Ignite Creation Date:
2025-12-24 @ 5:03 PM
Ignite Modification Date:
2026-01-06 @ 5:40 AM
Study NCT ID:
NCT05185050
Status:
COMPLETED
Last Update Posted:
2022-06-27
First Post:
2021-12-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevalence of Myofascial Pain Syndrome in Adolescent Idiopathic Scoliosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012600', 'term': 'Scoliosis'}, {'id': 'D009209', 'term': 'Myofascial Pain Syndromes'}], 'ancestors': [{'id': 'D013121', 'term': 'Spinal Curvatures'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009135', 'term': 'Muscular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010808', 'term': 'Physical Examination'}], 'ancestors': [{'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 168}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2022-04-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-22', 'studyFirstSubmitDate': '2021-12-23', 'studyFirstSubmitQcDate': '2021-12-23', 'lastUpdatePostDateStruct': {'date': '2022-06-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cobb angle', 'timeFrame': '1 day', 'description': 'The Cobb angle is the most widely used measurement to quantify the magnitude of spinal deformities, especially in the case of scoliosis, on plain radiographs. Scoliosis is defined as a lateral spinal curvature with a Cobb angle of \\>10°'}, {'measure': 'The angle of cervical lordosis', 'timeFrame': '1 day', 'description': 'Cervical Lordosis refers to the natural curve of the spine in the neck, known as the cervical spine'}, {'measure': 'The angle of thoracic kyphosis', 'timeFrame': '1 day', 'description': 'thoracic Kyphosis is an abnormally excessive convex curvature of the spine as it occurs in the thoracic regions'}, {'measure': 'The angle of lumbar lordosis', 'timeFrame': '1 day', 'description': 'Lumbar lordosis is the inward curve of the lumbar, or lower, spine in the lower back'}, {'measure': 'Sagittal vertical axis', 'timeFrame': '1 day', 'description': 'he C7 plumb line is a radiographic reference to determine the sagittal vertical axis'}, {'measure': 'pelvic incidence', 'timeFrame': '1 day', 'description': 'Pelvic incidence is defined as the angle between a line perpendicular to the sacral plate at its midpoint and a line connecting this point to the femoral head axis.'}, {'measure': 'sacral slope', 'timeFrame': '1 day', 'description': 'Sacral slope isdefined as the angle between a sacral plate and the horizontal line. A vertical sacrum is described by a low sacral slope value and a horizontal sacrum by a high value sacral slope'}, {'measure': 'pelvic tilt', 'timeFrame': '1 day', 'description': 'Pelvic tilt is defined by a line through midpoint of the sacral plate and midpoint of the femoral head axes and the vertical line through the midpoint of the femoral head axis.'}, {'measure': 'VAS', 'timeFrame': '1day', 'description': 'Visual analog scale (The grade of pain)'}, {'measure': 'Myfascial pain syndrome', 'timeFrame': '1 day', 'description': 'Using by Myfascial pain syndrome diagnostic criteria'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['scoliosis', 'sagittal alignment', 'cobb angle', 'myofascial pain'], 'conditions': ['Scoliosis; Adolescence', 'Myofascial Pain Syndrome', 'Trigger Point Pain, Myofascial', 'Physical Medicine and Rehabilitation']}, 'descriptionModule': {'briefSummary': 'this is an observational and cross-sectional prevalence study. 10-18 years aged participants with adolescent idiopathic scoliosis were recruited in the study. Myofascial pain syndrome will be questioned to the participants. additionally, all participants will be evaluated using their findings for scoliosis and myofascial pain syndrome diagnostic criteria. Cobb angle, coronal balance, shoulder and pelvis asymmetry, sagittal spino-pelvic parameters of the spine (cervical lordosis, thoracic kyphosis, lumbar lordosis angles and sagittal vertical axis, sacral slop angle and pelvic incidence) will be measured.', 'detailedDescription': 'This is an observational and cross-sectional prevalence study. Patients diagnosed with adolescent idiopathic scoliosis