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

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;

Study Overview

• Status: Not yet recruiting
• Conditions: Rotator Cuff Tears
• Intervention / Treatment: Drug: Celecoxib+Buprenorphine Transdermal Patch; Drug: Celecoxib+Buprenorphine Transdermal Patch+Tizanidine

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Guang Yang; Phone Number: 13738097781; Email: 2316426@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Drug: Celecoxib+Buprenorphine Transdermal Patch	Drug: Celecoxib+Buprenorphine Transdermal Patch; NSAIDs+narcotic analgesics
Experimental: Drug: Celecoxib+Buprenorphine Transdermal Patch+Tizanidine	Drug: Celecoxib+Buprenorphine Transdermal Patch+Tizanidine; NSAIDs+narcotic analgesics+Skeletal Muscle Relaxant

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2023
• Primary Completion (Anticipated): June 1, 2026
• Study Completion (Anticipated): June 1, 2027

Study Registration Dates

• First Submitted: May 2, 2023
• First Submitted That Met QC Criteria: May 2, 2023
• First Posted (Actual): May 10, 2023

Study Record Updates

• Last Update Posted (Actual): May 10, 2023
• Last Update Submitted That Met QC Criteria: May 2, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture; Shoulder Injuries; Tendon Injuries; Rotator Cuff Injuries; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Analgesics, Opioid; Narcotics; Narcotic Antagonists; Anticonvulsants; Cyclooxygenase 2 Inhibitors; Neuromuscular Agents; Muscle Relaxants, Central; Buprenorphine; Celecoxib; Tizanidine
• Other Study ID Numbers: 研2023-0251

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No