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

May 2, 2023 updated by: YangGuang, Second Affiliated Hospital, School of Medicine, Zhejiang University
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

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: From Week 0 (baseline) to Week24
From Week 0 (baseline) to Week24

Secondary Outcome Measures

Outcome Measure
Time Frame
American Shoulder and Elbow Surgeons Score; ASES
Time Frame: From Week 0 (baseline) to Week24
From Week 0 (baseline) to Week24
UCLA score; UCLA
Time Frame: From Week 0 (baseline) to Week24
From Week 0 (baseline) to Week24
Visual Analogu Scale; VAS
Time Frame: From Week 0 (baseline) to Week24
From Week 0 (baseline) to Week24
Oxford Shoulder Score; OSS
Time Frame: From Week 0 (baseline) to Week24
From Week 0 (baseline) to Week24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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