Ignite Creation Date:
2025-12-24 @ 5:05 PM
Ignite Modification Date:
2025-12-28 @ 6:23 AM
Study NCT ID:
NCT05913050
Status:
SUSPENDED
Last Update Posted:
2025-05-25
First Post:
2023-06-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Predicting ROtator Cuff Tears Outcomes After Physical Therapy Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070636', 'term': 'Rotator Cuff Injuries'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D012421', 'term': 'Rupture'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D000070599', 'term': 'Shoulder Injuries'}, {'id': 'D013708', 'term': 'Tendon Injuries'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004522', 'term': 'Educational Status'}], 'ancestors': [{'id': 'D012959', 'term': 'Socioeconomic Factors'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'The study will be a non-controlled multicenter clinical trial with the main aim of developing a multivariable prediction model of the improvements after a physical therapy treatment based on exercise and education.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 386}}, 'statusModule': {'whyStopped': 'Financial support for the project has been discontinued.', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-09-18', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-21', 'studyFirstSubmitDate': '2023-06-09', 'studyFirstSubmitQcDate': '2023-06-16', 'lastUpdatePostDateStruct': {'date': '2025-05-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-18', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Pain catastrophizing', 'timeFrame': 'Baseline', 'description': 'Pain catastrophizing measured with the Pain Catastrophizing Scale, which ranges from 0 (minimum degree of catastrophizing) to 100 (maximum degree of catastrophizing).'}, {'measure': "Patient's expectations", 'timeFrame': 'Baseline', 'description': "Patient's expectations of improvement with therapeutic exercise measured with the Musculoskeletal Outcomes Data Evaluation and Management System, which ranges from 0 (minimum degree of expectations) to 100 (maximum degree of expectations)."}], 'primaryOutcomes': [{'measure': 'Shoulder disability', 'timeFrame': 'Change from baseline to 3-month, change from baseline to 6-month, and change from baseline to 1-year.', 'description': 'Shoulder disability measured with the Shoulder Pain and Disability Index, which ranges from 0 (no disability) to 100 (maximum degree of disability).'}], 'secondaryOutcomes': [{'measure': 'Shoulder pain intensity', 'timeFrame': 'Change from baseline to 3-month, change from baseline to 6-month, and change from baseline to 1-year.', 'description': 'Shoulder pain intensity measured with a numeric pain rating scale, which ranges from 0 (no pain) to 10 (worst imaginable pain).'}, {'measure': 'Need for surgery', 'timeFrame': '3-month, 6-month, and 1-year.', 'description': 'Need for surgery for the rotator cuff tear registered as a dichotomous variable (YES/NO).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Physical therapy', 'Rotator cuff', 'Full-thickness tear', 'Exercise', 'Education', 'Prediction model'], 'conditions': ['Rotator Cuff Injuries']}, 'descriptionModule': {'briefSummary': 'The aim of this multicenter non-controlled study is to develop a multivariable prediction model of pain/disability improvements in patients with full-thickness rotator cuff tears, after a physical therapy treatment based on therapeutic exercise and education.', 'detailedDescription': "A multivariable prediction model for the improvement in shoulder pain and disability will be developed based on the following predictors:\n\n* Body mass index \\[kg/m2, Fractional polynomials FP2\\].\n* Smoking \\[Years, linear relationship\\].\n* Employment status \\[3 categories\\].\n* Maximum education degree \\[4 categories\\].\n* Previous performance of physical exercise \\[2 categories\\].\n* Baseline disability (measured with the Shoulder Pain and Disability Index) \\[Fractional polynomials FP2\\].\n* Baseline pain intensity (measured with a numeric pain rating scale) \\[Fractional polynomials FP2\\].\n* Pain duration \\[Weeks, linear relationship\\]\n* Pain catastrophizing (measured with the Pain Catastrophizing Scale) \\[Linear relationship\\].\n* Patient's expectations (measured with the Musculoskeletal Outcomes Data Evaluation and Management System) \\[Linear relationship\\]."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Full-thickness supraspinatus rotator cuff tear diagnosed by ultrasound imaging or magnetic resonance imaging.\n* Pain during resisted abduction and/or external rotation.\n* Pain intensity equal or greater to 3 points on a numeric pain rating scale, or a degree of disability equal or greater to 15% on the Shoulder Pain and Disability Index.\n* Pain lasting for at least 3 months.\n* Adequate comprehension of written and spoken Spanish\n\nExclusion Criteria:\n\n* Loss of passive external rotation at 0º of shoulder abduction equal or greater to 50% compared to contralateral side.\n* Suspected neck-related shoulder pain.\n* Suspected visceral-related shoulder pain.\n* Sings or symptoms of shoulder instability, including dislocations and/or subluxation within the last year.\n* Humerus and/or scapular fractures within the last year.\n* Previous rotator cuff repair surgery within the last year.\n* Presence of cancer, fibromyalgia, neurological and/or other systemic diseases.\n* Cognitive impairment that makes it impossible to perform therapeutic exercise.'}, 'identificationModule': {'nctId': 'NCT05913050', 'acronym': 'PROTO', 'briefTitle': 'Predicting ROtator Cuff Tears Outcomes After Physical Therapy Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Universitario Fundación Alcorcón'}, 'officialTitle': 'Predicting ROtator Cuff Tears Outcomes After Physical Therapy Treatment (the PROTO Study): a Multivariable Prediction Model Development Study', 'orgStudyIdInfo': {'id': '23/66'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Therapeutic exercise plus education', 'description': 'The treatment will consist of a progressive resistance exercise program along with education.', 'interventionNames': ['Other: Therapeutic resistance exercise', 'Other: Education']}], 'interventions': [{'name': 'Therapeutic resistance exercise', 'type': 'OTHER', 'description': 'Therapeutic exercise program based on individualized progressive resistance exercises performed during 3 months at home, with a frequency of 1-3 sessions per week at the hospital.', 'armGroupLabels': ['Therapeutic exercise plus education']}, {'name': 'Education', 'type': 'OTHER', 'description': "Education applied during all the therapeutic process, focusing on diverting the patient's attention away from the structural lesion, explaining the relationship between pain/disability and tissue injury, explaining the meaning of pain during exercises, and explaining the objectives of the implemented treatments.", 'armGroupLabels': ['Therapeutic exercise plus education']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Univeristario Fundación Alcorcón', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'IPD data will be shared with other researcher upon reasonable request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Universitario Fundación Alcorcón', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hospital Universitario de Fuenlabrada', 'class': 'OTHER'}, {'name': 'Hospital Universitario Infanta Leonor - Vallecas / Hospital Virgen de la Torre', 'class': 'UNKNOWN'}, {'name': 'Hospital Universitario La Paz', 'class': 'OTHER'}, {'name': 'Hospital Universitario Ramon y Cajal', 'class': 'OTHER'}, {'name': 'Hospital Universitario La Princesa', 'class': 'UNKNOWN'}, {'name': 'Hospital General Universitario Gregorio Marañon', 'class': 'OTHER'}, {'name': 'Hospital Universitario Principe de Asturias', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Rubén Fernández Matías', 'investigatorAffiliation': 'Hospital Universitario Fundación Alcorcón'}}}}