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

NCT05852093 | Not Yet Recruiting Early Phase 1

• 1 other identifier: 研2023-0251
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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;

Conditions

Rotator Cuff Tears

Outcome Measures

Primary Outcomes (1)

• Pittsburgh sleep quality index；PSQI

  From Week 0 (baseline) to Week24

Secondary Outcomes (4)

• 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

Study Arms (2)

Drug: Celecoxib+Buprenorphine Transdermal Patch

ACTIVE COMPARATOR

Drug: Celecoxib+Buprenorphine Transdermal Patch

Drug: Celecoxib+Buprenorphine Transdermal Patch+Tizanidine

EXPERIMENTAL

Drug: Celecoxib+Buprenorphine Transdermal Patch+Tizanidine

Interventions

Celecoxib+Buprenorphine Transdermal Patch DRUG

NSAIDs+narcotic analgesics

Drug: Celecoxib+Buprenorphine Transdermal Patch

Celecoxib+Buprenorphine Transdermal Patch+Tizanidine DRUG

NSAIDs+narcotic analgesics+Skeletal Muscle Relaxant

Drug: Celecoxib+Buprenorphine Transdermal Patch+Tizanidine

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Central Study Contacts

Guang Yang

CONTACT

13738097781; 2316426@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy chief doctor

Study Record Dates

• First Submitted: May 2, 2023
• First Posted: May 10, 2023
• Study Start: June 1, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: May 10, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share