Clinical Study on the Effect of Tizanidine on the Function and Pain of Patients After Shoulder Arthroscopy

Early Phase 1

Not yet recruiting

• Conditions: Rotator Cuff Tears
• Interventions: Drug: Celecoxib+Buprenorphine Transdermal Patch; Drug: Celecoxib+Buprenorphine Transdermal Patch+Tizanidine

• Registration Number: NCT05852093
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief Summary

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;

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-05
• Study First Submitted: 2023-05-02
• Study First Submitted QC: 2023-05-02
• Last Update Submitted: 2023-05-02
• Study First Posted: 2023-05-10
• Last Update Posted: 2023-05-10
• Study Start: 2023-06-01
• Primary Completion: 2026-06-01
• Study Completion: 2027-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1 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

Exclusion Criteria

1. Patients with simple frozen shoulder;
2. Patients with shoulder joint tuberculosis, gout, tumor, rheumatoid disease or infectious disease; 3. There are other joint pain factors before operation;

4 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Drug: Celecoxib+Buprenorphine Transdermal Patch	Celecoxib+Buprenorphine Transdermal Patch	-
Drug: Celecoxib+Buprenorphine Transdermal Patch+Tizanidine	Celecoxib+Buprenorphine Transdermal Patch+Tizanidine	-

Primary Outcome Measures

Name	Time	Method
Pittsburgh sleep quality index；PSQI	From Week 0 (baseline) to Week24

Secondary Outcome Measures

Name	Time	Method
UCLA score; UCLA	From Week 0 (baseline) to Week24
Visual Analogu Scale; VAS	From Week 0 (baseline) to Week24
American Shoulder and Elbow Surgeons Score; ASES	From Week 0 (baseline) to Week24
Oxford Shoulder Score; OSS	From Week 0 (baseline) to Week24