NCT03625050已完成2 期
Efficacy and Safety of Chuna Manual Treatment as an Adjunctive Therapy After Total Knee Arthroplasty: A Study Protocol for a Single-Center, Randomized, Assessor Blind, Parallel-Group Clinical Trial
Gachon University Gil Oriental Medical Hospital1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2018年11月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Change from baseline K-WOMAC score at week 4
研究概览
简要总结
Evaluate the efficacy and safety of Chuna treatment as an adjunctive therapy in patients with moderate pain following total knee replacement.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with NRS of knee pain ≥4 during the 7 days after 3 months total knee replacement
- •Patients who have agreed to trial participation and provided written informed consent
排除标准
- •Those who have been diagnosed with certain serious diseases that can cause knee pain. : tumor, infectious or inflammatory disease, etc.
- •Those taking analgesics for the purpose of relieving pain, fever and inflammation within 7 days
- •Those with progressive neurological deficits or with severe neurological symptoms
- •Those who have other chronic conditions that may interfere with the interpretation of treatment effects or outcomes : Cardiovascular disease, kidney disease, diabetic neuropathy, dementia, epilepsy, etc.
- •Those who are not fit or unsafe to chuna therapy: clotting disorders, Those receiving anticoagulant therapy, Severe diabetes patients who are at risk of infection, severe cardiovascular disease
- •Those who are participating in other clinical trials
- •Those who have a history of participating in other clinical trials within one month
- •Those who are difficult to write a research consent form
- •Those who are judged to be inappropriate for the clinical study by the researchers.
研究组 & 干预措施
Chuna + Usual care
Experimental
干预措施: Chuna + Usual care(Celecoxib and esomeprazole) (Procedure)
Usual care
Active Comparator
干预措施: Usual care(Celecoxib and esomeprazole) (Drug)
结局指标
主要结局
Change from baseline K-WOMAC score at week 4
时间窗: Week 0, Week 4
Assess the recovery of knee function
次要结局
- Change from baseline K-WOMAC score at every visit(Week 0, Week 2, Week 4, Week 8)
- Change from baseline EQ-5D score at every visit(Week 0, Week 2, Week 4, Week 8)
- Change from baseline in Range of motion score at every visit(Week 0, Week 2, Week 4, Week 8)
- Change from baseline Numeric rating scale score at every visit(Week 0, Week 2, Week 4, Week 8)
- Change from baseline in Timed Up and Go Test at every visit(Week 0, Week 2, Week 4, Week 8, Week 12)
- Difference between the EuroQol Visual Analogue Scale (EQ-VAS) at each timepoint and baseline, respectively(Week 0, Week 2, Week 4, Week 8)
- Change from baseline in Alternative-Step Test at every visit(Week 0, Week 2, Week 4, Week 8, Week 12)
- Change from baseline in Physical Condition related with mobility at every visit(Week 0, Week 2, Week 4, Week 8, Week 12)
- Change from baseline in Physical Condition related with endurance at every visit(Week 0, Week 2, Week 4, Week 8, Week 12)
- Cost per QALY(Quality Adjusted Life Years) gained(Week 0, Week 4, Week 8, Week 12)
研究者
Yun-Kyung Song
Sponsor-principle investigator
Gachon University Gil Oriental Medical Hospital
研究点 (1)
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