Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-26 @ 3:03 AM
Study NCT ID:
NCT05695820
Status:
COMPLETED
Last Update Posted:
2025-02-26
First Post:
2023-01-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Low- Load Strengthening Using Different Exercises Modes During Blood Flow Restriction for Treating Shoulder Impingement Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019534', 'term': 'Shoulder Impingement Syndrome'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D000070599', 'term': 'Shoulder Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000090003', 'term': 'Blood Flow Restriction Therapy'}], 'ancestors': [{'id': 'D005081', 'term': 'Exercise Therapy'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Sealed envelope'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized Parallel Groups Clinical Trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-24', 'studyFirstSubmitDate': '2023-01-11', 'studyFirstSubmitQcDate': '2023-01-13', 'lastUpdatePostDateStruct': {'date': '2025-02-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Muscle strength', 'timeFrame': '20 minutes', 'description': 'All HHD assessments will be done in the form of three trials of 3 seconds of maximal isometric contraction and a 10-second rest period between each measurement. The mean peak force, will be recorded in kilograms (Kgs), and used as the strength measure'}], 'secondaryOutcomes': [{'measure': 'Functional assessment', 'timeFrame': '20 minutes', 'description': 'By DASH questionnaire'}, {'measure': 'Pain assessment', 'timeFrame': '15 minutes', 'description': 'By visual analogue scale'}, {'measure': 'Range of motion', 'timeFrame': '20 minutes', 'description': 'By bubble inclinometer'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Blood flow restriction/ shoulder impingement syndrome'], 'conditions': ['Shoulder Impingement Syndrome']}, 'descriptionModule': {'briefSummary': 'Purpose of the study: This study compares effects of isometric, concentric and eccentric exercises for shoulder muscles by using low load blood flow restriction training on pain, strength and function in patients with SIS.', 'detailedDescription': 'This study will be conducted at El hadra university hospital, Alexandria, Egypt. Study Design: Randomized Parallel Groups Clinical Trial. Participants: Sixty patients of both genders with unilateral shoulder impingement syndrome, with age range from 30-40 years will be randomly assigned to 1 of 3 groups. All patients will be referred by the orthopedic surgeon who will diagnose shoulder impingement syndrome based on clinical and radiological examination. Group 1: twenty patients will receive concentric training of rotator cuff muscles while applying blood flow restriction for 4 weeks. Group 2: twenty patients will receive eccentric training of rotator cuff muscles while applying blood flow restriction for 4 weeks. Group 3: twenty patients will receive isometric training of rotator cuff muscles while applying blood flow restriction for 4 weeks. The assessment for all groups will be done at baseline and after 4 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\nAge range 30-40 years. - Pain localized to the proximal anterolateral shoulder region, - Positive for pain on at least one of the following three impingement tests: Hawkins-Kennedy, Neers, Jobes and Positive for pain on at least one of the following four tests: Painful arc, drop arm test, lift off test, and resisted external rotation (Fatima et al., 2021\n\nExclusion Criteria:\n\n* Large, full-thickness rotator cuff tear, Moderate, severe glenohumeral or acromioclavicular joint osteoarthritis. - Glenohumeral joint instability including previous shoulder dislocation/subluxation. - Previous shoulder fracture. - Current neck pain/dysfunction with a somatic or radicular referral pattern indicative of cervical spine rather than shoulder as primary source of symptoms and/or pathology. - Neurological deficits of the upper limb. - Systemic inflammatory arthritic conditions (Fatima et al., 2021).'}, 'identificationModule': {'nctId': 'NCT05695820', 'briefTitle': 'Effects of Low- Load Strengthening Using Different Exercises Modes During Blood Flow Restriction for Treating Shoulder Impingement Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Effects of Low- Load Strengthening Using Different Exercises Modes During Blood Flow Restriction for Treating Shoulder Impingement Syndrome', 'orgStudyIdInfo': {'id': 'P.T.REC/012/004174'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Concentric', 'description': 'Concentric group', 'interventionNames': ['Other: Blood Flow Restriction training']}, {'type': 'EXPERIMENTAL', 'label': 'Isometric', 'description': 'Isometric group', 'interventionNames': ['Other: Blood Flow Restriction training']}, {'type': 'EXPERIMENTAL', 'label': 'Eccentric', 'description': 'Eccentric group', 'interventionNames': ['Other: Blood Flow Restriction training']}], 'interventions': [{'name': 'Blood Flow Restriction training', 'type': 'OTHER', 'description': 'It is a method that involves reducing blood flow to a muscle by the application of an external constricting device, such as a blood pressure cuff or tourniquet, to provide mechanical compression of the underlying blood vessels. BFR is applied aiming to enhance blood pooling in the capillary beds of the limb muscles distal to the tourniquet', 'armGroupLabels': ['Concentric', 'Eccentric', 'Isometric']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'CairoU', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Ahmed Ma Gad', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cairo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Website'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Msc degree in physical therapy', 'investigatorFullName': 'Ahmed Mahmoud Gad Moussa', 'investigatorAffiliation': 'Cairo University'}}}}