Ignite Creation Date:
2025-12-24 @ 4:12 PM
Ignite Modification Date:
2025-12-28 @ 2:20 AM
Study NCT ID:
NCT01216566
Status:
UNKNOWN
Last Update Posted:
2010-10-07
First Post:
2010-06-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Computerized Mobilization of the Cervical Spine Utilizing the Occiflex Device for the Treatment of Chronic Neck Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2011-09-19', 'releaseDate': '2011-08-16'}, {'resetDate': '2012-08-21', 'releaseDate': '2012-07-18'}, {'resetDate': '2013-06-07', 'releaseDate': '2013-05-07'}, {'resetDate': '2013-10-28', 'releaseDate': '2013-08-22'}], 'estimatedResultsFirstSubmitDate': '2011-08-16'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D019547', 'term': 'Neck Pain'}], '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': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2010-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-10', 'completionDateStruct': {'date': '2011-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-10-06', 'studyFirstSubmitDate': '2010-06-01', 'studyFirstSubmitQcDate': '2010-10-06', 'lastUpdatePostDateStruct': {'date': '2010-10-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-10-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety of computerized continuous mobilization of the cervical spine', 'timeFrame': 'one year'}], 'secondaryOutcomes': [{'measure': 'Efficacy of computerized mobilization of treatment of patients with chronic neck pain', 'timeFrame': 'one year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Neck Pain']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the efficacy and safety of the Occiflex device in the treatment of neck pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with chronic neck pain: post-whiplash injury, myofacial pain, cervical facet joint disease and idiopathic chronic neck pain\n\nExclusion Criteria:\n\n* Radiculopathy\n* Myelopathy\n* Cerebral vascular disease\n* Malignancy\n* Osteoporosis\n* Cervical disc herniation'}, 'identificationModule': {'nctId': 'NCT01216566', 'briefTitle': 'Computerized Mobilization of the Cervical Spine Utilizing the Occiflex Device for the Treatment of Chronic Neck Pain', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Hillel Yaffe Medical Center'}, 'orgStudyIdInfo': {'id': 'HYMC-0030-10'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'I. Patients with chronic neck pain', 'interventionNames': ['Device: Occiflex Device']}], 'interventions': [{'name': 'Occiflex Device', 'type': 'DEVICE', 'description': 'This device is a computerized robotic platform that allows continuous mobilization of the cervical spine in a three dimensional space. The patients undergoes biweekly 20 minute therapeutic session for 6 weeks', 'armGroupLabels': ['I. Patients with chronic neck pain']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38100', 'city': 'Hadera', 'country': 'Israel', 'contacts': [{'name': 'Yaron M River, MD', 'role': 'CONTACT', 'email': 'yaron60@netvision.net.il', 'phone': '972-4-6304427'}, {'name': 'Jill Bracha, PT', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Hillel Yaffe Medical Center', 'geoPoint': {'lat': 32.44192, 'lon': 34.9039}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hillel Yaffe Medical Center', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Headway Ltd.', 'class': 'UNKNOWN'}], 'responsibleParty': {'oldNameTitle': 'Yaron River, MD', 'oldOrganization': 'Dept. of Neurology, Hillel Yaffe Medical Center'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2011-08-16', 'type': 'RELEASE'}, {'date': '2011-09-19', 'type': 'RESET'}, {'date': '2012-07-18', 'type': 'RELEASE'}, {'date': '2012-08-21', 'type': 'RESET'}, {'date': '2013-05-07', 'type': 'RELEASE'}, {'date': '2013-06-07', 'type': 'RESET'}, {'date': '2013-08-22', 'type': 'RELEASE'}, {'date': '2013-10-28', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Hillel Yaffe Medical Center'}}}}