Clinical Research on the Efficacy and Safety of Cettum on Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 发起方
- Eun Jung Kim
- 入组人数
- 138
- 试验地点
- 4
- 主要终点
- Pain NRS (Numeric Rating Scale) change
研究概览
简要总结
The purpose of this study is verify the efficacy and safety of Cettum (Electric moxibustion) for patients with knee osteoarthritis.
详细描述
The investigator targets the patients with knee osteoarthritis. After treatment in 3 groups - Cettum treatment, traditional indirect moxibustion treatment, and usual care groups - the investigators will compare the effects of pain relieving and daily performing improvement. So the investigators will confirm the efficacy of Cettum, and further the best treatment method. In addition, the investigators are going to evaluate the safety of abnormal reaction during the treatment.
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
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 40 years of age, but below 70 years of age
- •Presence of knee osteoarthritis diagnosed according to American College of Rheumatology classification criteria and satisfying the following 2 conditions
- •Knee pain when weight load in one or both knees in the last 6 months
- •Knee pain rated >4cm on a 10cm Visual Analog Scale (VAS)
- •Feeling temperature sense to distinguish temperature differences
- •An understanding of the objectives and methods of the clinical trial, and willingness in completing the consent form
- •Those who are reliable and willing to cooperate in this test, and obey the restrictions for the next 3 months
排除标准
- •Trauma to the knee(s) within 6 months prior to enrollment, causing pain or functional problems
- •Surgery on the knee(s) within 6 months prior to enrollment, causing pain or functional problems
- •A history of intra-articular injection within the last 3 months
- •A physical or laboratory finding indicating presence of an inflammatory arthritis (e.g. rheumatoid arthritis, autoimmune disease)
- •Presence of physical or psychiatric disorder that may affect moxibustion treatment
- •Presence of neurological disorder including paralysis symptoms on local or general sensation
- •A female who is pregnant or is lactating
- •Being afraid of moxibustion treatment or expected to cause side effects
- •When researchers evaluate that it is not appropriate to participate in this clinical test
研究组 & 干预措施
Cettum (Electric moxibustion)
The patients in this group receive Cettum (Electric moxibustion) treatment prescribed by a certified Korean Medicine Doctor with more than 6 years of Oriental Medicine College education.
干预措施: Cettum (Device)
Traditional indirect moxibustion
The patients in this group receive traditional indirect moxibustion treatment using the same points, applied by a certified Korean Medicine Doctor with more than 6 years of Oriental Medicine College education.
干预措施: Traditional indirect moxibustion (Procedure)
Usual care
The patients in this group maintain the usual treatment and self-care.
干预措施: Usual care (Other)
结局指标
主要结局
Pain NRS (Numeric Rating Scale) change
时间窗: 6 weeks
The Numeric Rating Scale is a unidimensional measure of pain intensity. The 11-point numeric scale ranges from '0' representing 'no pain' to '10' representing 'worst pain imaginable'.
次要结局
- 100mm Pain VAS (Visual Analogue Scale)(6 weeks)
- WOMAC (Western Ontario and McMaster Universities) total(6 weeks)
- EQ-5D-5L (EuroQol 5-Dimensions 5-Levels)(6 weeks)
- Temperature sense threshold(6 weeks)
- PGA (Patient Global Assessment)(6 weeks)
- Adverse Events(6 weeks)
研究者
Eun Jung Kim
Principle Investigator
DongGuk University