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

Primary Purpose

Rotator Cuff Tears

Status
Not yet recruiting
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Celecoxib+Buprenorphine Transdermal Patch
Celecoxib+Buprenorphine Transdermal Patch+Tizanidine
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rotator Cuff Tears

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Drug: Celecoxib+Buprenorphine Transdermal Patch

    Drug: Celecoxib+Buprenorphine Transdermal Patch+Tizanidine

    Arm Description

    Outcomes

    Primary Outcome Measures

    Pittsburgh sleep quality index;PSQI

    Secondary Outcome Measures

    American Shoulder and Elbow Surgeons Score; ASES
    UCLA score; UCLA
    Visual Analogu Scale; VAS
    Oxford Shoulder Score; OSS

    Full Information

    First Posted
    May 2, 2023
    Last Updated
    May 2, 2023
    Sponsor
    Second Affiliated Hospital, School of Medicine, Zhejiang University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05852093
    Brief Title
    Clinical Study on the Effect of Tizanidine on the Function and Pain of Patients After Shoulder Arthroscopy
    Official Title
    Clinical Study on the Effect of Tizanidine on the Function and Pain of Patients After Shoulder Arthroscopy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 1, 2023 (Anticipated)
    Primary Completion Date
    June 1, 2026 (Anticipated)
    Study Completion Date
    June 1, 2027 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Second Affiliated Hospital, School of Medicine, Zhejiang University

    4. Oversight

    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
    Data Monitoring Committee
    No

    5. Study Description

    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;

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Rotator Cuff Tears

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Early Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Drug: Celecoxib+Buprenorphine Transdermal Patch
    Arm Type
    Active Comparator
    Arm Title
    Drug: Celecoxib+Buprenorphine Transdermal Patch+Tizanidine
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Celecoxib+Buprenorphine Transdermal Patch
    Intervention Description
    NSAIDs+narcotic analgesics
    Intervention Type
    Drug
    Intervention Name(s)
    Celecoxib+Buprenorphine Transdermal Patch+Tizanidine
    Intervention Description
    NSAIDs+narcotic analgesics+Skeletal Muscle Relaxant
    Primary Outcome Measure Information:
    Title
    Pittsburgh sleep quality index;PSQI
    Time Frame
    From Week 0 (baseline) to Week24
    Secondary Outcome Measure Information:
    Title
    American Shoulder and Elbow Surgeons Score; ASES
    Time Frame
    From Week 0 (baseline) to Week24
    Title
    UCLA score; UCLA
    Time Frame
    From Week 0 (baseline) to Week24
    Title
    Visual Analogu Scale; VAS
    Time Frame
    From Week 0 (baseline) to Week24
    Title
    Oxford Shoulder Score; OSS
    Time Frame
    From Week 0 (baseline) to Week24

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Guang Yang
    Phone
    13738097781
    Email
    2316426@zju.edu.cn

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes

    Learn more about this trial

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

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