Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2026-02-24 @ 11:41 AM
Study NCT ID:
NCT02424058
Status:
UNKNOWN
Last Update Posted:
2015-04-22
First Post:
2015-04-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Investigation of Thoracic Spinal Curvature and Mobility in Subjects With and Without Neck Pain: Cut-off Points
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'lastUpdateSubmitDate': '2015-04-18', 'studyFirstSubmitDate': '2015-04-12', 'studyFirstSubmitQcDate': '2015-04-18', 'lastUpdatePostDateStruct': {'date': '2015-04-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-04-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Thoracic curvature, as measured by Spinal Mouse®', 'timeFrame': 'participants will be followed for the duration of hospital stay, an expected average of one year'}], 'secondaryOutcomes': [{'measure': 'Pain, as measured by Visual Analog Scale', 'timeFrame': 'participants will be followed for the duration of hospital stay, an expected average of one year'}, {'measure': 'Thoracic mobility, as measured by Spinal Mouse®', 'timeFrame': 'participants will be followed for the duration of hospital stay, an expected average of one year'}]}, 'conditionsModule': {'conditions': ['Neck Pain']}, 'referencesModule': {'references': [{'pmid': '20430685', 'type': 'RESULT', 'citation': 'Lau KT, Cheung KY, Chan KB, Chan MH, Lo KY, Chiu TT. Relationships between sagittal postures of thoracic and cervical spine, presence of neck pain, neck pain severity and disability. Man Ther. 2010 Oct;15(5):457-62. doi: 10.1016/j.math.2010.03.009.'}, {'pmid': '25250268', 'type': 'RESULT', 'citation': 'Nejati P, Lotfian S, Moezy A, Moezy A, Nejati M. The relationship of forward head posture and rounded shoulders with neck pain in Iranian office workers. Med J Islam Repub Iran. 2014 May 3;28:26. eCollection 2014.'}, {'pmid': '23232803', 'type': 'RESULT', 'citation': 'Tsunoda D, Iizuka Y, Iizuka H, Nishinome M, Kobayashi R, Ara T, Yamamoto A, Takagishi K. Associations between neck and shoulder pain (called katakori in Japanese) and sagittal spinal alignment parameters among the general population. J Orthop Sci. 2013 Mar;18(2):216-9. doi: 10.1007/s00776-012-0341-6. Epub 2012 Dec 12.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the sagittal thoracic spinal curvature and mobility in subjects with and without chronic neck pain, cut-off points and pain relationship'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with Chronic neck pain and heatlhy subjects', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged between 18 and 65 years with persistent neck pain for more than 3 months\n* The inclusion criteria for the control group included acceptance to participate in the study, no previous neck pain (lifetime-to-date), no spinal surgery or deformity, and no radiological abnormalities detected\n\nExclusion Criteria:\n\n* Prior history of injury or surgery relating to spine, spinal deformity, neurological symptoms or signs, radiological abnormalities indicating cervical radiculopathy or myelopathy, prior history of other spinal disorder such as low back pain, active intervention in the last 3 months including drug therapy or physiotherapy, malignancy, systemic pathology including any rheumatologic disease and osteoporosis'}, 'identificationModule': {'nctId': 'NCT02424058', 'briefTitle': 'The Investigation of Thoracic Spinal Curvature and Mobility in Subjects With and Without Neck Pain: Cut-off Points', 'organization': {'class': 'OTHER', 'fullName': 'Ataturk Training and Research Hospital'}, 'officialTitle': 'The Investigation of the Sagittal Thoracic Spinal Curvature and Mobility in Subjects With and Without Chronic Neck Pain: Cut-off Points and Pain Relationship', 'orgStudyIdInfo': {'id': '2015-56/32'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Neck pain', 'description': 'Patients aged between 18 and 65 years with persistent neck pain for more than 3 months', 'interventionNames': ['Device: Spinal Mouse® measurement', 'Behavioral: Neck pain intensity measurement']}, {'label': 'Healthy', 'description': 'Acceptance to participate in the study, no previous neck oain (lifetime-to-date), no spinal surgery or deformity, and no radiological abnormalities detected', 'interventionNames': ['Device: Spinal Mouse® measurement']}], 'interventions': [{'name': 'Spinal Mouse® measurement', 'type': 'DEVICE', 'description': 'The sagittal thoracic spinal curvature and mobility of all participants were assessed with Spinal Mouse® (Idiag, Fehraltorf, Switzerland) in standing position.', 'armGroupLabels': ['Healthy', 'Neck pain']}, {'name': 'Neck pain intensity measurement', 'type': 'BEHAVIORAL', 'description': 'The neck pain intensity of the patients was questioned by Visual Analogue Scale', 'armGroupLabels': ['Neck pain']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06800', 'city': 'Ankara', 'state': 'Cankaya', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Seyda - TOPRAK CELENAY, Assist. Prof', 'role': 'CONTACT', 'email': 'sydtoprak@hotmail.com', 'phone': '+90 530 041 39 86'}, {'name': 'Derya - OZER KAYA, Assoc. Prof', 'role': 'CONTACT', 'email': 'deryaozer2000@yahoo.com', 'phone': '+90 232 329 35 13', 'phoneExt': '4711'}], 'facility': 'Ataturk Training and Research Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'centralContacts': [{'name': 'Seyda - TOPRAK CELENAY, Assist.Prof', 'role': 'CONTACT', 'email': 'sydtoprak@hotmail.com', 'phone': '+90 530 041 3986'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ataturk Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor, PT, PhD', 'investigatorFullName': 'Seyda TOPRAK CELENAY', 'investigatorAffiliation': 'Ataturk Training and Research Hospital'}}}}