Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-26 @ 12:35 AM
Study NCT ID:
NCT06745960
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-12-24
First Post:
2024-12-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Electrical Stimulation on Forward Head Posture
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-18', 'studyFirstSubmitDate': '2024-12-09', 'studyFirstSubmitQcDate': '2024-12-18', 'lastUpdatePostDateStruct': {'date': '2024-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'shoulder angle (SA)', 'timeFrame': 'From enrollment to the end of treatment at 8 weeks', 'description': 'To measure Shoulder Angle (SA) of rounded shoulder, a line from anterolateral aspect of acromion to C7 will be taken and a horizontal line from anterolateral aspect of acromion , it will be considered as forward shoulder when the angle is 52 degree or less.'}, {'measure': 'craniovertebral angle (CVA)', 'timeFrame': 'From enrollment to the end of treatment at 8 weeks', 'description': 'To measure Craniovertebral Angle (CVA) of forward head posture, a line from C7 to tragus of the ear will be taken and a horizontal line from C7 (the normal CVA more than 50 degree).'}, {'measure': 'head tilt angle (HTA)', 'timeFrame': 'From enrollment to the end of treatment at 8 weeks', 'description': 'To measure head tilt angle (HTA) or cranial angle (CA) the angle of the line between the canthus of the eye and horizontal line from the tragus, the head tilt angles is 17.74 ± 4.9 degrees in people with normal head posture.'}, {'measure': 'head position angle (HPA)', 'timeFrame': 'From enrollment to the end of treatment at 8 weeks', 'description': 'To measure head position angle (HPA) angle between the tragus manubrium line and the line extending from the center point of chin to the tragus, the angle is 38.1 ± 4.9 degrees in people with normal head posture.'}], 'secondaryOutcomes': [{'measure': 'Pain sensation', 'timeFrame': 'From enrollment to the end of treatment at 8 weeks', 'description': 'pain will be measured by visual analogue scale (VAS) , it is a numeric scale where 0 means no pain and 10 mean maximum pain.'}, {'measure': 'cervical range of motion', 'timeFrame': 'From enrollment to the end of treatment at 8 weeks', 'description': 'cervical rang of motion will be measured by goniometer, where the normal angles for each movement are Flexion 60 degree , Hyperextension 75 degree, Lateral Flexion 45 degree, Rotation 80 degree.'}, {'measure': 'neck muscles strength', 'timeFrame': 'From enrollment to the end of treatment at 8 weeks', 'description': 'neck muscles strength will be measured by hand held dynamometer, strength is measured in units of force per unit area. The unit is kilogram (force) per square cm (kg/cm\\^2)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['electrical stimulation', 'interferential current', 'adolescence'], 'conditions': ['Forward Head Posture', 'Rounded Shoulder Posture']}, 'referencesModule': {'references': [{'pmid': '38780139', 'type': 'BACKGROUND', 'citation': 'Elgendy MH, Ghaffar MAA, Sabbahi SAE, Abutaleb EES, Elsayed SEB. Efficacy of head postural correction program on craniovertebral angle, scapular position, and dominant hand grip strength in forward head posture subjects: A randomized controlled trial. Physiother Res Int. 2024 Jul;29(3):e2093. doi: 10.1002/pri.2093.'}, {'pmid': '35172275', 'type': 'BACKGROUND', 'citation': 'Titcomb DA, Melton BF, Miyashita T, Bland HW. Evidence-Based Corrective Exercise Intervention for Forward Head Posture in Adolescents and Young Adults Without Musculoskeletal Pathology: A Critically Appraised Topic. J Sport Rehabil. 2022 Feb 16;31(5):640-644. doi: 10.1123/jsr.2021-0381. Print 2022 Jul 1.'}], 'seeAlsoLinks': [{'url': 'https://www.medicalnewstoday.com/articles/electrical-muscle-stimulation', 'label': 'effect of electrical muscle stimulation'}, {'url': 'https://images.app.goo.gl/TZyc6FqfEX1GASDm8', 'label': 'image of angles needed to be measured in this study'}]}, 'descriptionModule': {'briefSummary': 'The study aims are:\n\n1. To investigate the effect of electrical stimulation (interferential current) on forward head posture and protracted shoulder in adolescents.