Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-31 @ 8:48 PM
Study NCT ID:
NCT05934734
Status:
COMPLETED
Last Update Posted:
2024-06-04
First Post:
2023-06-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of Thoracic Outlet Syndrome Severity on Upper Extremity Function and Neural Integrity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013901', 'term': 'Thoracic Outlet Syndrome'}], 'ancestors': [{'id': 'D009408', 'term': 'Nerve Compression Syndromes'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 136}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-06-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-05-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-01', 'studyFirstSubmitDate': '2023-06-28', 'studyFirstSubmitQcDate': '2023-07-05', 'lastUpdatePostDateStruct': {'date': '2024-06-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Range of Motion (ROM) of the Shoulder joint', 'timeFrame': 'Baseline', 'description': 'Active and passive ROM will be measured using a standard goniometer.'}, {'measure': 'Range of Motion (ROM) of the Elbow joint', 'timeFrame': 'Baseline', 'description': 'Active and passive ROM will be measured using a standard goniometer.'}, {'measure': 'Range of Motion (ROM) of the Wrist joint', 'timeFrame': 'Baseline', 'description': 'Active and passive ROM will be measured using a standard goniometer.'}, {'measure': 'Isometric Muscle Strength of shoulder', 'timeFrame': 'Baseline', 'description': 'Maximum voluntary isometric strength of shoulder muscles will be measured using a handheld dynamometer.'}, {'measure': 'Isometric Muscle Strength of elbow', 'timeFrame': 'Baseline', 'description': 'Maximum voluntary isometric strength of elbow muscles will be measured using a handheld dynamometer.'}, {'measure': 'Isometric Muscle Strength of wrist', 'timeFrame': 'Baseline', 'description': 'Maximum voluntary isometric strength of wrist muscles will be measured using a handheld dynamometer.'}, {'measure': 'Self-reported upper extremity function', 'timeFrame': 'Baseline', 'description': 'The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire, developed by the Institute for Work and Health, is used to measure patient-reported functional outcomes. The DASH questionnaire consists of 30 questions regarding limitations to complete physical activities due to upper extremity pain/impairment. Participants will be asked to respond to each question based on their experiences over the preceding week according to a 5-point Likert scale ranging from 1 (no difficulty) to 5 (unable to do). Responses will be scored out of 5 and averaged to produce a score out of 100 with higher scores representing greater disability.'}, {'measure': 'Nerve Conduction Studies of ulnar nerve', 'timeFrame': 'Baseline', 'description': 'Nerve conduction studies will assess the function/integrity of the ulnar nerve.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Thoracic Outlet Syndrome']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the relationship between the severity of thoracic outlet syndrome and upper extremity function, as well as neural integrity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'A total of 100 individuals (n=25 per cohort), aged 18-65 years, diagnosed with thoracic outlet syndrome will be recruited for this study. Participants will be recruited from local physical therapy clinics and physician offices. Participants will be screened for eligibility prior to being enrolled in the study and stratified into one of four cohorts based on the severity of self-reported symptoms using a visual analog scale: mild (scores 1-3), moderate (scores 4-6), severe (scores 7-9) and very severe (score 10). Exclusion criteria include a history of upper extremity surgery or other upper extremity disorders not related to thoracic outlet syndrome. All participants will provide written informed consent prior to participating in the study assessments.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-65 years\n* Diagnosed with thoracic outlet syndrome\n* Willing and able to provide informed consent\n\nExclusion Criteria:\n\n* History of upper extremity surgery unrelated to thoracic outlet syndrome\n* Other upper extremity disorders unrelated to thoracic outlet syndrome'}, 'identificationModule': {'nctId': 'NCT05934734', 'briefTitle': 'Influence of Thoracic Outlet Syndrome Severity on Upper Extremity Function and Neural Integrity', 'organization': {'class': 'OTHER', 'fullName': 'Ahram Canadian University'}, 'officialTitle': 'The Influence of Thoracic Outlet Syndrome Severity on Upper Extremity Function and Neural Integrity: A Cross-Sectional Study', 'orgStudyIdInfo': {'id': '09876543'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort 1 (Mild)', 'description': 'Participants with mild self-reported thoracic outlet syndrome symptoms (visual analog scale score 1-3).', 'interventionNames': ['Other: No intervention']}, {'label': 'Cohort 2 (Moderate)', 'description': 'Participants with moderate self-reported thoracic outlet syndrome symptoms (visual analog scale score 4-6). No intervention will be provided.', 'interventionNames': ['Other: No intervention']}, {'label': 'Cohort 3 (Severe)', 'description': 'participants with severe self-reported thoracic outlet syndrome symptoms (visual analog scale score 7-9). No intervention will be provided', 'interventionNames': ['Other: No intervention']}, {'label': 'Cohort 4 (Very Severe)', 'description': 'Participants with very severe self-reported thoracic outlet syndrome symptoms (visual analog scale score 10). No intervention will be provided.', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'This is an observational cross-sectional study. No intervention will be provided. Participants will be assessed and stratified into four cohorts based on self-reported symptom severity of thoracic outlet syndrome using a visual analog scale (VAS) to investigate the relationship between symptom severity and upper extremity function/neural integrity.', 'armGroupLabels': ['Cohort 1 (Mild)', 'Cohort 2 (Moderate)', 'Cohort 3 (Severe)', 'Cohort 4 (Very Severe)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3221405', 'city': 'Al Ḩayy Ath Thāmin', 'state': 'Giza Governorate', 'country': 'Egypt', 'facility': 'Outpatient clinic of faculty of physical therapy, Ahram Canadian University'}], 'overallOfficials': [{'name': 'Amal Fawzy, Ph.d', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Faculty of Physical Therapy, Ahram Canadian University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ahram Canadian University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Physical Therapy and Director of Electromyography Lab', 'investigatorFullName': 'Mohamed Magdy ElMeligie', 'investigatorAffiliation': 'Ahram Canadian University'}}}}