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

Rotator Cuff Tears Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05852093
• Other study ID #: ?2023-0251
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: June 1, 2023
• Est. completion date: June 1, 2027

Study information

• Verified date: May 2023
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Guang Yang
• Phone: 13738097781
• Email: 2316426[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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;

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: June 1, 2027
• Est. primary completion date: June 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Rotator Cuff Tears

Intervention

Drug:
• Celecoxib+Buprenorphine Transdermal Patch
NSAIDs+narcotic analgesics
• Celecoxib+Buprenorphine Transdermal Patch+Tizanidine
NSAIDs+narcotic analgesics+Skeletal Muscle Relaxant

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pittsburgh sleep quality index;PSQI		From Week 0 (baseline) to Week24
Secondary	American Shoulder and Elbow Surgeons Score; ASES		From Week 0 (baseline) to Week24
Secondary	UCLA score; UCLA		From Week 0 (baseline) to Week24
Secondary	Visual Analogu Scale; VAS		From Week 0 (baseline) to Week24
Secondary	Oxford Shoulder Score; OSS		From Week 0 (baseline) to Week24