Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 10:19 PM
Study NCT ID:
NCT01060358
Status:
COMPLETED
Last Update Posted:
2013-02-07
First Post:
2010-01-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Assessment of Spinal Stability
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008722', 'term': 'Methods'}], 'ancestors': [{'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-01', 'completionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-02-05', 'studyFirstSubmitDate': '2010-01-29', 'studyFirstSubmitQcDate': '2010-01-29', 'lastUpdatePostDateStruct': {'date': '2013-02-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-02-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'neuromuscular neutral zones', 'timeFrame': 'one year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['lumbar spine', 'low back pain'], 'conditions': ['Spine Stability', 'Low Back Pain']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to verify the existence of neuromuscular neutral zones(NNZs) in humans, and develop non-invasive techniques to measure intervertebral kinematics of the lumbar spine. The results will be used to accurately quantify NNZs in humans, and provide a foundation for clinical trials on low back pain patients using this methodology.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '21 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Healty men and women between 21 and 45 years old with no history of low back pain of low back injury.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 21-45 years of age - typical working age in physically demanding jobs\n* no history of low back injury or musculoskeletal disorder in the past one year\n* any activity history: sedentary, active, or non-athletic, and 4) any ethnic background or race\n* body mass index score less than 30\n\nExclusion Criteria:\n\n* Younger than 21 or older than 45 years old (range not relevant to majority of physical labor force)\n* previous injury, disorder, or illness related to the low back\n* professional athletes\n* professional workers engaged in physical labor (e.g., roofers, loaders/unloaders in warehouses, tile/concrete layers, etc.)\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT01060358', 'briefTitle': 'Assessment of Spinal Stability', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Denver'}, 'officialTitle': 'Neuromuscular Neutral Zones in Humans: A New Method to Assess Spinal Stability', 'orgStudyIdInfo': {'id': '08-0063'}, 'secondaryIdInfos': [{'id': '2586067', 'type': 'OTHER', 'domain': 'UC Denver Project Number'}, {'id': 'K99AT004983', 'link': 'https://reporter.nih.gov/quickSearch/K99AT004983', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'healthy', 'description': 'Healthy and active men and women between 21 and 45 years old with no history of low back pain or low back injury.', 'interventionNames': ['Procedure: method (non-surgical) to measure neuromuscular neutral zones']}], 'interventions': [{'name': 'method (non-surgical) to measure neuromuscular neutral zones', 'type': 'PROCEDURE', 'armGroupLabels': ['healthy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Denver', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}], 'overallOfficials': [{'name': 'Bradley Davidson, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado, Denver'}, {'name': 'Moshe Solomonow, Ph.D., M.D. (hon)', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado, Denver'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Center for Complementary and Integrative Health (NCCIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}