Ignite Creation Date:
2025-12-24 @ 11:51 AM
Ignite Modification Date:
2025-12-29 @ 9:30 AM
Study NCT ID:
NCT04886661
Status:
UNKNOWN
Last Update Posted:
2021-06-29
First Post:
2021-05-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Correlation of Cervical Lordosis Degree Detected on Cervical X-Ray Image With Clinical, Demographic and MRI Findings
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2023-07-05', 'releaseDate': '2022-08-04'}], 'estimatedResultsFirstSubmitDate': '2022-08-04'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D019547', 'term': 'Neck Pain'}, {'id': 'D007405', 'term': 'Intervertebral Disc Displacement'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 125}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-06-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2021-07-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-06-26', 'studyFirstSubmitDate': '2021-05-05', 'studyFirstSubmitQcDate': '2021-05-10', 'lastUpdatePostDateStruct': {'date': '2021-06-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'C2-C7 COBB ANGLE', 'timeFrame': '1 week', 'description': 'MEASURING C2-C7 COBB ANGLE ON LATERAL CERVICAL X-RAY IMAGE'}, {'measure': 'C2-C7 POSTERIOR TANJANT ANGLE', 'timeFrame': '1 week', 'description': 'MEASURING C2-C7 POSTERIOR TANJANT ANGLE ON LATERAL CERVICAL X-RAY IMAGE'}, {'measure': 'C2-C7 CERVICAL VERTEBRAL ALIGNMENT (CVA)', 'timeFrame': '1 week', 'description': 'C2-C7 CERVICAL VERTEBRAL ALIGNMENT ON LATERAL CERVIKAL X-RAY IMAGE'}, {'measure': 'CERVICAL HERNIATION LEVEL', 'timeFrame': '1 week', 'description': 'CERVICAL HERNIATION LEVEL ON CERVICAL MRI'}, {'measure': 'CERVICAL HERNIATION DEGREE', 'timeFrame': '1 week', 'description': 'CERVICAL HERNIATION DEGREE ON CERVICAL MRI: BULGING,PROTRUSION, SECESTRATION, EXTRUDATION'}], 'secondaryOutcomes': [{'measure': 'DEMOGRAPHIC FINDINGS', 'timeFrame': '1 week', 'description': 'AGE'}, {'measure': 'SCREEN TIME', 'timeFrame': '1 week', 'description': 'AVARAGE TIME SPENT ON TV, COMPUTER AND MOBILE PHONE DURING A DAY IN HOURS'}, {'measure': 'VISUAL ANALOG SCALE (VAS)', 'timeFrame': '1 week', 'description': 'VISUAL ANALOG SCALE SCORE FOR THE NECK PAIN FROM 1-10'}, {'measure': 'NECK DISABILITY INDEX (NDI)', 'timeFrame': '1 week', 'description': 'NECK DISABILITY INDEX SCORE'}, {'measure': 'DURATION OF THE NECK PAIN', 'timeFrame': '1 week', 'description': 'HOW LONG DOES THE PATIENT FEELS THE NECK PAIN IN MONTHS'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['neck pain', 'cervical sagittal balance', 'trigger points', 'flex head posture'], 'conditions': ['Neck Pain', 'Cervical Lordosis', 'Disk, Herniated']}, 'descriptionModule': {'briefSummary': "In this study we are investigating whether there is a relationship between the lordosis angle measured on cervical X-RAY images on the severity and level of cervical disc herniation detected by cervical MRI, demographic characteristics and the duration and posture of the person's daily life activities.", 'detailedDescription': 'At least 125 patients between the ages of 18-65 who meet the inclusion criteria with cervical cervical X-RAY and cervical MRIs taken in the last 3 months will be included in the study.\n\nThe demographic characteristics of the patients such as age, gender, BMI, job, education level, marital status, as well as the time they spend on head flexion posture, and their screen time will be questioned. The presence of active trigger points in the cervical muscles will be determined by examination (levator scapula, trapeze, longus colli, splenius capitis).\n\nNeck Disability Index will be filled in order to evaluate activities of daily life. Symptom duration and pain level will be evaluated by VAS.\n\nTangent and Cobb angles will be measured on cervical X-RAY images. Presence of effective lordosis will be recorded.\n\nIn cervical MR, disc herniation level, number, degree (bulging, protrusion, extruded disc) its level will be recorded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '125 Patients with chronic neck pain aged between 18-65 who have their Cervical X-RAY and MRIs being taken within the last 3 months in regards to the inclusion and exclusion criterias.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-65 years old\n* Axial neck pain and / or upper extremity radicular symptoms\n* Existing MR and X-Ray radiographs taken within the last 3 months for cervical disc pathologies\n\nExclusion Criteria:\n\n* A history of trauma,\n* Patients with rheumatoid / autoimmune diseases such as rheumatoid arthritis or ankylosing spondylitis,\n* A history of Cervical fracture or cervical spine surgery\n* History of cancer history, neurological disease\n* Muscle weakness\n* Presence of Scoliosis'}, 'identificationModule': {'nctId': 'NCT04886661', 'briefTitle': 'Correlation of Cervical Lordosis Degree Detected on Cervical X-Ray Image With Clinical, Demographic and MRI Findings', 'organization': {'class': 'OTHER', 'fullName': 'Haydarpasa Numune Training and Research Hospital'}, 'officialTitle': 'Correlation of Cervical Lordosis Detected on Cervical X-Ray Images With Clinical, Demographic and MRI Findings', 'orgStudyIdInfo': {'id': 'HNEAH-KAEK 2021/22'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'PATIENTS WITH CHRONIC NECK PAIN', 'description': 'Patients between the ages of 18-65 who are eligible for the inclusion criteria will be included in the study who have cervical X-RAY and cervical MRIs taken in the last 3 months.', 'interventionNames': ['Other: CHRONIC NECK PAIN']}], 'interventions': [{'name': 'CHRONIC NECK PAIN', 'type': 'OTHER', 'description': 'Demographic information will be collected. Neck Disability Index will be filled. Physical examination will be performed.', 'armGroupLabels': ['PATIENTS WITH CHRONIC NECK PAIN']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Duygu Külcü, Prof.', 'role': 'CONTACT', 'email': 'd_geler@yahoo.com.tr', 'phone': '00905058575178'}, {'name': 'Ozlem Kaleoglu, MD', 'role': 'CONTACT', 'email': 'ozlemkaleoglu@gmail.com', 'phone': '00905321598018'}, {'name': 'Özlem Kaleoğlu, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Dilara Dilik, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Elem Yorulmaz, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Nilgün Mesci, Ass Prof.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Elif Çiğdem Altunok, Ass Prof.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Haydarpaşa Numune Education and Research Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Haydarpasa Numune Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, M.D.', 'investigatorFullName': 'Duygu Geler Külcü', 'investigatorAffiliation': 'Haydarpasa Numune Training and Research Hospital'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2022-08-04', 'type': 'RELEASE'}, {'date': '2023-07-05', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Duygu Geler Külcü, Professor, M.D., Haydarpasa Numune Training and Research Hospital'}}}}