Efficacy Evaluation of Electroacupuncture in the Treatment of Functional Dyspepsia

Summary

Functional dyspepsia (FD) is a common disorder that causes stomach discomfort, such as fullness or pain after eating, without any visible structural disease. Acupuncture is often used to manage these symptoms. This study aims to evaluate the safety and effectiveness of electroacupuncture-a form of acupuncture that uses gentle electrical stimulation-for treating functional dyspepsia. Specifically, the trial will compare the benefits of applying electroacupuncture to points on the abdomen (local points) versus points on the arms and legs (distal points), alongside a control group receiving a sham (inactive) treatment. The goal is to determine the most effective acupuncture strategy for improving patients' digestive symptoms and overall quality of life.

Conditions

• Functional Dyspepsia
• Electroacupuncture

Interventions

OTHER

Electroacupuncture (Local Acupoints)

Participants assigned to this intervention will receive electroacupuncture at local abdominal acupoints, including bilateral Shangwan (CV13), Zhongwan (CV12), Xiawan (CV10), Liangmen (ST21), and Tianshu (ST25). Sterile disposable acupuncture needles (0.30 × 40 mm) will be inserted vertically by licensed acupuncturists with at least three years of clinical experience to a depth of approximately 20-30 mm to elicit the Deqi sensation (such as soreness, numbness, distension, or heaviness). Two pairs of acupoints (Shangwan-Zhongwan and left Liangmen-right Liangmen) will be connected to an SDZ-V electroacupuncture device. Electrical stimulation will be applied at a frequency of 5 Hz, with current intensity adjusted to the participant's tolerance. Each treatment session will last 30 minutes and will be administered twice weekly for 3 weeks (6 sessions in total).

OTHER

Electroacupuncture (Distal Acupoints)

Participants in this group will receive electroacupuncture at distal limb acupoints, including bilateral Zusanli (ST36), Shangjuxu (ST37), Xiajuxu (ST39), and Yinlingquan (SP9). Sterile disposable acupuncture needles (0.30 × 40 mm) will be inserted by trained acupuncturists to achieve the Deqi sensation. Electrical stimulation will be applied by connecting bilateral Zusanli (ST36) and Xiajuxu (ST39) to an SDZ-V electroacupuncture device. The stimulation frequency will be set at 5 Hz, and the current intensity will be adjusted according to the participant's tolerance. Each session will last 30 minutes, administered twice weekly for 3 weeks (6 sessions in total).

OTHER

Sham Electroacupuncture (Control)

Participants in the control group will receive acupuncture at the same acupoints as the electroacupuncture groups using identical needling procedures to achieve the Deqi sensation. However, the needles will be connected to a specially designed sham electroacupuncture device that appears identical to the active SDZ-V electroacupuncture device but does not deliver electrical stimulation. Each treatment session will last 30 minutes and will be administered twice weekly for 3 weeks (6 sessions in total).

Sponsors & Collaborators

• The Third Affiliated hospital of Zhejiang Chinese Medical University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-03-01

Primary Completion

2027-09-30

Completion

2027-12-31

Countries

• China

Study Locations