Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 10:39 PM
Study NCT ID:
NCT07148167
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-29
First Post:
2025-07-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Cervical Extensor Muscle Thickness, Fat Infiltration, and Cervical Alignment in Patients With Ankylosing Spondylitis With a Healthy Population: a Retrospective Controlled Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D009682', 'term': 'Magnetic Resonance Spectroscopy'}], 'ancestors': [{'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}, 'targetDuration': '1 Month', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-22', 'studyFirstSubmitDate': '2025-07-14', 'studyFirstSubmitQcDate': '2025-08-22', 'lastUpdatePostDateStruct': {'date': '2025-08-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'servical MRI fındings in AS patients,', 'timeFrame': 'Patients who underwent cervical MRI between January 2020 and September 2023', 'description': 'the cervical muscle planes, cervical muscle volumes in AS patients cervical fat infiltration'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Muscle Planes, Muscle Volumes, Fat Infiltration in Cervical MRI']}, 'descriptionModule': {'briefSummary': "In the literature, we found only one study evaluating the thickness of the cervical paraspinal muscles (multifidus, semispinalis cervicis, semispinalis capitis, splenius capitis, and trapezius) in patients with AS. This study examined the morphology of all neck extensor muscles (multifidus, semispinalis capitis, semispinalis cervicis, splenius capitis, and trapezius muscles) using ultrasound and their relationship to activities of daily living and compared them with a control group. As is well known, the user's experience is crucial in ultrasound. Furthermore, ultrasound cannot accurately assess the deep paravertebral muscles. Therefore, inspired by this study, we decided to use Magnetic Resonance Imaging (MRI) to evaluate the cervical muscle planes in AS patients in more detailed and objective ways. In this study, in addition to cervical muscle volumes in AS patients, we also aimed to evaluate cervical fat infiltration and cervical alignment, which have not been previously evaluated in AS patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'For the study group:\n\n* Patients diagnosed with ankylosing spondylitis, aged 18-50.\n* Patients who underwent a cervical MRI between January 2020 and September 2023. Control Group Patients aged 18-50 who underwent cervical MRI between January 2020 and September 2023 due to nonspecific neck pain, who did not have an AS diagnosis and whose cervical MRI was reported as normal.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* For the study group:\n* Patients diagnosed with ankylosing spondylitis, aged 18-50.\n* Patients who underwent a cervical MRI between January 2020 and September 2023. Control Group Patients aged 18-50 who underwent cervical MRI between January 2020 and September 2023 due to nonspecific neck pain, who did not have an AS diagnosis and whose cervical MRI was reported as normal.\n\nExclusion Criteria:\n\n* Patients over 50 years of age\n* History of spine surgery;\n* Presence of pain, numbness, and weakness in the upper extremities\n* History of cervical injury or neck injury\n* Presence of tuberculosis, tumor, fracture, infection, instability, cervical myelopathy, cervical disc herniation (protrusion, extrusion) (will be considered cervical bulging)\n* Presence of cervical radiculopathy\n* Those with a detectable pathological spinal condition related to neck pain, including spinal deformity; inflammatory or rheumatic diseases other than AS, malignancies, or neurological diseases\n* A cognitive or psychological disorder'}, 'identificationModule': {'nctId': 'NCT07148167', 'briefTitle': 'Comparison of Cervical Extensor Muscle Thickness, Fat Infiltration, and Cervical Alignment in Patients With Ankylosing Spondylitis With a Healthy Population: a Retrospective Controlled Study', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Kayseri City Hospital'}, 'officialTitle': 'Cervical MRI Findings in Patients With Ankylosing Spondylitis', 'orgStudyIdInfo': {'id': 'Kayseri City EAH'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Ankylosing Spondylitis group', 'description': 'For the study group:\n\n* Patients diagnosed with ankylosing spondylitis, aged 18-50.\n* Patients who underwent a cervical MRI between January 2020 and September 2023.', 'interventionNames': ['Other: Magnetic resonance imaging']}, {'label': 'Control Group', 'description': 'Patients aged 18-50 who underwent cervical MRI between January 2020 and September 2023 due to nonspecific neck pain, who did not have an AS diagnosis and whose cervical MRI was reported as normal.', 'interventionNames': ['Other: Magnetic resonance imaging']}], 'interventions': [{'name': 'Magnetic resonance imaging', 'type': 'OTHER', 'description': 'use Magnetic Resonance Imaging (MRI) to evaluate the cervical muscle planes in AS patients in more detailed and objective ways. In this study, in addition to cervical muscle volumes in AS patients, we also aimed to evaluate cervical fat infiltration and cervical alignment, which have not been previously evaluated in AS patients.', 'armGroupLabels': ['Ankylosing Spondylitis group', 'Control Group']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kayseri City Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor', 'investigatorFullName': 'Ayse Guc', 'investigatorAffiliation': 'Kayseri City Hospital'}}}}