Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT05852093

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;

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Celecoxib+Buprenorphine Transdermal Patch

Drug

NSAIDs+narcotic analgesics

Celecoxib+Buprenorphine Transdermal Patch+Tizanidine

Drug

NSAIDs+narcotic analgesics+Skeletal Muscle Relaxant

Primary outcomes

  1. Pittsburgh sleep quality index;PSQI

    Time frame: From Week 0 (baseline) to Week24

Secondary outcomes

  1. American Shoulder and Elbow Surgeons Score; ASES

    Time frame: From Week 0 (baseline) to Week24

  2. UCLA score; UCLA

    Time frame: From Week 0 (baseline) to Week24

  3. Visual Analogu Scale; VAS

    Time frame: From Week 0 (baseline) to Week24

  4. Oxford Shoulder Score; OSS

    Time frame: From Week 0 (baseline) to Week24

Study contacts

Contact information is provided by the study sponsor or research team.

Guang Yang

CONTACT

[email protected]

13738097781

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
May 10, 2023
Registry last updated
May 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.