Ignite Creation Date:
2025-12-25 @ 1:21 AM
Ignite Modification Date:
2025-12-31 @ 4:10 PM
Study NCT ID:
NCT06903793
Status:
COMPLETED
Last Update Posted:
2025-09-03
First Post:
2025-03-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Cervical Manipulation on Cervical Rotation Motion and Shoulder Rotational Motion and Strength in Overhead Athletes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D020393', 'term': 'Manipulation, Spinal'}], 'ancestors': [{'id': 'D026201', 'term': 'Musculoskeletal Manipulations'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'the researchers performing the pre- and post-intervention measures will be blinded to the results of those measures'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-04-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-05-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-02', 'studyFirstSubmitDate': '2025-03-25', 'studyFirstSubmitQcDate': '2025-03-25', 'lastUpdatePostDateStruct': {'date': '2025-09-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cervical rotation active range of motion', 'timeFrame': 'from baseline to immediately post-intervention', 'description': 'Cervical rotation active ROM will be measured using the Cervical Range of Motion (CROM) device'}, {'measure': 'Shoulder Rotational range of motion', 'timeFrame': 'from baseline to immediately post-intervention', 'description': 'Dominant shoulder external rotation and internal rotation passive ROM at 90° of shoulder abduction will be measured using a digital inclinometer'}, {'measure': 'Shoulder Rotational strength', 'timeFrame': 'from baseline to immediately post-intervention', 'description': 'Dominant shoulder external rotation and internal rotation strength will be measured using the Hoggan MicroFET2 handheld dynamometer'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cervical manipulation', 'shoulder motion', 'shoulder strength', 'overhead athlete'], 'conditions': ['Cervical Spine', 'Manipulation, Spinal', 'Shoulder', 'Overhead Athlete']}, 'referencesModule': {'references': [{'pmid': '17273461', 'type': 'BACKGROUND', 'citation': 'Laudner KG, Stanek JM, Meister K. Assessing posterior shoulder contracture: the reliability and validity of measuring glenohumeral joint horizontal adduction. J Athl Train. 2006 Oct-Dec;41(4):375-80.'}, {'pmid': '29381423', 'type': 'BACKGROUND', 'citation': 'Keller RA, De Giacomo AF, Neumann JA, Limpisvasti O, Tibone JE. Glenohumeral Internal Rotation Deficit and Risk of Upper Extremity Injury in Overhead Athletes: A Meta-Analysis and Systematic Review. Sports Health. 2018 Mar/Apr;10(2):125-132. doi: 10.1177/1941738118756577. Epub 2018 Jan 30.'}, {'pmid': '39396612', 'type': 'BACKGROUND', 'citation': 'Bullock GS, Thigpen CA, Zhao H, Devaney L, Kline D, Noonan TJ, Kissenberth MJ, Shanley E. Neck range of motion prognostic factors in association with shoulder and elbow injuries in professional baseball pitchers. J Shoulder Elbow Surg. 2025 Feb;34(2):421-429. doi: 10.1016/j.jse.2024.08.026. Epub 2024 Oct 11.'}, {'pmid': '32523967', 'type': 'BACKGROUND', 'citation': 'Devaney LL, Denegar CR, Thigpen CA, Lepley AS, Edgar C, DiStefano LJ. Preseason Neck Mobility Is Associated With Throwing-Related Shoulder and Elbow Injuries, Pain, and Disability in College Baseball Pitchers. Orthop J Sports Med. 2020 May 18;8(5):2325967120920556. doi: 10.1177/2325967120920556. eCollection 2020 May.'}, {'pmid': '24726484', 'type': 'BACKGROUND', 'citation': 'Cools AM, De Wilde L, Van Tongel A, Ceyssens C, Ryckewaert R, Cambier DC. Measuring shoulder external and internal rotation strength and range of motion: comprehensive intra-rater and inter-rater reliability study of several testing protocols. J Shoulder Elbow Surg. 2014 Oct;23(10):1454-61. doi: 10.1016/j.jse.2014.01.006. Epub 2014 Apr 13.'}]}, 'descriptionModule': {'briefSummary': 'This study will examine the effects of a single session of a quick stretch technique delivered to the neck on neck and shoulder motion as well as shoulder strength in collegiate overhead athletes.', 'detailedDescription': 'Athletes participating in sports such as baseball, softball, tennis, swimming, and volleyball, are uniquely predisposed to cervical and shoulder dysfunction due to repetitive, high-intensity movements that require coordination between the cervical spine, shoulder, and upper extremities. These repetitive motions involve extreme glenohumeral (GH) range of motion (ROM) as well as high angular velocities, often leading to adaptations such as Glenohumeral Internal Rotation Deficit (GIRD). Overhead athletes with GIRD are at a higher risk of developing shoulder injuries.\n\nThis study aims to assess the effects of cervical spinal manipulation on cervical rotation ROM, GH rotational ROM and strength in overhead athletes. The current body of literature suggests an association between cervical rotation ROM deficits and arm injury risk in professional and collegiate-level baseball players. Restrictions in the cervical spine may alter neural and muscular pathways, potentially contributing to decreased shoulder ROM, compromised strength, and impaired performance. Given the complex interplay of cervical spine and shoulder function, understanding how cervical manipulation impacts the kinetic chain can play a vital role in developing shoulder rehabilitation and preventative programs for overhead athletes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years old and above\n* Current overhead college athlete\n* No mental health considerations such as generalized anxiety disorder, PTSD, and schizophrenia\n\nExclusion Criteria:\n\n* Upper extremity surgery in the last year\n* Current shoulder pain\n* Current neck pain\n* Recent episodes of vertigo, dizziness, and migraines\n* Recent motor vehicle accident\n* History of cardiovascular disease such as hypertension, heart attack, stroke, coronary artery disease, peripheral artery disease, arrhythmias, heart valve disease, congenital heart defects, and aortic aneurysm\n* Fear or unwillingness to undergo cervical manipulation'}, 'identificationModule': {'nctId': 'NCT06903793', 'briefTitle': 'Effects of Cervical Manipulation on Cervical Rotation Motion and Shoulder Rotational Motion and Strength in Overhead Athletes', 'organization': {'class': 'OTHER', 'fullName': 'Sacred Heart University'}, 'officialTitle': 'Effects of Cervical Manipulation on Cervical Rotation Range of Motion and Shoulder Rotational Range of Motion and Strength in Overhead Athletes', 'orgStudyIdInfo': {'id': 'IRB-FY2025-216'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cervical manipulation', 'description': 'All participants will be enrolled in the experimental group', 'interventionNames': ['Other: cervical manipulation']}], 'interventions': [{'name': 'cervical manipulation', 'type': 'OTHER', 'description': 'Cervical upglide/rotation manipulation targeted to C5/C6 on the dominant shoulder side', 'armGroupLabels': ['Cervical manipulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06825', 'city': 'Fairfield', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Sacred Heart University', 'geoPoint': {'lat': 41.14121, 'lon': -73.26373}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sacred Heart University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Jason Grimes, PT, PhD, OCS, ATC', 'investigatorAffiliation': 'Sacred Heart University'}}}}