Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2026-01-02 @ 1:23 AM
Study NCT ID:
NCT05917756
Status:
UNKNOWN
Last Update Posted:
2023-06-26
First Post:
2023-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mobilization With Movement on Pain, Function, and Quality of Life in Patients With Thoracic Outlet Syndrome
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009068', 'term': 'Movement'}], 'ancestors': [{'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two-arm randomized controlled trial with an equal allocation ratio (1:1) for the experimental and control groups'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-07-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2024-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-06-15', 'studyFirstSubmitDate': '2023-06-15', 'studyFirstSubmitQcDate': '2023-06-15', 'lastUpdatePostDateStruct': {'date': '2023-06-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in Pain Intensity', 'timeFrame': 'Changes in Pain intensity at Baseline, 4 weeks, 8 weeks, and 12 weeks (follow-up)', 'description': 'Pain intensity will be assessed using the Numeric Pain Rating Scale (NPRS).'}], 'secondaryOutcomes': [{'measure': 'Changes in Functional Status', 'timeFrame': 'Changes in Functional Status Baseline, 4 weeks, 8 weeks, and 12 weeks (follow-up)', 'description': 'Functional status will be evaluated using the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire.'}, {'measure': 'Changes in Cervical Range of Motion', 'timeFrame': 'Baseline, 4 weeks, 8 weeks, and 12 weeks (follow-up)', 'description': 'Cervical range of motion will be assessed using a goniometer.'}, {'measure': 'Changes in Quality of Life', 'timeFrame': 'Changes in quality of life at Baseline, 4 weeks, 8 weeks, and 12 weeks (follow-up)aseline, 4 weeks, 8 weeks, and 12 weeks (follow-up)', 'description': 'Quality of life will be assessed using the Short Form-36 (SF-36) questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Thoracic Outlet Syndrome']}, 'descriptionModule': {'briefSummary': 'This randomized controlled trial aims to evaluate the effects of Mobilization with Movement (MWM) on pain, function, and quality of life in patients with Thoracic Outlet Syndrome (TOS) compared to conventional physiotherapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged 18-65 years, diagnosed with TOS by a specialist, and experiencing symptoms for at least 3 months\n\nExclusion Criteria:\n\n* Previous surgery for TOS\n* contraindications to manual therapy\n* other comorbidities significantly affecting upper limb function'}, 'identificationModule': {'nctId': 'NCT05917756', 'briefTitle': 'Mobilization With Movement on Pain, Function, and Quality of Life in Patients With Thoracic Outlet Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Ahram Canadian University'}, 'officialTitle': 'The Impact of Mobilization With Movement on Pain, Function, and Quality of Life in Patients With Thoracic Outlet Syndrome: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '012/0333666'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A (experimental group)', 'description': 'MWM techniques combined with a tailored therapeutic exercise program', 'interventionNames': ['Other: Mobilization with Movement (MWM) and Tailored Therapeutic Exercise Program']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B (control group)', 'description': 'Conventional physiotherapy combined with a tailored therapeutic exercise program', 'interventionNames': ['Other: Conventional Physiotherapy']}], 'interventions': [{'name': 'Mobilization with Movement (MWM) and Tailored Therapeutic Exercise Program', 'type': 'OTHER', 'description': 'The intervention consists of MWM techniques targeting the cervical and thoracic spine, and the first rib, applied by a certified physiotherapist for 8 weeks, 2 sessions per week, each session lasting 45 minutes. The intervention also includes a tailored therapeutic exercise program for the patients, comprising postural correction, stretching, and strengthening exercises. This intervention will be compared to conventional physiotherapy in the control group.', 'armGroupLabels': ['Group A (experimental group)']}, {'name': 'Conventional Physiotherapy', 'type': 'OTHER', 'description': 'Conventional physiotherapy, including manual therapy (soft tissue mobilization, joint mobilization, and nerve gliding techniques) for 8 weeks, 2 sessions per week, each session lasting 45 minutes, combined with a tailored therapeutic exercise program (including postural correction, stretching, and strengthening exercises).', 'armGroupLabels': ['Group B (control group)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3221405', 'city': 'Al Ḩayy Ath Thāmin', 'state': 'Giza Governorate', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Mohamed M ElMeligie, Ph.d', 'role': 'CONTACT', 'email': 'mohamed.elmeligie@acu.edu.eg', 'phone': '01064442032'}], 'facility': 'Outpatient clinic of faculty of physical therapy, Ahram Canadian University'}], 'centralContacts': [{'name': 'Mohamed M ElMeligie, Ph.d', 'role': 'CONTACT', 'email': 'mohamed.elmeligie@acu.edu.eg', 'phone': '+201064442032'}], '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'}}}}