Effects of Electroacupuncture to Relieve Itching Degree in Patients With Chronic Atopic Eczema: Study Protocol for a Randomized Multicenter, Sham Electroacupuncture, Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 126
- 主要终点
- the change from baseline in Visual Analogue Scale (VAS) scores
研究概览
简要总结
Eczema is a common allergic skin disease, accounting for about 15 to 30% of dermatological outpatients. Pruritus as one of the most painful symptoms is often underestimated in terms of the problems that it can cause, which creates the vicious loop of itching, scratching, and lichenification. Therefore, further research into practical and safe treatments that eliminate itchy symptoms and enhance skin protection is the key to overcoming chronic atopic eczema. Acupuncture has been utilized clinically in China for thousands of years due to its benefits of being practical, affordable, and simple to execute. With modern science and technology advancements, electroacupuncture (AE) has become widely used in China's public hospitals to treat chronic atopic eczema. This trial aims to objectively evaluate the clinical efficacy and safety of the electroacupuncture antipruritic technique in chronic atopic eczema pruritus and to obtain its high-level clinical evidence for the popularization and application of electroacupuncture clinical treatment of chronic atopic eczema.
详细描述
As a common allergic skin disease, the incidence of eczema is increasing year by year, accounting for about 15 ~ 30% of the dermatological outpatients. Pruritus is one of the most painful symptoms of eczema. Patients often form a vicious circle of "pruritus -- scratching -- mossy transformation" because they can't stand it. Research on safe and effective anti-pruritus program has become the key to treatment. Inheriting the experience of Xia's surgery in Shanghai, the team proposed the core pathogenesis of "blood heat and dampness heat", formulated the treatment principle of "cooling blood dehumidification", selected acupoints Quchi (LI4), Hegu (LI11), Xuehai (SP10) and Sanyi jiao (SP6), and used the original acupuncture anti-pruritus technique (modified by acupuncture anesthesia technique) to treat chronic eczema with clinical advantages. Small sample Pilot study showed that acupuncture antipruritic technique significantly reduced the visual analogue scale (VAS) score of patients with chronic eczema, which was significantly better than sham EA group and non-EA group. This project adopts the multicenter, randomized, including false contrast design, objective, normative evaluation of acupuncture for chronic eczema itching itching and technology to improve situation, clinical efficacy and safety, obtain exact clinical evidence, further to form suitable for standardization, popularization and application in wide range of chronic eczema itching technology clinical acupuncture specification.
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 (Participant)
盲法说明
To ensure blinding, we will choose the Park Sham Device (PSD) as a placebo control in the single-blind clinical trial, use a way of not energizing the electroacupuncture device, and use black eye masks to shield participants' eyes. The treatment device will also be of the same size and material, and the treatment method will maintain consistent frequency and intensity.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meeting the TCM syndrome differentiation criteria and Western medicine diagnostic criteria for chronic eczema;
- •between the ages of 18 and 65;
- •BSA score < 10%;
- •Agree to participate in clinical trial observation and cooperate with regular visitors;
- •Sign and date the informed consent;
排除标准
- •Patients who have been systematically treated with hormones or immunosuppressants within two weeks;
- •Recipients who are not durable to acupuncture;
- •Patients with severe secondary infection symptoms, including local skin infection and systemic infection of other organs;
- •Women who are pregnant, breastfeeding or planning to become pregnant during the trial;
- •Diabetes mellitus or patients with severe heart, liver and kidney disease;
- •Those who have received other research drugs or participated in other clinical trials within 3 months;
- •Unable to cooperate with the research for any reason, such as: language comprehension, unable to go to the research center for treatment, etc.;
- •Patients with generalized eczema, skin lesions all over the body and inconvenient for acupuncture;
- •Acute onset of chronic eczema.
- •BSA score ≥10%.
结局指标
主要结局
the change from baseline in Visual Analogue Scale (VAS) scores
时间窗: week0, week1, week2
Pruritus, as the main clinical symptom of eczema, can be scored separately as follows: Pruritus score standard: no pruritus =0; mild（Itchy, not scratching, not affecting daily life) = 1-3 points; Moderate (frequent pruritus, occasional scratching, affecting daily life and sleep) = 4-6 points; Severe (severe itching, frequent scratching, seriously affecting daily life and sleep) = 7-10 points.
次要结局
- Eczema Area and Severity Index, EASI(week0, week1, week2)
- Dermatology Life Quality Index, DLQI(week1, week2)
- Serum total IgE(week1, week2)