Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2025-12-26 @ 2:36 AM
Study NCT ID:
NCT07187102
Status:
RECRUITING
Last Update Posted:
2025-09-22
First Post:
2025-09-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ultrasonographic Response to Cervical and Upper Thoracic SNAG in Medial Epicondylitis, Randomized Clinical Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070639', 'term': 'Elbow Tendinopathy'}], 'ancestors': [{'id': 'D052256', 'term': 'Tendinopathy'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D000092464', 'term': 'Elbow Injuries'}, {'id': 'D001134', 'term': 'Arm Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D013708', 'term': 'Tendon Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Open Label - both participants and investigators will be aware of the intervention received'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'one group receive SNAG plus traditional treatment second group receive traditional treatment'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-09-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-15', 'studyFirstSubmitDate': '2025-09-15', 'studyFirstSubmitQcDate': '2025-09-15', 'lastUpdatePostDateStruct': {'date': '2025-09-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-10-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in hypervascularity and hypoechogencity measured by colour sonography ( grade 1: grade 4)', 'timeFrame': '2 months', 'description': 'Change in hypervascularity and hypoechogencity measured by colour sonography ( grade 1: grade 4)'}, {'measure': 'Change in shoulder disability measured by DASH SCALE and elbow disability by PRTEE scale )', 'timeFrame': '2 MONTHS', 'description': 'Change in shoulder disability measured by DASH SCALE and elbow disability by PRTEE scale )'}, {'measure': 'Change in pain intensity measured by Visual Analogue Scale (VAS, 0-10 points)', 'timeFrame': '2 months', 'description': 'Change in pain intensity measured by Visual Analogue Scale (VAS, 0-10 points)'}, {'measure': 'Change in grip muscle strength measured by hand held dynamometer points', 'timeFrame': '2 months', 'description': 'Change in grip muscle strength measured by hand held dynamometer points'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['mobilization , SNAG , medial epicondylitis'], 'conditions': ['Medial Epicondylitis']}, 'descriptionModule': {'briefSummary': 'Aim of the work :\n\n1. To detect if there is any change would occur in the neovascularity and echogenicity after using cervical and upper thoracic SNAG or not in ME patients.\n2. To find the effect of cervical and upper thoracic SNAG on pain, function of upper extremities, grip strength in ME comparing with traditional treatment alone', 'detailedDescription': "medial epicondylitis(ME) of the elbow is a condition characterized by aggravation of pain in the outer part of the elbow during active wrist flexion , and presentation of pain on direct palpation of the medial epicondyle, or proximal muscle belly . Biomechanical and sensorimotor deficits can occur and adversely impact upper extremity function .These functional deficits may interfere with occupational tasks and activities of daily living The study's results: Measuring the changes that will be produced by using therapeutic growth of the cervical and thoracic vertebrae on the pathological changes that persist in the tendons of the tens of the tibialis cruciate ligaments in detecting excess weight resulting from the disease of the middle epicondyle, such as increased blood vessels in the tendon and decreased echogenicity of the tendon, in addition to measuring the changes that occurred in the extent of pain sensation and the extent of functional performance of the shoulder and elbow joints. Patients will be directly selected jointly according to the patient's specifications for the research and written consent will be obtained from the patient after a detailed explanation of the research steps and what is required of him. The vocal function of the tendon will be evaluated, with the exception of functional pain of the successful upper extremity and the strength of the hand muscles before and after the experiment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ranges from 35 to 50 years old in both sexes.\n* Patients with LE that diagnosed by orthopedist.\n* Pain onset is more than 3 months appear primarily with use or rest or in both, also , it appear with deep palpation of the medial epicondyle .\n\nExclusion Criteria:\n\n* • Rheumatoid Arthritis .\n\n * Skin infection.\n * History of previous elbow surgery.\n * Any pathology in the shoulder joint.\n * Neurologic deficit in upper extremity.\n * Cervical disc prolapse and radiculopathy C5,6.\n * Dislocation of elbow joint.\n * Recent fractures of upper extremity.\n * Arthrosis of the radiohumeral joint.\n * Osteochondritis dissecans.\n * Osteonecrosis.\n * Plica synovialis.\n * Participants receiving other treatment, in the form of physical therapy or medication, for the duration of the study that may interfere with the results of this study.'}, 'identificationModule': {'nctId': 'NCT07187102', 'briefTitle': 'Ultrasonographic Response to Cervical and Upper Thoracic SNAG in Medial Epicondylitis, Randomized Clinical Trial', 'organization': {'class': 'OTHER', 'fullName': 'Beni-Suef University'}, 'officialTitle': 'Ultrasonographic Response to Cervical and Upper Thoracic SNAG in Treatment of Chronic Medial Epicondylitis, Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'FMBSUREC/07092025/Ahmed'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'experimental group', 'description': 'Participants will receive the physiotherapy SNAG plus traditional treatment program (4weeks, supervised sessions 3 times per week )', 'interventionNames': ['Other: SNAG ( sustained natural apopheseal glide )']}, {'type': 'OTHER', 'label': 'control group', 'description': 'Participants will receive the physiotherapy traditional treatment program (4weeks, supervised sessions 3 times per week )', 'interventionNames': ['Other: SNAG ( sustained natural apopheseal glide )']}], 'interventions': [{'name': 'SNAG ( sustained natural apopheseal glide )', 'type': 'OTHER', 'description': 'SNAG : type of mobilization of vertebral coulmn', 'armGroupLabels': ['control group', 'experimental group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Banī Suwayf', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Sahar M Abdelmutilibe', 'role': 'CONTACT', 'email': 'sahar.mowad@pt.bsu.edu.eg', 'phone': '0021027620061'}], 'facility': 'Faculty of Physical Therapy, Beni-Suef University', 'geoPoint': {'lat': 29.07441, 'lon': 31.09785}}], 'centralContacts': [{'name': 'Sahar M Abdelmutilibe, PHD', 'role': 'CONTACT', 'email': 'sahar.mowad@pt.bsu.edu.eg', 'phone': '0021027620061'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': '"No, there is no plan to make individual participant data (IPD) available to other researchers due to privacy concerns and institutional restrictions."'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beni-Suef University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'faculty of physical therapy , beni suef university', 'investigatorFullName': 'Sahar Mowad Abdelmutilibe', 'investigatorAffiliation': 'Beni-Suef University'}}}}