Effects of Electroacupuncture to Relieve Itching Degree in Patients With Chronic Atopic Eczema

Not Applicable

Not yet recruiting

• Conditions: Chronic Lichenified Atopic Dermatitis

• Registration Number: NCT05529836
• Lead Sponsor: Shanghai Yueyang Integrated Medicine Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2022-08-27
• Status Verified: 2022-09
• Study First Submitted QC: 2022-09-03
• Last Update Submitted: 2022-09-03
• Study First Posted: 2022-09-07
• Last Update Posted: 2022-09-07
• Study Start: 2022-09-30
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 126

Inclusion Criteria

1. Meeting the TCM syndrome differentiation criteria and Western medicine diagnostic criteria for chronic eczema;
2. between the ages of 18 and 65;
3. BSA score < 10%;
4. Agree to participate in clinical trial observation and cooperate with regular visitors;
5. Sign and date the informed consent;

Exclusion Criteria

1. Patients who have been systematically treated with hormones or immunosuppressants within two weeks;
2. Recipients who are not durable to acupuncture;
3. Patients with severe secondary infection symptoms, including local skin infection and systemic infection of other organs;
4. Women who are pregnant, breastfeeding or planning to become pregnant during the trial;
5. Diabetes mellitus or patients with severe heart, liver and kidney disease;
6. Those who have received other research drugs or participated in other clinical trials within 3 months;
7. Unable to cooperate with the research for any reason, such as: language comprehension, unable to go to the research center for treatment, etc.;
8. Patients with generalized eczema, skin lesions all over the body and inconvenient for acupuncture;
9. Acute onset of chronic eczema.
10. BSA score ≥10%.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
the change from baseline in Visual Analogue Scale (VAS) scores	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.

Secondary Outcome Measures

Name	Time	Method
Eczema Area and Severity Index, EASI	week0, week1, week2
Dermatology Life Quality Index, DLQI	week1, week2	This index in the form of questionnaire, extent into very serious, serious, mild, not four grades, including skin have itch pain, skin problems due to the bad mood, affect normal life dating movement, cause inconvenience in daily life, such as problems, first by the clinic doctors to explain the survey on the patients, and then by patients according to the different problem corresponding to their own situation, Check the box in different degrees to complete the questionnaire independently.
Serum total IgE	week1, week2