\n2. To investigate the effect of electrical stimulation on cervical pain, cervical ROM, neck muscle strength, and quality of life in adolescents with forward head posture and protracted shoulder.', 'detailedDescription': "Forward head posture (FHP) is commonly defined as the protrusion of the head in the sagittal plane so that the head is placed anterior to the trunk. It can occur because of anterior translation of the head, and it is claimed to be associated with an increase in upper cervical extension, lower cervical flexion, or both.\n\nPatients with FHP often experience neck pain and disability, it is associated with shortening of the upper trapezius, the posterior cervical extensor muscles, the sternocleidomastoid muscle, and levator scapulae muscle. Thus, FHP may contribute to neck and shoulder pain.\n\nThe prolonged uses of mobile phones and computers have led to a variety of musculoskeletal disorders, especially related to the neck as: Forward Head Posture (FHP), rounded shoulders (RS), upper cross syndrome, mechanical neck pain etc. FHP is one in which the upper cervical convexity is increased and the lower cervical convexity is decreased causing anterior weight bearing of the cervical spine. It is also known as Scholar's neck or Reading neck.\n\nElectrical muscle stimulation (EMS) has been used as a complementary training method, applied either locally or to the whole body. It activates muscles artificially through various electrical current forms, which are delivered through electrodes on the target muscles.\n\nInterferential current (IFC) is an established therapy which is used to treat pain and also effective for providing relaxation of muscles. The application of IFC at the medium frequency which suggests higher penetration of the electrical stimulation in the tissue by reducing tissue impedance"}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Girls aged between (15-18) years old.\n* Normal weight with BMI ranging from (16-25).\n* Adolescents with mild and moderate forward head posture(FHP).\n* Adolescents with mild and moderate neck pain.\n* Adolescents with protracted shoulder.\n\nExclusion Criteria:\n\n* Cervical disc.\n* Previous Shoulder trauma within last 6months.\n* Shoulder surgery.\n* Cervical fracture.\n* Congenital posture deformity.\n* Inflammatory disease, spinal tumor, spinal compression, spinal cord infection.\n* Taking any medication for pain'}, 'identificationModule': {'nctId': 'NCT06745960', 'briefTitle': 'Effect of Electrical Stimulation on Forward Head Posture', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Effect of Electrical Stimulation on Painful Forward Head and Protracted Shoulder Posture in Adolescents', 'orgStudyIdInfo': {'id': 'forward head posture'}, 'secondaryIdInfos': [{'id': 'P.T.REC/012/005173', 'type': 'REGISTRY', 'domain': 'research ethical committee'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'intervention group', 'description': 'study group (interferential current )', 'interventionNames': ['Device: electrical muscle stimulation device (EMS gymna)', 'Other: physical therapy program']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'physical therapy exercises group', 'description': 'control group (exercise group)', 'interventionNames': ['Other: physical therapy program']}], 'interventions': [{'name': 'electrical muscle stimulation device (EMS gymna)', 'type': 'DEVICE', 'description': 'muscle stimulant device', 'armGroupLabels': ['intervention group']}, {'name': 'physical therapy program', 'type': 'OTHER', 'description': 'neck exercises', 'armGroupLabels': ['intervention group', 'physical therapy exercises group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Dokki', 'state': 'Giza Governorate', 'country': 'Egypt', 'contacts': [{'name': 'faculty of physical therapy CU Cairo university', 'role': 'CONTACT', 'email': 'info@pt.cu.edu.eg', 'phone': '+2037617691'}], 'facility': 'Faculty of Physical Therapy', 'geoPoint': {'lat': 30.03823, 'lon': 31.2113}}], 'centralContacts': [{'name': 'yosra MM Ali', 'role': 'CONTACT', 'email': 'yosra.mostafa27@gmail.com', 'phone': '+201013697310', 'phoneExt': '+201285604994'}, {'name': 'Eman I Alhadidy', 'role': 'CONTACT', 'email': 'emanalhadedy@gmail.com', 'phone': '+201223375282', 'phoneExt': '+201001457239'}], 'overallOfficials': [{'name': 'asmaa O SAYED', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cairo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant lecturer', 'investigatorFullName': 'yosra mostafa mohamed ali', 'investigatorAffiliation': 'Cairo University'}}}}