NCT05529836

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

Effects of Electroacupuncture to Relieve Itching Degree in Patients With Chronic Atopic Eczema: Study Protocol for a Randomized Multicenter, Sham Electroacupuncture, Clinical Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 126 (estimated)
• Sponsor: Shanghai Yueyang Integrated Medicine Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Lichenified Atopic Dermatitis

Interventions

Type	Name	Description
DEVICE	electroacupunture	The participants in EA group will receive acupuncture with PSD at bilateral Hegu (LI4), bilateral Quchi (LU5), bilateral Xuehai (SP10) and bilateral San Yinjiao (SP6). After skin disinfection, followed at an angle of 90°, acupuncture needles were inserted approximately 50 to 60 mm into the skin. When achieving qi, connect the four pairs of electrodes, two each on bilateral Quchi (LI4) and Hegu (LI11), two each on bilateral Xuehai (SP10) and San Yinjiao (SP6), and they are all ipsilateral to one another. The duration of the electroacupuncture stimulation is 30 minutes, and the current intensity ranges from 1 to 5 mA with a continuous wave of 20 Hz. For two weeks straight, the participants will have three therapy sessions each week (preferably every other day), for a total of six sessions.
DEVICE	sham electroacupuncture	Participants in the SEA group will receive sham electroacupuncture with PSD, but not energizing the electropuncture device. Procedures, electrode placements, and other treatment settings are the same as in the EA group but with no electricity output only.
DEVICE	sham acupuncture	Participants in the SAC group will receive sham acupuncture with PSD and PSN on sham acupoints (the non-meridian and non-acupuncture points). Procedures, electrode placements, and other treatment settings are the same as in the EA group but with no skin penetration, electricity output, or needle manipulation for achieving qi.

Timeline

• Start date: 2022-09-30
• Primary completion: 2025-06-30
• Completion: 2025-06-30
• First posted: 2022-09-07
• Last updated: 2022-09-07