NCT07496580

Efficacy Evaluation of Electroacupuncture in the Treatment of Functional Dyspepsia

Efficacy Evaluation of Electroacupuncture in the Treatment of Functional Dyspepsia: A Multicenter Clinical Trial Study

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 105 (estimated)
• Sponsor: The Third Affiliated hospital of Zhejiang Chinese Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Functional dyspepsia (FD) significantly impairs patients' quality of life and is often accompanied by psychological distress. While traditional acupuncture is widely used in the treatment of FD, electroacupuncture has been suggested to enhance therapeutic effects by providing continuous, standardized electrical stimulation to specific acupoints. However, the comparative effectiveness of targeting local abdominal acupoints versus distal limb acupoints remains unclear. This multicenter randomized controlled trial is designed to investigate the physiological and clinical effects of electroacupuncture on FD. Following informed consent, participants are randomly assigned in a 1:1:1 ratio to one of three parallel arms: Local Electroacupuncture Group: Electrical stimulation applied to selected abdominal acupoints. Distal Electroacupuncture Group: Electrical stimulation applied to selected limb acupoints. Control Group: Acupuncture with a sham electroacupuncture device that delivers no electrical current. The intervention phase consists of treatments administered twice weekly for 3 weeks (totaling 6 sessions). All procedures are standardized and performed by licensed acupuncturists with a minimum of three years of clinical experience. Active groups utilize a standard electroacupuncture device to deliver the current, while the sham group is designed to maintain blinding without providing active electrical stimulation. Following the intervention phase, participants enter a 12-week follow-up period to assess the sustainability of the therapeutic effects. By comparing local and distal stimulation strategies, this research intends to elucidate the optimal clinical application of electroacupuncture and provide evidence-based guidance for the management of functional dyspepsia.

Conditions

• Functional Dyspepsia
• Electroacupuncture

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2026-03-01
• Primary completion: 2027-09-30
• Completion: 2027-12-31
• First posted: 2026-03-27
• Last updated: 2026-03-27

Locations

4 sites across 1 country: China