Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2025-12-26 @ 2:46 AM
Study NCT ID:
NCT07192302
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-25
First Post:
2025-08-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Partial Rotator Cuff Injury Combined With Stiff Shoulder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002062', 'term': 'Bursitis'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001182', 'term': 'Arthroscopy'}, {'id': 'D000280', 'term': 'Administration, Inhalation'}], 'ancestors': [{'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019637', 'term': 'Orthopedic Procedures'}, {'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-17', 'studyFirstSubmitDate': '2025-08-31', 'studyFirstSubmitQcDate': '2025-09-17', 'lastUpdatePostDateStruct': {'date': '2025-09-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Score', 'timeFrame': '6 months before surgery and 6 months after surgery', 'description': 'American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Score (ASES) scores from 0-100. The higher the number, the better the functional outcomes of the patients.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rotator Cuff Tears of the Shoulder', 'Shoulder Adhesive Capsulitis', 'Shoulder Arthroscopy']}, 'descriptionModule': {'briefSummary': 'A Randomized Controlled Trial Comparing Early Surgical Intervention Versus a Structured Rehabilitation Program with Delayed Surgery if Needed for Partial-Thickness Rotator Cuff Tears with Concomitant Shoulder Stiffness: The SPIRIT Trial (Surgery for Partial Tears with Immobility Randomized Intervention Trial)', 'detailedDescription': 'Objective: To compare the clinical and functional outcomes of early surgical intervention (arthroscopic debridement/repair and capsular release) versus an initial structured, supervised rehabilitation program with delayed surgery only for non-responders, in patients with PTRCT and shoulder stiffness.\n\nMethods: This will be a single-center, prospective, randomized, controlled, parallel-group trial. patients will be randomized (1:1) to either:\n\nGroup A (Early Surgery): Arthroscopic surgery within 6 weeks of randomization.\n\nGroup B (Rehabilitation-First): A 6-month structured physical therapy program. Patients who do not achieve a pre-defined successful outcome at 6 months will then undergo delayed surgery.\n\nPrimary outcome will be the change in the American Shoulder and Elbow Surgeons (ASES) Standardized Shoulder Assessment Score from baseline to 12 months. Secondary outcomes include pain (VAS), range of motion (ROM), Constant-Murley Score, Single Assessment Numeric Evaluation (SANE), and rates of conversion to surgery. Outcomes will be assessed at baseline 6 months and 6 months after surgery.\n\nExpected Outcomes: The investigators hypothesize that the early surgery group will demonstrate faster initial improvement in pain and function. However, the investigators anticipate that by 6 months, a significant proportion of the rehabilitation-first group will avoid surgery altogether and achieve non-inferior, if not equivalent, outcomes compared to the early surgery group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 18-80 years.\n2. Symptomatic shoulder pain for \\>2 weeks.\n3. MRI-confirmed partial-thickness rotator cuff tear (\\>50% tendon thickness or \\>5mm in length).\n4. Concomitant shoulder stiffness, defined as passive range of motion loss of ≥25% in at least two planes (forward flexion, abduction, external rotation, or internal rotation) compared to the contralateral side.\n5. Failure of a brief (≥2 weeks) trial of conservative care (e.g., oral NSAIDs).\n\nExclusion Criteria:\n\n1. Age\\< 18 or \\>80 years.\n2. Full-thickness rotator cuff tear.\n3. Previous surgery on the affected shoulder.\n4. Glenohumeral osteoarthritis (Grade ≥2 Samilson-Prieto).\n5. Cervical radiculopathy as a primary cause of symptoms.\n6. Systemic inflammatory arthritis.\n7. Neurologic disorder affecting the shoulder.\n8. Contraindications to surgery or general anesthesia.\n9. Inability to comply with the rehabilitation protocol.'}, 'identificationModule': {'nctId': 'NCT07192302', 'briefTitle': 'Partial Rotator Cuff Injury Combined With Stiff Shoulder', 'organization': {'class': 'OTHER', 'fullName': 'Hebei Medical University Third Hospital'}, 'officialTitle': 'the Treatment Strategy of Partial Rotator Cuff Injury in Stiff Shoulders', 'orgStudyIdInfo': {'id': 'GJL20250831'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A (Early Surgery)', 'description': ': Arthroscopic surgery within 6 weeks', 'interventionNames': ['Procedure: Arthroscopy']}, {'type': 'SHAM_COMPARATOR', 'label': 'Group B (Rehabilitation-First)', 'description': '6-month structured physical therapy program. Patients who do not achieve a pre-defined successful outcome at 6 months will then undergo delayed surgery.', 'interventionNames': ['Drug: Drugs administration']}], 'interventions': [{'name': 'Arthroscopy', 'type': 'PROCEDURE', 'description': 'Early Surgical Intervention in Patients with Partial Rotator Cuff Tears and Concomitant Shoulder Stiffness.', 'armGroupLabels': ['Group A (Early Surgery)']}, {'name': 'Drugs administration', 'type': 'DRUG', 'description': 'Oral Medication for Conservative Management of Partial Rotator Cuff Tears with Concomitant Shoulder Stiffness.', 'armGroupLabels': ['Group B (Rehabilitation-First)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '050000', 'city': 'Shijiazhuang', 'state': 'Hebei', 'country': 'China', 'facility': 'Jialiang Guo', 'geoPoint': {'lat': 38.04139, 'lon': 114.47861}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hebei Medical University Third Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}