Ignite Creation Date:
2025-12-24 @ 3:35 PM
Ignite Modification Date:
2026-01-05 @ 5:49 PM
Study NCT ID:
NCT06491992
Status:
RECRUITING
Last Update Posted:
2024-07-09
First Post:
2024-07-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chitosan Phonophresis on Cervical IN Smartphone Addicted Users
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-10-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-01', 'studyFirstSubmitDate': '2024-07-01', 'studyFirstSubmitQcDate': '2024-07-01', 'lastUpdatePostDateStruct': {'date': '2024-07-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Smartphone Addiction Scale-Short Version (SAS-SV)', 'timeFrame': 'four weeks', 'description': 'SAS-SV was psychometrically robust in measuring the severity of smartphone addiction'}, {'measure': 'The visual analogue scale', 'timeFrame': 'four weeks', 'description': 'was utilized to evaluate pre- and post-treatment neck pain'}, {'measure': 'Neck disability index', 'timeFrame': 'four weeks', 'description': "assess how neck pain and other symptoms manifested during various functional activities. Ndi had been reported as a reliable (Cronbach's alpha: 0.89) and valid instrument to evaluate self-rated disability in patients with neck pain"}], 'secondaryOutcomes': [{'measure': 'Cervical ROM', 'timeFrame': 'four weeks', 'description': 'Cervical active ROM will be measured for each participant in the study by digital goniometer device.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cervical Pain']}, 'descriptionModule': {'briefSummary': 'A phonophoresis-based drug delivery system is a synchronous approach to improve local drug penetration in neuromuscular diseases associated with neuronal damage, excruciating pain, and local inflammation. Chitosan, a semi-synthetic material, is obtained by partial deacetylation of chitin amines, resulting in copolymers of N-acetylglucosamine and N-glucosamine. Its use has been explored in various biomaterial and medical applications. Chitosan has emerged as a cost-effective, biocompatible, and biodegradable material with many desirable biological properties, improvement of homeostasis and antiviral potential. Chitosan was found to suppress pro-inflammatory cytokines and decreased peripheral nerve edema, the polycationic nature of chitosan allows it to absorb protons, which reduces inflammation and provides an analgesic effect.', 'detailedDescription': 'The patients will randomly be divided into two equal groups; the control group which will receive the selected exercise program and the study group will receive the same exercise training program in addition to Chitosan Phonophresis, three times per week for four weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Their age will be ranged from 16-18 years\n* body mass index will be 26.58 kg/m2.\n* used a smart phone for more than 1 year for at least 2 hours per day\n* complaining of neck pain after using a smart phone, addiction to smart phone in accordance with the smart phone addiction scale (SAS)\n\nExclusion Criteria:\n\n* any previous head and neck injuries or surgeries\n* any congenital abnormalities or symptomatic deformity in either the cervical or the lumbar spine\n* any uncorrected visual or auditory problems, dizziness, vertigo and headache\n* any systematic diseases, any addiction to alcohol, any additive drugs and sedatives within 48 hours previous to tests\n* body mass index of subjects over25 kg/m2.'}, 'identificationModule': {'nctId': 'NCT06491992', 'briefTitle': 'Chitosan Phonophresis on Cervical IN Smartphone Addicted Users', 'organization': {'class': 'OTHER', 'fullName': 'October 6 University'}, 'officialTitle': 'Effect of Chitosan Phonophresis on Cervical Pain and Disability in Smartphone Addicted Users', 'orgStudyIdInfo': {'id': 'O6U.PT.REC/024/002003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'study group', 'description': 'Chitosan Phonophresis intervention', 'interventionNames': ['Drug: Chitosan Phonophresis', 'Other: selected physical therapy exercise']}, {'type': 'EXPERIMENTAL', 'label': 'control group', 'description': 'the selected exercise program', 'interventionNames': ['Other: selected physical therapy exercise']}], 'interventions': [{'name': 'Chitosan Phonophresis', 'type': 'DRUG', 'description': 'Chitosan Phonophresis, three times per week for four weeks.', 'armGroupLabels': ['study group']}, {'name': 'selected physical therapy exercise', 'type': 'OTHER', 'description': 'selected neck exercise and electrotherapy on cervical region', 'armGroupLabels': ['control group', 'study group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Al Jīzah', 'state': 'Select State', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Lama S Mahmoud', 'role': 'CONTACT', 'email': 'lamaelsedawyy@hotmail.com', 'phone': '01157592636'}], 'facility': 'Lama S Mahmoud', 'geoPoint': {'lat': 31.15035, 'lon': 30.19636}}], 'centralContacts': [{'name': 'Lama Saad El-Din ED Mahmoud', 'role': 'CONTACT', 'email': 'lamaelsedawyy@hotmail.com', 'phone': '01157592636'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'October 6 University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lama Saad El-Din Mahmoud', 'investigatorFullName': 'Lama Saad El-Din Mahmoud', 'investigatorAffiliation': 'October 6 University'}}}}