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

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

Status
Not yet recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05852093
Enrollment
100
Registered
2023-05-10
Start date
2023-06-01
Completion date
2027-06-01
Last updated
2023-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rotator Cuff Tears

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;

Interventions

DRUGCelecoxib+Buprenorphine Transdermal Patch

NSAIDs+narcotic analgesics

DRUGCelecoxib+Buprenorphine Transdermal Patch+Tizanidine

NSAIDs+narcotic analgesics+Skeletal Muscle Relaxant

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Pittsburgh sleep quality index;PSQIFrom Week 0 (baseline) to Week24

Secondary

MeasureTime frame
American Shoulder and Elbow Surgeons Score; ASESFrom Week 0 (baseline) to Week24
UCLA score; UCLAFrom Week 0 (baseline) to Week24
Visual Analogu Scale; VASFrom Week 0 (baseline) to Week24
Oxford Shoulder Score; OSSFrom Week 0 (baseline) to Week24

Contacts

Primary ContactGuang Yang
2316426@zju.edu.cn13738097781

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026