Clinical Study on the Effect of Tizanidine on the Function and Pain of Patients After Shoulder Arthroscopy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Celecoxib+Buprenorphine Transdermal Patch, Celecoxib+Buprenorphine Transdermal Patch+Tizanidine.
- Who it may be relevant to
- Registry conditions: Rotator Cuff Tears. Basic parameters: 20 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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;
Interventions
- Drug Celecoxib+Buprenorphine Transdermal Patch
NSAIDs+narcotic analgesics - Drug Celecoxib+Buprenorphine Transdermal Patch+Tizanidine
NSAIDs+narcotic analgesics+Skeletal Muscle Relaxant
Primary outcome measures
- Pittsburgh sleep quality index；PSQI [Time frame: From Week 0 (baseline) to Week24]
Secondary outcome measures (4)
- American Shoulder and Elbow Surgeons Score; ASES [Time frame: From Week 0 (baseline) to Week24]
- UCLA score; UCLA [Time frame: From Week 0 (baseline) to Week24]
- Visual Analogu Scale; VAS [Time frame: From Week 0 (baseline) to Week24]
- Oxford Shoulder Score; OSS [Time frame: From Week 0 (baseline) to Week24]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT05852093 · 研2023-0251