Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-31 @ 7:22 PM
Study NCT ID:
NCT01784094
Status:
COMPLETED
Last Update Posted:
2014-12-30
First Post:
2013-01-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Connective Tissue Motion Measure 2
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}, {'id': 'D059352', 'term': 'Musculoskeletal Pain'}], 'ancestors': [{'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 195}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-29', 'studyFirstSubmitDate': '2013-01-30', 'studyFirstSubmitQcDate': '2013-02-01', 'lastUpdatePostDateStruct': {'date': '2014-12-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-02-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Connective Tissue Shear Strain Motion', 'timeFrame': 'Baseline'}, {'measure': 'Change in Connective Tissue Shear Strain Motion', 'timeFrame': 'Baseline to 1 hour'}, {'measure': 'Change in Connective Tissue Shear Strain Motion', 'timeFrame': 'Baseline to one day'}, {'measure': 'Change in Connective Tissue Shear Strain Motion', 'timeFrame': 'Baseline to one week'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Low Back Pain', 'Musculoskeletal Pain']}, 'descriptionModule': {'briefSummary': 'This study aims to compare the Connective Tissue Motion Measure (CTMM) in low back pain and no-low back pain subjects, evaluate the reliability of the CTMM, and examine the correlation of CTMM with low back pain symptoms, disability, and functional measures. The investigators hypothesize that CTMM will be reduced, on average, in low back pain subjects, that CTMM will be reliable with an intra-class correlation greater than 0.8, and CTMM will negatively correlate with low back pain symptoms, disability and functional measures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Community sample', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria for all subjects:\n\n* able to stand and walk without assistance\n* able to read and understand English\n* able to understand and sign a consent form\n\nInclusion Criteria for low back pain subjects:\n\n* history of recurrent or chronic low back pain\n\nInclusion criteria for no-low back pain subjects:\n\n* no history of low back pain or other chronic pain that has limited activities of daily living or work\n* numerical chronic pain index of less than 0.5\n\nExclusion Criteria for all subjects:\n\n* previous severe back or lower extremity injury or surgery\n* major structural spinal deformity (scoliosis, kyphosis, stenosis)\n* ankylosing spondylitis or rheumatoid arthritis\n* neurological deficit (weakness or sensory loss, decreased deep tendon reflexes suggesting nerve root compression, but not subjective symptoms of nerve root irritation (sciatica))\n* radicular pain\n* neurological or major psychiatric disorder\n* bleeding disorders\n* corticosteroid or anticoagulant medication\n* substance abuse\n* pregnancy\n* active worker's compensation or disability case\n* in litigation for a low back pain problem\n* acute systemic infection"}, 'identificationModule': {'nctId': 'NCT01784094', 'briefTitle': 'Connective Tissue Motion Measure 2', 'organization': {'class': 'INDUSTRY', 'fullName': 'Stromatec, Inc.'}, 'orgStudyIdInfo': {'id': '2R44AT006085', 'link': 'https://reporter.nih.gov/quickSearch/2R44AT006085', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Low back pain subjects', 'description': 'Subjects with chronic or recurrent low back pain', 'interventionNames': ['Device: StromaGlide']}, {'label': 'No low back pain subjects', 'description': 'Subjects who are generally healthy with no low back pain', 'interventionNames': ['Device: StromaGlide']}], 'interventions': [{'name': 'StromaGlide', 'type': 'DEVICE', 'armGroupLabels': ['Low back pain subjects', 'No low back pain subjects']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05401', 'city': 'Burlington', 'state': 'Vermont', 'country': 'United States', 'facility': 'Stromatec, Inc', 'geoPoint': {'lat': 44.47588, 'lon': -73.21207}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stromatec, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'National Center for Complementary and Integrative Health (NCCIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Robert Davis', 'investigatorAffiliation': 'Stromatec, Inc.'}}}}