjects with ULNTT symmetry'}], 'interventions': [{'name': 'Spinal Manipulation', 'type': 'OTHER', 'armGroupLabels': ['AS group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20841', 'city': 'Carate Brianza', 'state': 'MB', 'country': 'Italy', 'facility': 'Istituti Clinici Zucchi', 'geoPoint': {'lat': 45.67574, 'lon': 9.23723}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Milano Bicocca', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Massimo Rossi', 'investigatorAffiliation': 'University of Milano Bicocca'}}}}