who applied to the Physical Medicine and Rehabilitation Clinic of Kanuni Sultan Süleyman Training and Research Hospital will be included in our study. These participants will be aged between 10-18 years. These patients will be evaluated using their findings for scoliosis and myofascial pain syndrome diagnostic criteria. Cobb angle, coronal balance, shoulder and pelvis asymmetry, sagittal spino-pelvic parameters of the spine (cervical lordosis, thoracic kyphosis, lumbar lordosis angles and sagittal vertical axis, sacral slop angle and pelvic incidence) will be measured. Diagnostic criteria of Myofascial Pain Syndrome; As the Major Criteria;\n\n1. Regional pain complaint\n2. Pain or sensory change reflected from trigger points to a specific area 3. Palpable taut band in accessible muscles\n\n4\\. Extreme tenderness at one point along the taut band 5. Decreased range of motion that can be measured As for the Minor Criteria;\n\n1. Complaint of clinical pain and/or sensory change on pressurized palpation of the trigger point\n2. Local twitch response of the tender point on the taut band with palpation and needling 3. Reduction of pain by injection of the tender point or stretching of the muscle Five major and at least 1 minor criteria are required for the clinical diagnosis of myofascial pain syndrome.\n\nPatients with a previous history of surgery for scoliosis and neuromuscular scoliosis were excluded from the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '10 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Aged between 10-18 years with adolescent idiopathic scoliosis', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* aged between 10-18 years\n* diagnosed as adolescent idiopathic scoliosis\n* agreed to participate in the study\n\nExclusion Criteria:\n\n* neuromuscular or any other type of scoliosis\n* any surgical treatment for scoliosis or spine.'}, 'identificationModule': {'nctId': 'NCT05185050', 'briefTitle': 'Prevalence of Myofascial Pain Syndrome in Adolescent Idiopathic Scoliosis', 'organization': {'class': 'OTHER', 'fullName': 'Kanuni Sultan Suleyman Training and Research Hospital'}, 'officialTitle': 'Prevalence of Myofascial Pain Syndrome in Adolescent Idiopathic Scoliosis and the Relationship Between Myofascial Pain Syndrome and Spinal Coronal and Sagittal Alignment in Adolescent Idiopathic Scoliosis', 'orgStudyIdInfo': {'id': 'KAEK/2020.07.128'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'AIS with MPS', 'description': 'the participants who has Cobb angle above 10 degrees and diagnosed with myofascial pain syndrome', 'interventionNames': ['Diagnostic Test: physical examination and measurement of spinal alignment']}, {'label': 'AIS with no pain', 'description': 'the participants who has Cobb angle above 10 degrees and without pain', 'interventionNames': ['Diagnostic Test: physical examination and measurement of spinal alignment']}], 'interventions': [{'name': 'physical examination and measurement of spinal alignment', 'type': 'DIAGNOSTIC_TEST', 'description': 'physical examination for scoliosis and myofascial pain syndrome, measurement of spinal coronal and sagittal alignment in X-ray, and pain intensity (with Visual analog scale) if necessary (for MPS group)', 'armGroupLabels': ['AIS with MPS', 'AIS with no pain']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34303', 'city': 'Istanbul', 'state': 'Kucukcekmece', 'country': 'Turkey (Türkiye)', 'facility': 'Kanuni Sultan Süleyman Training and Research Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Merve Damla Korkmaz, 1', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kanuni Sultan Suleyman Training and Research Hospital'}]}, 'ipdSharingStatementModule': {'timeFrame': '1 day', 'ipdSharing': 'YES', 'description': 'Study Results will be shared after publication.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kanuni Sultan Suleyman Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Specialist Doctor', 'investigatorFullName': 'Merve Damla Korkmaz', 'investigatorAffiliation': 'Kanuni Sultan Suleyman Training and Research Hospital'}}}}