Ignite Creation Date:
2025-12-25 @ 3:22 AM
Ignite Modification Date:
2025-12-26 @ 2:00 AM
Study NCT ID:
NCT07261605
Status:
COMPLETED
Last Update Posted:
2025-12-12
First Post:
2025-11-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical and Electromyographic Effect of Tui Na Massage Versus Positional Release on Postpartum Neck Dysfunction
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': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-01-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-09-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-04', 'studyFirstSubmitDate': '2025-11-22', 'studyFirstSubmitQcDate': '2025-11-22', 'lastUpdatePostDateStruct': {'date': '2025-12-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-05-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'visual analogue scale', 'timeFrame': '4 week', 'description': '10 cm horizontal line anchored by and it is a line score from zero to ten which 10 score means it is the worse of pain and zero score means the least pain ""no pain"" on the leftand ""worst imaginable pain"" on the right). Patients indicate their pain intensity by marking on the point at the line that reflect their pain'}, {'measure': 'Neck disability index', 'timeFrame': '4 weeks', 'description': 'It includes 10 questions of which 7 examine functional activities, 2 ask about symptoms and a question considers concentration.\n\nEach Patient will circle one of the six options describing the severity of each item (0 5). total score for the questionnaire out of 50. Higher scores represent greater disability.'}, {'measure': 'Electromyography', 'timeFrame': '4 weeks', 'description': 'used for measuring upper trapezius normalized Root mean square to indicate muscular activities and median frequence to indicate muscular fatigue. Active electrode will be located 2 cm lateral to the midpoint of a line drawn between C7 spinous process and the posterolateral acromion while the reference one will be located over the C7 spinous process.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['electromyographic', 'Tui-Na massage', 'positional release', 'postpartum neck dysfunction'], 'conditions': ['Postpartum Neck Dysfunction']}, 'descriptionModule': {'briefSummary': 'To investigate the effects of Tui- Na massage versus Positional release technique on neck pain intensity, neck disability, and electromyographic characteristics of upper trapezius muscle.', 'detailedDescription': 'Positional release technique'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age ranged from 20- 40 years\n* had post partum cervical pain\n* score above 15 in the neck disability index (NDI\n\nExclusion Criteria:\n\n* Patients with structural, inflammatory, infectious, metabolic, congenital, traumatic spinal disorders and spinal or upper limb surgery.'}, 'identificationModule': {'nctId': 'NCT07261605', 'briefTitle': 'Clinical and Electromyographic Effect of Tui Na Massage Versus Positional Release on Postpartum Neck Dysfunction', 'organization': {'class': 'OTHER', 'fullName': 'October 6 University'}, 'officialTitle': 'Clinical and Electromyographic Effect of Tui Na Massage Versus Positional Release on Postpartum Neck Dysfunction A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'PT.BU.EC.20'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'postural correction', 'description': '20 patients: will receive postural correction exercises program only.', 'interventionNames': ['Procedure: postural correction exercises']}, {'type': 'EXPERIMENTAL', 'label': 'Tui NA massage', 'description': '20 patients: will receive postural correction exercises program. In addition, an experienced therapist will apply the Tui Na massage to the cervical region', 'interventionNames': ['Procedure: Tui-Na massage']}, {'type': 'EXPERIMENTAL', 'label': 'Positional release', 'description': '20 patients: will receive postural correction exercises program. In addition, the therapist put the patient in a comfortable posture for ninety seconds, after which they passively will be moved back to their initial positions', 'interventionNames': ['Procedure: positional release']}], 'interventions': [{'name': 'postural correction exercises', 'type': 'PROCEDURE', 'description': 'A combination of yoga, stretching, and strengthening exercises may help you to fix or correct your posture over time.\n\nMaintaining good posture is important for helping you develop strength, flexibility, and balance.', 'armGroupLabels': ['postural correction']}, {'name': 'Tui-Na massage', 'type': 'PROCEDURE', 'description': 'Tuina massage is similar to acupuncture in that it targets specific acupoints, but practitioners use fingers instead of needles to apply pressure to stimulate these points. Tuina massage is often used in combination with acupuncture.', 'armGroupLabels': ['Tui NA massage']}, {'name': 'positional release', 'type': 'PROCEDURE', 'description': 'is a passive manual manipulation method used to alleviate musculoskeletal pain and dysfunction.', 'armGroupLabels': ['Positional release']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Kerolous ishak shehata kelini', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'October 6 University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of physical therapy department of women health', 'investigatorFullName': 'Kerolous Ishak Shehata', 'investigatorAffiliation': 'October 6 University'}}}}