NCT05852093尚未招募早期 1 期
Clinical Study on the Effect of Tizanidine on the Function and Pain of Patients After Shoulder Arthroscopy
Second Affiliated Hospital, School of Medicine, Zhejiang University0 个研究点目标入组 100 人开始时间: 2023年6月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 主要终点
- Pittsburgh sleep quality index；PSQI
研究概览
简要总结
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;
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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;
- •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
排除标准
- •Patients with simple frozen shoulder;
- •Patients with shoulder joint tuberculosis, gout, tumor, rheumatoid disease or infectious disease;
- •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;
- •Patients with serious organ or hematopoietic system and other primary diseases;
- •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.
研究组 & 干预措施
Drug: Celecoxib+Buprenorphine Transdermal Patch
Active Comparator
干预措施: Celecoxib+Buprenorphine Transdermal Patch (Drug)
Drug: Celecoxib+Buprenorphine Transdermal Patch+Tizanidine
Experimental
干预措施: Celecoxib+Buprenorphine Transdermal Patch+Tizanidine (Drug)
结局指标
主要结局
Pittsburgh sleep quality index；PSQI
时间窗: From Week 0 (baseline) to Week24
次要结局
- UCLA score; UCLA(From Week 0 (baseline) to Week24)
- Visual Analogu Scale; VAS(From Week 0 (baseline) to Week24)
- American Shoulder and Elbow Surgeons Score; ASES(From Week 0 (baseline) to Week24)
- Oxford Shoulder Score; OSS(From Week 0 (baseline) to Week24)
研究者
YangGuang
Deputy chief doctor
Second Affiliated Hospital, School of Medicine, Zhejiang University
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