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

NCT ID: NCT05852093

Last Updated: 2023-05-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-01

Study Completion Date

2027-06-01

Brief Summary

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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;

Detailed Description

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Conditions

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Rotator Cuff Tears

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Drug: Celecoxib+Buprenorphine Transdermal Patch

Group Type ACTIVE_COMPARATOR

Celecoxib+Buprenorphine Transdermal Patch

Intervention Type DRUG

NSAIDs+narcotic analgesics

Drug: Celecoxib+Buprenorphine Transdermal Patch+Tizanidine

Group Type EXPERIMENTAL

Celecoxib+Buprenorphine Transdermal Patch+Tizanidine

Intervention Type DRUG

NSAIDs+narcotic analgesics+Skeletal Muscle Relaxant

Interventions

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Celecoxib+Buprenorphine Transdermal Patch

NSAIDs+narcotic analgesics

Intervention Type DRUG

Celecoxib+Buprenorphine Transdermal Patch+Tizanidine

NSAIDs+narcotic analgesics+Skeletal Muscle Relaxant

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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YangGuang

Deputy chief doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Guang Yang

Role: CONTACT

13738097781

Other Identifiers

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研2023-0251

Identifier Type: -

Identifier Source: org_study_id

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