Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2026-02-01 @ 3:41 PM
Study NCT ID:
NCT01745705
Status:
COMPLETED
Last Update Posted:
2013-06-19
First Post:
2012-12-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cervical Spine Manipulation Affects on Balance and Proprioception
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019547', 'term': 'Neck Pain'}, {'id': 'D006261', 'term': 'Headache'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-17', 'studyFirstSubmitDate': '2012-12-05', 'studyFirstSubmitQcDate': '2012-12-07', 'lastUpdatePostDateStruct': {'date': '2013-06-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-12-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'SMART Neurocom Balance Master', 'timeFrame': '1 day (Immediately after the intervention)', 'description': 'Subjects stand on a force plate on a SMART Neurocom Balance Master and complete a Sensory Organization Test (SOT) program which assesses somatosensory, visual and vestobular systems used in maintaining balance.'}], 'primaryOutcomes': [{'measure': 'Cervical joint proprioception', 'timeFrame': '1 day (Immediately after the intervention)', 'description': 'Subjects wear a headband with a mounted laser pointer and sit 1 meter away from a wall. They assume their comfortable neutral cervical posture and then close their eyes and extend their cervical spine and return to their neutral posture with eyes closed. The laser pointer marks the point of return and we measure the difference between start and end points for error.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Manipulation', 'Balance', 'Proprioception'], 'conditions': ['Neck Pain', 'Headache']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://pt.unlv.edu/louie.htm', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': "Cervical spine manipulation (CSM) is utilized by many health care practitioners in the management of patients with neck pain and headache. How CSM works is not understood however, most researchers agree that there is likely a combination of mechanical, neurophysiological and placebo effects. This study will test for possible neurophysiological effects by examining for changes in a person's ability to reposition their head and neck in space, and maintain their balance following CSM.", 'detailedDescription': 'Consenting participants will have their proprioception tested through a joint repositioning error test for their cervical spine, and also have their balance tested through a Neurocom Balancemaster. Following these pre-intervention measures, they will receive in a random order, either a cervical spine manipulation (CSM) or a sham manipulation, and then have tests repeated to analyze for changes and differences between interventions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy individuals between the ages of 18 and 60\n\nExclusion Criteria:\n\n* current neck pain/symptoms; neck pain symptoms within the last 6 months; confirmation or possibility of pregnancy; dizziness; vertigo, or nausea; history of cervical spine surgery; rheumatoid arthritis; osteoporosis; osteopenia; ankylosing spondylitis; cancer; or vertebral artery insufficiency.'}, 'identificationModule': {'nctId': 'NCT01745705', 'briefTitle': 'Cervical Spine Manipulation Affects on Balance and Proprioception', 'organization': {'class': 'OTHER', 'fullName': 'University of Nevada, Las Vegas'}, 'officialTitle': 'Immediate Effects of Cervical Spine Manipulation on Balance and Joint Proprioception in Healthy Individuals', 'orgStudyIdInfo': {'id': '1105-3780'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cervical Spine Manipulation', 'description': 'Subjects will lie supine on a treatment table and receive a high velocity low amplitude thrust joint manipulation to their cervical spine in rotation to each side of the neck.', 'interventionNames': ['Other: Cervical Spine Manipulation']}, {'type': 'SHAM_COMPARATOR', 'label': 'Manual Contact', 'description': 'Subjects will lie supine on a treatment table and have their suboccipital region gently cupped by the therapist for 30 seconds. No movement or force will be applied, just simple manual contact.', 'interventionNames': ['Other: Manual Contact']}], 'interventions': [{'name': 'Cervical Spine Manipulation', 'type': 'OTHER', 'armGroupLabels': ['Cervical Spine Manipulation']}, {'name': 'Manual Contact', 'type': 'OTHER', 'armGroupLabels': ['Manual Contact']}]}, 'contactsLocationsModule': {'locations': [{'zip': '89154', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Department of Physical Therapy, University of Nevada Las Vegas', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Nevada, Las Vegas', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Emilio', 'investigatorAffiliation': 'University of Nevada, Las Vegas'}}}}