Ignite Creation Date:
2025-12-25 @ 1:05 AM
Ignite Modification Date:
2025-12-27 @ 3:18 AM
Study NCT ID:
NCT05852093
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-05-10
First Post:
2023-05-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Study on the Effect of Tizanidine on the Function and Pain of Patients After Shoulder Arthroscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070636', 'term': 'Rotator Cuff Injuries'}], 'ancestors': [{'id': 'D012421', 'term': 'Rupture'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D000070599', 'term': 'Shoulder Injuries'}, {'id': 'D013708', 'term': 'Tendon Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2027-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-02', 'studyFirstSubmitDate': '2023-05-02', 'studyFirstSubmitQcDate': '2023-05-02', 'lastUpdatePostDateStruct': {'date': '2023-05-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pittsburgh sleep quality index；PSQI', 'timeFrame': 'From Week 0 (baseline) to Week24'}], 'secondaryOutcomes': [{'measure': 'American Shoulder and Elbow Surgeons Score; ASES', 'timeFrame': 'From Week 0 (baseline) to Week24'}, {'measure': 'UCLA score; UCLA', 'timeFrame': 'From Week 0 (baseline) to Week24'}, {'measure': 'Visual Analogu Scale; VAS', 'timeFrame': 'From Week 0 (baseline) to Week24'}, {'measure': 'Oxford Shoulder Score; OSS', 'timeFrame': 'From Week 0 (baseline) to Week24'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rotator Cuff Tears']}, 'descriptionModule': {'briefSummary': 'The perspective, randomized controlled trial is to investigate and evaluate the effect of Tizanidine on the function and pain of patients with rotator cuff tear after shoulder arthroscopy;'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1 Patients who were diagnosed as supraspinatus tendon and infraspinatus tendon tear and underwent shoulder arthroscopic surgery in the Second Affiliated Hospital of Zhejiang University; 2 Age 20\\~70 years old; 3 Those with a long medical history, and symptoms such as shoulder joint pain and weakness in a short period of time are obviously aggravated; 4. After 3 months of medication and physical therapy, the symptoms and functions have not improved significantly; 5 Volunteer to participate in this study, and the person and his/her family members have given informed consent to the content of this study and signed the consent form\n\nExclusion Criteria:\n\n1. Patients with simple frozen shoulder;\n2. Patients with shoulder joint tuberculosis, gout, tumor, rheumatoid disease or infectious disease; 3. There are other joint pain factors before operation;\n\n4 Patients with subscapularis tendon tear, long head tendinopathy requiring surgical treatment, and severe shoulder synovitis were found during the operation; 5 Patients with upper limb nerve injury, shoulder fracture, bone defect or severe osteoporosis; 6. Patients with serious organ or hematopoietic system and other primary diseases; 7. Those who are allergic to the drugs used in this study; 8 Women who are breast-feeding, pregnant or preparing to become pregnant; 9 Patients with language and communication disorders, mental history, cognitive dysfunction, etc. who cannot cooperate with the completion of nursing intervention and research, and cannot complete the questionnaire required for this study.'}, 'identificationModule': {'nctId': 'NCT05852093', 'briefTitle': 'Clinical Study on the Effect of Tizanidine on the Function and Pain of Patients After Shoulder Arthroscopy', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}, 'officialTitle': 'Clinical Study on the Effect of Tizanidine on the Function and Pain of Patients After Shoulder Arthroscopy', 'orgStudyIdInfo': {'id': '研2023-0251'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Drug: Celecoxib+Buprenorphine Transdermal Patch', 'interventionNames': ['Drug: Celecoxib+Buprenorphine Transdermal Patch']}, {'type': 'EXPERIMENTAL', 'label': 'Drug: Celecoxib+Buprenorphine Transdermal Patch+Tizanidine', 'interventionNames': ['Drug: Celecoxib+Buprenorphine Transdermal Patch+Tizanidine']}], 'interventions': [{'name': 'Celecoxib+Buprenorphine Transdermal Patch', 'type': 'DRUG', 'description': 'NSAIDs+narcotic analgesics', 'armGroupLabels': ['Drug: Celecoxib+Buprenorphine Transdermal Patch']}, {'name': 'Celecoxib+Buprenorphine Transdermal Patch+Tizanidine', 'type': 'DRUG', 'description': 'NSAIDs+narcotic analgesics+Skeletal Muscle Relaxant', 'armGroupLabels': ['Drug: Celecoxib+Buprenorphine Transdermal Patch+Tizanidine']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Guang Yang', 'role': 'CONTACT', 'email': '2316426@zju.edu.cn', 'phone': '13738097781'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Deputy chief doctor', 'investigatorFullName': 'YangGuang', 'investigatorAffiliation': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}}}}