NCT06041282招募中不适用
A Multicentre Randomized Controlled Trial of Manipulation Under Anesthesia and Supervised Home Rehabilitation in the Treatment of Early Adhesive Capsulitis
Second Affiliated Hospital, School of Medicine, Zhejiang University1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2026年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Constant-Murley Score (CMS)
研究概览
简要总结
A prospective, multicentre, randomized controlled study comparing the efficacy of conservative treatment for early adhesive capsulitis
详细描述
This clinical trial evaluated the most common protocols for the treatment of adhesive capsulitis in secondary hospitals. To compare the efficacy of manipulation under anesthesia and supervised home conservative treatment of early adhesive capsulitis.
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
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients in our hospital who need manual release of periarthritis of shoulder or home rehabilitation treatment;
- •Unilateral and primary periarthritis of shoulder
- •Age ≥40 years old and ≤80 years old, regardless of gender.
- •Forward flexion movement is more than 50% limited compared with the contralateral.
- •Duration of disease ≤3 months
排除标准
- •Patients with a previous history of shoulder joint surgery
- •Patients who did not complete the follow-up within the specified time
- •Patients with other shoulder diseases.
- •Patient with systemic immune disease.
- •Patients who have participated in clinical trials or are conducting other clinical trials within 3 months before screening
- •Patients with serious primary cardiovascular diseases, lung diseases, endocrine and metabolic diseases, or serious diseases affecting their survival, such as tumor or AIDS, are considered not suitable for admission.
- •Patients with serious liver diseases, kidney diseases, hematological diseases, such as kidney function (BUN, Cr) more than the upper limit of normal, liver function (ALT, AST, TBIL) more than 2 times the upper limit of normal.
- •Patients with viral hepatitis, infectious diseases, abnormal blood coagulation mechanism and other diseases that researchers consider inappropriate for surgery.
- •Pregnant or lactating women, or those planning to get pregnant during the test, with positive urine HCG test results before the test; Menstruating women should wait until their period is over before undergoing surgery.
- •Patients with severe neurological and mental diseases.
- •Suspected or true history of alcohol and drug abuse.
结局指标
主要结局
Constant-Murley Score (CMS)
时间窗: 6months after intervention
The Constant-Mulery score mainly includes 8 aspects related to your shoulder in the past 4 weeks. The proportion of subjective and objective components in the Constant-Mulery score is 35 points/65 points. A total of 100 points.The subjective part of the score includes the score of pain degree and the score of impact on daily life. 35 points in total.The objective part of the score includes the score of shoulder range of motion and strength. 65 points in total.
次要结局
- Constant-Murley Score (CMS)(1 months, 3months, and 1year after intervention)
- Oxford Shoulder Score (OSS)(1 months, 3months, 6 months and 1year after intervention)
- SF-36(1 months, 3months, 6 months and 1year after intervention)
- Visual analogue scale(VAS)(1 months, 3months, 6 months and 1year after intervention)
- Fear-avoidance belief questionnaire(FABQ)(1 months, 3months, 6 months and 1year after intervention)
- Insomnia Severity Index(ISI)(1 months, 3months, 6 months and 1year after intervention)
- Hospital Anxiety and Depression Scale(HADS)(1 months, 3months, 6 months and 1year after intervention)
- range of motion(1 months, 3months, 6 months and 1year after intervention)
研究者
研究点 (1)
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