Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2025-12-27 @ 4:34 AM
Study NCT ID:
NCT04051593
Status:
COMPLETED
Last Update Posted:
2023-09-21
First Post:
2019-08-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Cervical Stabilization Exercise in Violinists With Chronic Neck Pain
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'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-04-18', 'size': 537020, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-08-07T08:53', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2018-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-19', 'studyFirstSubmitDate': '2019-08-03', 'studyFirstSubmitQcDate': '2019-08-08', 'lastUpdatePostDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in self-reported neck pain: Numeric Rating Scale', 'timeFrame': 'Pre-test 1 (week 0), Pre-test 2 (week 4) and Post-test (week 10)', 'description': 'Measured by the Numeric Rating Scale (min 0-max 10, better outcome 0 worst outcome 10)'}, {'measure': 'Changes in neck disability', 'timeFrame': 'Pre-test 1 (week 0), Pre-test 2 (week 4) and Post-test (week 10)', 'description': 'Measured by the Neck Disability Index (10-item questionnaire, each item scored from 0 to 5, result expressed as percentage, better outcome 0 worst outcome 100%)'}], 'secondaryOutcomes': [{'measure': 'Changes in deep neck flexors function', 'timeFrame': 'Pre-test 1 (week 0), Pre-test 2 (week 4) and Post-test (week 10)', 'description': 'Measured by the craniocervical flexion test with a pressure biofeedback unit (higher pressure represents better outcome)'}, {'measure': 'Changes in cervical muscle endurance', 'timeFrame': 'Pre-test 1 (week 0), Pre-test 2 (week 4) and Post-test (week 10)', 'description': 'Measured using a stopwatch for the successful time holding the head in cervical flexion and extension positions (longer time represent better outcome)'}, {'measure': 'Changes in cervical joint position sense', 'timeFrame': 'Pre-test 1 (week 0), Pre-test 2 (week 4) and Post-test (week 10)', 'description': 'Measured by the cervcal joint reposition error with a laser pointer (short distance represent better outcome)'}, {'measure': 'Changes in upper body posture', 'timeFrame': 'Pre-test 1 (week 0), Pre-test 2 (week 4) and Post-test (week 10)', 'description': 'Evaluated by the photographic method'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cervical stabilization exercise'], 'conditions': ['Neck Pain']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine the influence of a 6-week cervical stabilization exercise program in university violin players with chronic nonspecific neck pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '25 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* duration of playing the instrument longer than 5 years\n* practicing the violin more than 5 hours/week\n* constant neck pain for more than 3 months or at least 2 pain episodes in the last 3 months\n\nExclusion Criteria:\n\n* previous surgery in the neck and shoulder regions\n* current participation in a structured exercises program\n* current treatment for neck and shoulder pain\n* red flags suggesting of cancer, infection, vascular insufficiency, and etc. during history taking\n* neurological symptoms of the upper extremities during screening tests (e.g. Spurling test and upper limb tension tests)'}, 'identificationModule': {'nctId': 'NCT04051593', 'briefTitle': 'Effects of Cervical Stabilization Exercise in Violinists With Chronic Neck Pain', 'organization': {'class': 'OTHER', 'fullName': 'National Cheng Kung University'}, 'officialTitle': 'Cervical Stabilization Exercises Improved Pain, Disability, and Physical Impairments in University Violinists With Nonspecific Neck Pain', 'orgStudyIdInfo': {'id': 'NationalCheng-KungU'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'Exercise', 'interventionNames': ['Other: Cervical stabilization exercise']}], 'interventions': [{'name': 'Cervical stabilization exercise', 'type': 'OTHER', 'description': 'The participants followed instructional videos and performed the cervical stabilization exercise program at home for 20 minutes/day, 3 days/week, for 6 weeks.', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '701', 'city': 'Tainan', 'country': 'Taiwan', 'facility': 'National Cheng Kung University', 'geoPoint': {'lat': 22.99083, 'lon': 120.21333}}], 'overallOfficials': [{'name': 'Yi-Ju Tsai, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Cheng Kung University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cheng Kung University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'YI-JU TSAI', 'investigatorAffiliation': 'National Cheng Kung University'}}}}