Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 7:22 AM
Study NCT ID:
NCT07324993
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-10
First Post:
2025-12-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of a 4-week Low-intensity Training With Blood Flow Restriction in People With Rotator Cuff-related Shoulder Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 34}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-07', 'studyFirstSubmitDate': '2025-12-23', 'studyFirstSubmitQcDate': '2025-12-23', 'lastUpdatePostDateStruct': {'date': '2026-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain intensity during movement (Visual Analogue Scale, 0-10)', 'timeFrame': 'Baseline, 2 weeks, and 4 weeks.', 'description': 'Pain intensity perceived on a Visual Analogue Scale during movement (flexion and abduction movement without load), being 0 no pain and 10 the worst pain imaginable.'}], 'secondaryOutcomes': [{'measure': 'Pain intensity at rest (Visual Analogue Scale, 0-10)', 'timeFrame': 'Baseline, 2 weeks, and 4 weeks.', 'description': 'Pain intensity perceived on a Visual Analogue Scale, at rest, being 0 no pain and 10 the worst pain imaginable.'}, {'measure': 'Pressure pain threshold', 'timeFrame': 'Before the session, immediately after, and 1 hour post-intervention', 'description': 'Pressure pain threshold measured in the middle deltoid (peripheral sensitivity) and tibialis anterior (central sensitivity), using an algometer.'}, {'measure': 'Kinesiophobia', 'timeFrame': 'Baseline, 2 weeks, and 4 weeks.', 'description': 'Assessment of fear of movement or reinjury, assessed via the self-administered Tampa Scale of Kinesiophobia questionnaire.'}, {'measure': 'Occurrence of adverse effects', 'timeFrame': 'Immediately after the intervention, 1 hour, 6 hours, 24 hours.', 'description': 'Occurrence of adverse effects (e.g., pain, delayed onset muscle soreness, sudden weakness of the trained limb, redness or swelling of the trained limb, etc.) by self-report.'}, {'measure': 'Pain Catastrophizing', 'timeFrame': 'Baseline, 2 weeks, and 4 weeks.', 'description': 'Assessment of pain catastrophizing, measured using the self-report Pain Catastrophizing Scale (PCS), which evaluates exaggerated negative mental responses to actual or anticipated pain. The final score ranges from 0 to 52, with higher scores reflecting higher levels of catastrophizing.'}, {'measure': 'Pain and Disability', 'timeFrame': 'Baseline, 2 weeks, and 4 weeks.', 'description': 'Assessment of pain and disability, measured using the self-report Shoulder Pain and Disability Index (SPADI). The score ranges from 0 to 100. A score of 0 indicates best, 100 indicates worst. A higher score shows more disabillity.'}, {'measure': 'Shoulder Disability', 'timeFrame': 'Baseline, 2 weeks, and 4 weeks.', 'description': 'Assessment of shoulder disability, measured using the self-report Disabilities of the Arm, Shoulder, and Hand questionnaire (DASH). The final score ranges from 0 (no disability) to 100 (severe/maximal disability), calculated from patient-rated difficulty on a 5-point scale for 30 items, with higher scores indicating greater impairment in arm, shoulder, and hand function.'}, {'measure': 'Muscle Strength', 'timeFrame': 'Baseline, 2 weeks, and 4 weeks.', 'description': 'Assessment of supraspinatus and internal and external rotator muscle strength, measured using a strap-secured handheld dynamometer.'}, {'measure': 'Satisfaction with methodology', 'timeFrame': '4 weeks.', 'description': 'Assessment of participant satisfaction with the methodology used, measured at the end of the program using a 5-point scale: very satisfied (5), satisfied (4), neutral (3), dissatisfied (2), very dissatisfied (1).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['blood flow restriction', 'exercise', 'rotator cuff-related shoulder pain'], 'conditions': ['Rotator Cuff Related Shoulder Pain']}, 'descriptionModule': {'briefSummary': 'This study aims to analyze the effects of 4 weeks of low-intensity exercise with and without blood flow restriction (BFR) on pain, fear of movement, catastrophizing about pain, strength, and disability in a population with rotator cuff-related shoulder pain. There are two modalities corresponding to the same exercises under different blood flow restriction conditions: 1) 3 low-intensity exercises (30% 1RM) with BFR (50% AOP); 2) 3 low-intensity exercises (30% 1RM) without BFR.