Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-27 @ 10:48 PM
Study NCT ID:
NCT04703660
Status:
UNKNOWN
Last Update Posted:
2021-05-11
First Post:
2021-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Cervical Mobilization on Rotator Cuff Tendinitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070636', 'term': 'Rotator Cuff Injuries'}], 'ancestors': [{'id': 'D012421', 'term': 'Rupture'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D000070599', 'term': 'Shoulder Injuries'}, {'id': 'D013708', 'term': 'Tendon Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2021-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-05-09', 'studyFirstSubmitDate': '2021-01-07', 'studyFirstSubmitQcDate': '2021-01-08', 'lastUpdatePostDateStruct': {'date': '2021-05-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in strength of shoulder abductors', 'timeFrame': 'before treatment, immediate, 10 minutes, and 30 minutes after cervical mobilization', 'description': 'strength testing with a hand-held dynamometer will be applied for 3 groups using Isometric contraction of shoulder abductors'}, {'measure': 'change in strength of shoulder external rotators', 'timeFrame': 'before treatment, immediate, 10 minutes, and 30 minutes after cervical mobilization', 'description': 'strength testing with a hand-held dynamometer will be applied for 3 groups using Isometric contraction of shoulder external rotators'}, {'measure': 'change in pain level', 'timeFrame': 'before treatment, immediate, 10 minutes, and 30 minutes after cervical mobilization', 'description': 'pain severity will be measured using visual analogue scale for 3 groups'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rotator Cuff Tendinitis']}, 'descriptionModule': {'briefSummary': 'this study aimed to investigate the effect of 3 types of cervical mobilization on the strength of shoulder abductors, external rotators and pain level in patient with rotator cuff tendinitis. the measurement will be made immediately, 10 minutes, and 30 minutes after mobilization', 'detailedDescription': 'subjects will be allocated according to the inclusion and exclusion criteria from outpatient clinic at El sahel teaching hospital. they will be assigned randomly into 3 groups, each group will receive certain type of cervical mobilization. the outcome measures will be measured before, immediate, 10 minutes, and 30 minutes after treatment'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients will be included if they have rotator cuff tendinitis\n\nExclusion Criteria:\n\n* Patients will be excluded if they had recent neck trauma or acute whiplash disorder ,any intra articular injection in the gleno-humeral joint during last three months, patients with musculoskeletal disorder (any type of fracture), any history of surgery on that shoulder and tendon calcification, cervical rib, rotator cuff tear.'}, 'identificationModule': {'nctId': 'NCT04703660', 'briefTitle': 'Effect of Cervical Mobilization on Rotator Cuff Tendinitis', 'organization': {'class': 'OTHER', 'fullName': 'Egyptian Chinese University'}, 'officialTitle': 'Immediate and Carry Over Effect of Different Cervical Mobilization Techniques on Rotator Cuff Tendinitis Patients', 'orgStudyIdInfo': {'id': 'interventional'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'group A', 'description': 'This group will receive antero-posterior cervical mobilization at c5-6 grade III oscillation', 'interventionNames': ['Procedure: cervical mobilization']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'group B', 'description': 'This group will receive lateral glide cervical mobilization at c5-6 grade III oscillation', 'interventionNames': ['Procedure: cervical mobilization']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'group C', 'description': 'This group will receive postero-anterior cervical mobilization at c5-6 grade III oscillation', 'interventionNames': ['Procedure: cervical mobilization']}], 'interventions': [{'name': 'cervical mobilization', 'type': 'PROCEDURE', 'description': '3 types of cervical mobilization at the level of C 5- 6', 'armGroupLabels': ['group A', 'group B', 'group C']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Noha S Elserty, PhD', 'role': 'CONTACT'}], 'facility': 'Noha Elserty', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Noha S Elserty, PhD', 'role': 'CONTACT', 'email': 'noha_elserty@hotmail.com', 'phone': '+201006709648'}, {'name': 'Rania R Mohamed, PhD', 'role': 'CONTACT', 'email': 'raniareda22@Hotmail.com', 'phone': '+201273325285'}], 'overallOfficials': [{'name': 'Noha S Elserty, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lecturer of physical therapy- Egyptian Chinese University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'after publishing the study', 'ipdSharing': 'YES', 'description': 'supporting information that will be shared after publication of the study'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Noha Elserty', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'lecturer of physical therapy', 'investigatorFullName': 'Noha Elserty', 'investigatorAffiliation': 'Egyptian Chinese University'}}}}