Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2026-03-02 @ 3:58 PM
Study NCT ID:
NCT03757520
Status:
COMPLETED
Last Update Posted:
2020-11-10
First Post:
2018-11-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Text Neck Syndrome and Hand Grip Force in Smart Phone Addiction Among Students of Jazan University
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D019547', 'term': 'Neck Pain'}, {'id': 'D013180', 'term': 'Sprains and Strains'}, {'id': 'D009209', 'term': 'Myofascial Pain Syndromes'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'FACTORIAL', 'interventionModelDescription': 'According two Smartphone Addiction Proneness Scale (SAPS) the subjects will be divided into two groups: Regular user group with SAPS score 39 or less. Heavy user group with SAPS score 40 or more.\n\nwe have two variables to be assessed:\n\n1. Pain pressure threshold for two muscles (upper fiber of trapezius and sternocleidomastoid muscle)\n2. Hand grip force'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 600}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-08-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2020-10-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-07', 'studyFirstSubmitDate': '2018-11-23', 'studyFirstSubmitQcDate': '2018-11-27', 'lastUpdatePostDateStruct': {'date': '2020-11-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain pressure threshold for upper fiber of trapezius muscle', 'timeFrame': '3 minutes', 'description': 'Using Algometer to measure pain pressure for upper trapezius trigger point which lies in the more horizontal fibers of the upper trapezius on the back of the shoulder, about halfway between spine and the acromion on right and left side for 3 repetition for each'}, {'measure': 'Pain pressure threshold for sternocleidomastoid muscle', 'timeFrame': '9 minutes', 'description': 'Using Algometer to measure pain pressure for sternocleidomastoid muscle on right and left side for 3 repetition for each. Measurement will includes three sites on each side:\n\n1\\. upper part of the sternal division of the muscle near to its insertion into the mastoid process. 2. he mid-part of the sternal division of the muscle. 3. lower end of this division near to its attachment to the sternum.'}, {'measure': 'Hand Grip Force', 'timeFrame': '15 minutes', 'description': 'For measuring the grip strength, the subjects will be asked to sit on a chair with their hip joint flexed at 90 degree, and shoulder joint in a neutral position.\n\nThe elbow is fixed at 90 degree flexion, forearm in a neutral position, and wrist at 0 to 15 degree radial deviation.The test will be performed twice, and the higher value between the two measurements will be selected.\n\nThe subjects are allowed a rest time of more than 5 minutes after the first measurement to avoid examiner bias and to decrease physical stress'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain, Back', 'Neck Pain', 'Postural; Strain', 'Myofascial Pain Syndrome']}, 'descriptionModule': {'briefSummary': 'This study will be conducted in the Department of physical therapy, College of Applied Medical Sciences,Jazan University, to investigate text neck syndrome and hand grip force in smart phone addiction among students of jazan university', 'detailedDescription': 'Four hundreds students with age 19 to 26 years old, and right dominant hand, will be recruited from the College of Applied Medical Sciences, Jazan University. Subjects will be randomly assigned to into a heavy user group (n=300; female and male students) and a control or regular use group (n=300; female and male students) according to their smartphone addiction proneness scale.\n\nBaseline hydraulic hand dynamometer: (Fabrication Enterprises Incorporated, White Plains,New York, USA) is used to measure the hand grip strength and pinch strength.\n\nAlgometer Commander (JTech Medical Company) is used on the location of the trigger point to assess the amount of pressure the patient could sustain before the patient registered the pressure as being painful for upper fiber of trapezius muscle and sternocleidomastoid muscle'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '26 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. The participant will be right-handed.\n2. No abnormal findings confirmed through physical and neurological examination.\n3. No congenital abnormalities in either the cervical or the lumbar spine.\n4. No history of severe surgical procedures ( Park et al., 2015) .\n\nExclusion Criteria:\n\n1. History of a neurological disease.\n2. History of musculoskeletal injury of neck and lumbar region.\n3. Unstable medical condition.'}, 'identificationModule': {'nctId': 'NCT03757520', 'briefTitle': 'Evaluation of Text Neck Syndrome and Hand Grip Force in Smart Phone Addiction Among Students of Jazan University', 'organization': {'class': 'OTHER_GOV', 'fullName': 'University of Jazan'}, 'officialTitle': 'Evaluation of Text Neck Syndrome and Hand Grip Force in Smart Phone Addiction Among Students of Jazan University', 'orgStudyIdInfo': {'id': '0018827704'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Regular user group', 'description': 'Their number: 300; female and male students, will earn 39 points or less of Smartphone Addiction Proneness Scale. Pain Pressure Threshold and Hand Grip Force will Measured for them.', 'interventionNames': ['Diagnostic Test: Pain Pressure Threshold', 'Diagnostic Test: Hand Grip Force']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Heavy user group', 'description': 'Their number: 300; female and male students, will earn 40 points or more of Smartphone Addiction Proneness Scale. Pain Pressure Threshold and Hand Grip Force will Measured for them.', 'interventionNames': ['Diagnostic Test: Pain Pressure Threshold', 'Diagnostic Test: Hand Grip Force']}], 'interventions': [{'name': 'Pain Pressure Threshold', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['PPTs'], 'description': 'The pain pressure thresholds (PPTs) will be measured using an pressure algometer commander over potential trigger points (TrPs) on the body for upper fiber of trapezius, and sternocleidomastoid muscle.', 'armGroupLabels': ['Heavy user group', 'Regular user group']}, {'name': 'Hand Grip Force', 'type': 'DIAGNOSTIC_TEST', 'description': 'For measuring the grip strength, the subjects will be asked to sit on a chair with their hip joint flexed at 90 degree, and shoulder joint in a neutral position.\n\nThe elbow is fixed at 90 degree flexion, forearm in a neutral position, and wrist at 0 to 15 degree radial deviation The test will be performed twice, and the higher value between the two measurements will be selected.', 'armGroupLabels': ['Heavy user group', 'Regular user group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45142', 'city': 'Riyadh', 'state': 'Jazan Region', 'country': 'Saudi Arabia', 'facility': 'Jazan University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'there is no plan'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wafaa Mahmoud Amin', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Wafaa Mahmoud Amin', 'investigatorAffiliation': 'University of Jazan'}}}}