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

Study Overview
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Brief Summary
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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;

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

Conditions
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Rotator Cuff Tears

Intervention / Treatment
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* Drug: Celecoxib+Buprenorphine Transdermal Patch
* Drug: Celecoxib+Buprenorphine Transdermal Patch+Tizanidine


Participation Criteria
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Eligibility Criteria
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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: Patients with simple frozen shoulder; 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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Drug: Celecoxib+Buprenorphine Transdermal Patch<br> | Drug: Celecoxib+Buprenorphine Transdermal Patch<br>* NSAIDs+narcotic analgesics<br>|
| Experimental: Drug: Celecoxib+Buprenorphine Transdermal Patch+Tizanidine<br> | Drug: Celecoxib+Buprenorphine Transdermal Patch+Tizanidine<br>* NSAIDs+narcotic analgesics+Skeletal Muscle Relaxant<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pittsburgh sleep quality index；PSQI |  | From Week 0 (baseline) to Week24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| American Shoulder and Elbow Surgeons Score; ASES |  | From Week 0 (baseline) to Week24 | 
| UCLA score; UCLA |  | From Week 0 (baseline) to Week24 | 
| Visual Analogu Scale; VAS |  | From Week 0 (baseline) to Week24 | 
| Oxford Shoulder Score; OSS |  | From Week 0 (baseline) to Week24 |