\n\nParticipants will be randomly assigned to one of two groups and will undergo a 4-week intervention. The variables of interest will be assessed in each group for subsequent analysis and comparison.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18 and 65.\n* Shoulder symptoms lasting at least 3 months.\n* Pain in the proximal anterolateral aspect of the shoulder, aggravated by abduction.\n* At least two of the following tests positive: Jobe test, resisted external rotation test, Hawkins-Kennedy test, Neer test, painful arc between 60 and 120 degrees of shoulder abduction.\n\nExclusion Criteria:\n\n* Pain of an intensity that prevents performance of the proposed exercises.\n* Active arm elevation less than 90 degrees.\n* Clinical signs of a complete tear (positive delayed external and internal rotation sign and positive drop arm test).\n* Suspected frozen shoulder (50% reduction or more than 30° loss of passive shoulder external rotation).\n* Primary diagnosis of shoulder instability or acromioclavicular pathology.\n* Shoulder pain due to primary involvement in the cervical or thoracic region\n* Corticosteroid injection within the last 6 weeks.\n* Presence of diseases such as inflammatory arthritis, neurological diseases, fibromyalgia, malignant tumors, or polymyalgia rheumatica.\n* Presence of comorbidities that increase cardiovascular risk, such as hypertension, diabetes, or heart failure.\n* Presence of more than one thromboembolism risk factor (obesity, history of thrombosis, prolonged immobilization, recent surgery, use of contraceptives, etc.).\n* Presence of active skin lesions in the area where the sleeve will be placed, recent scars or burns, or chronic dermatological diseases that compromise skin integrity,\n* Participation in upper limb exercise programs in the last month.'}, 'identificationModule': {'nctId': 'NCT07324993', 'briefTitle': 'Effects of a 4-week Low-intensity Training With Blood Flow Restriction in People With Rotator Cuff-related Shoulder Pain', 'organization': {'class': 'OTHER', 'fullName': 'University of Valencia'}, 'officialTitle': 'Analysis of the Effects of a 4-week Low-intensity Training With and Without Blood Flow Restriction in People With Rotator Cuff-related Shoulder Pain', 'orgStudyIdInfo': {'id': '2025-FIS-3960959'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Low resistance exercise with blood occlusion', 'description': 'Eight sessions of exercise during 4 weeks, 30% repetition maximum, and 50% blood occlusion', 'interventionNames': ['Device: Resistance exercise with BFR']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Low resistance exercise without blood flow restriction', 'description': 'Eight sessions of exercise during 4 weeks, 30% repetition maximum, without blood occlusion', 'interventionNames': ['Procedure: Resistance exercise without BFR']}], 'interventions': [{'name': 'Resistance exercise with BFR', 'type': 'DEVICE', 'description': 'Three exercises: external rotation at 0°, internal rotation at 0° and elevation in the scapular plane. 4 sets (30, 15, 15, reps to fatigue) with a intensity of 30% RM and a 50% of arterial occlusion pressure. 30" rest between sets, 2\' rest between exercises.', 'armGroupLabels': ['Low resistance exercise with blood occlusion']}, {'name': 'Resistance exercise without BFR', 'type': 'PROCEDURE', 'description': 'Three exercises: external rotation at 0°, internal rotation at 0° and elevation in the scapular plane. 4 sets (30, 15, 15, reps to fatigue) with a intensity of 30% RM and a without flow restriction application (cuff applied without pressure). 30" rest between sets, 2\' rest between exercises.', 'armGroupLabels': ['Low resistance exercise without blood flow restriction']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Adrian Escriche-Escuder, PhD', 'role': 'CONTACT', 'email': 'adrian.escriche@uv.es', 'phone': '+34 963 98 38 55'}], 'overallOfficials': [{'name': 'Adrián Escriche-Escuder, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitat de València'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The data that support the findings of this study will be available from the corresponding author upon reasonable request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Valencia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Adrián Escriche Escuder', 'investigatorAffiliation': 'University of Valencia'}}}}