Antipruritic Effect of Acupuncture in Patients With Atopic Dermatitis: Feasibility Study Protocol for a Randomised, Sham-Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Itch VAS
研究概览
简要总结
Introduction: Atopic dermatitis (AD) is a chronic relapsing inflammatory skin disease inducing poor quality of life. Its conventional treatments often cause unsatisfactory relief and adverse effects in long-term application. Acupuncture treatment is regarded to have a curative effect on AD symptoms. The aim of this trial is to evaluate the therapeutic effects of acupuncture on AD symptoms including pruritus and poor quality of life in patients with AD.
Method and Analysis: This trial is a randomized, sham-controlled pilot trial with different visit frequencies. 30 eligible patients with atopic dermatitis will be randomly allocated in a ratio of 1:1:1 to the Verum Acupuncture group 1 (VA1, 3 days weekly), Verum Acupuncture group 2 (VA2, 2 days weekly) and Sham Acupuncture group (2 days weekly). The acupuncture treatment will be given three or two times a week for 4 weeks according to the allocated groups. The main outcome measures are Visual analogue scale for itch (itch VAS), SCORing Atopic Dermatitis (SCORAD) and Eczema Area and Severity Index (EASI) to evaluate the improvement of AD symptoms and Patient Oriented Eczema Measure (POEM), Dermatology Life Quality Index (DLQI) to assess the quality of life of AD patients. It will be measured at baseline, once a week during treatment period and after follow-up period.
Ethics/Dissemination: This protocol was approved by the Institutional Review Boards at Kyung Hee University Korean Medicine Hospital on May 2016. The permission number is KOMCIRB-160212-HRBR-004. This trial will provide the data of therapeutic effects of treating atopic dermatitis with acupuncture in accordance with the different visit frequencies. The outcomes will be facilitated to calculate the sample size of further study with the same design of this study. The findings from this trial will be published and presented in conference.
详细描述
Objectives This pilot study aims to investigate the feasibility of validating the anti-pruritic effectiveness of the sole acupuncture intervention and the efficacy of different frequent treatments of acupuncture, and discovering noble candidates of a specific biomaterial associated with the development of atopic dermatitis. Moreover, the result will be facilitated in calculating the sample size on the further study.
Trial design A randomized, sham-controlled, different intervention frequency trial will be conducted at the Kyung Hee University Korean Medicine Hospital from June to November 2016.
Participants and Recruitment
Recruitment Acquiring consent will be conducted by the investigators with the principle of informed consent which confirms participants' voluntarism. The participants will sign the document made of general consent form and additional consent provisions for blood collection and use of their human derived material first of all. The exemplary consent paper and other related literature can be offered upon request.
Randomization and allocation concealment The AD patients will be randomized to one of the three groups via block randomization.
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)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals over age 19
- •Individuals who meet the Hanifin & Rajka and whose AD symptoms express constantly
- •Individuals who check more than 3 points and less than 8 points on the visual analogue scale for atopic dermatitis (with a total score out of 10)
- •Individuals who are graded 10 to 40 points on the SCORAD index
- •Individuals who have not taken the subscribed medicines for atopic dermatitis recent one month.
- •Individuals who understand this study protocol and voluntarily agree with participation.
- •Individuals who have not participated any other researches recent one month
排除标准
- •Individuals whose modalities of atopic dermatitis change unpredictably
- •Individuals who receive inappropriate therapies such as oral corticosteroids which affect the outcomes
- •Individuals who also have asthma, bronchitis or other sever psychological disorders
- •Individuals who have other inappropriate disorders affecting the outcomes
研究组 & 干预措施
Verum Acupuncture 1
The participants with atopic dermatitis in the acupuncture group 1 will attend twelve acupuncture sessions over 4 weeks: 3 days a week. Once the 4-week treatment period was ended, the additional follow-up period will be conducted. The subjects will stand a final visit 4 weeks from the end of treatment period. Any other intervention will not be allowed during this study period.
干预措施: Acupuncture (Device)
Verum Acupuncture 2
The participants with atopic dermatitis in the acupuncture group 2 will attend eight acupuncture sessions over 4 weeks: 2 days a week. Once the 4-week treatment period was ended, the additional follow-up period will be conducted. The subjects will stand a final visit 4 weeks from the end of treatment period. Any other intervention will not be allowed during this study period.
干预措施: Acupuncture (Device)
Sham Acupuncture
The participants in the sham acupuncture group will visit eight acupuncture sessions over 4 weeks. The acupuncture treatment will be conducted on six control points. The acupressure will be applied with ring-sham press tack needles on three control points. Unlike the acupuncture group 2, partially-individualized manual acupuncture according to the patient's symptoms will not be given but the questions about symptoms will be questioned to patients.
干预措施: Sham Acupuncture (Device)
Healthy Control
The participants will go through the screening test. The included subjects will complete questionnaires and their blood sample will be obtained.
结局指标
主要结局
Itch VAS
时间窗: Baseline, 1-week, 2-week, 3-week, 4-week, and 8-week
The itch VAS is one of components of SCORAD index, and it will be particularly applied to assess the severity and alleviation of atopic dermatitis in this trial. The AD patients whose itch VAS scores less than 30 or more than 80 will be excluded because of their lower desire for anti-pruritic therapy or requirement of more potent treatment 13. The change of itch VAS through the trial will be used to classify as responders or non-responders of the acupuncture treatment.
SCORAD index
时间窗: Baseline, 1-week, 2-week, 3-week, 4-week, and 8-week
SCORAD is a well-known tool for assessing the severity of atopic dermatitis. The SCORAD contains evaluation of the intensity and extent of affected region and estimation of subjective discomforts, such as pruritus and sleep loss symptom 10-12. SCORAD index contains 6 items to evaluate intensity of atopic dermatitis: erythema, exoriation, edema or papulation, lichenification, oozing or crust, and dryness. The extent of lesion is assessed as percentage of entity. One same KMD will grade the intensity and extent of affected skin and a patient will check their subjective symptoms with visual analogue scale (0 = no itch or sleep loss, 10 = worst imaginable itch or sleep loss). The change from baseline SCORAD index at 4 weeks will be analyzed as the primary outcome measure.
EASI score
时间窗: Baseline, 1-week, 2-week, 3-week, 4-week, and 8-week
EASI is a validated instrument measuring the severity of atopic dermatitis 12 14. It is composed of distribution of four body regions and four signs of AD: head and neck, trunk, upper extremities, and lower extremities for body regions and erythema, edema/papulation, excoriation, and lichenification for signs of atopic dermatitis. One same KMD will grade the severity of atopic dermatitis with EASI score. The change from baseline EASI score at 4 weeks will be analyzed as the primary outcome measure.
次要结局
- POEM(Baseline, 1-week, 2-week, 3-week, 4-week, and 8-week)
- DLQI(Baseline, 1-week, 2-week, 3-week, 4-week, and 8-week)
研究者
Kyuseok Kim
assistant professor
Kyunghee University