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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Functional Dyspepsia; Electroacupuncture
• Intervention / Treatment: Other: Electroacupuncture (Local Acupoints); Other: Electroacupuncture (Distal Acupoints); Other: Sham Electroacupuncture (Control)

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.

• Study Type: Interventional
• Enrollment (Estimated): 105
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: YI Liang, Doctor; Phone Number: +86 571 86633328; Email: liangyiwww@126.com

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310053
      • Hangzhou First People's Hospital
      • Contact: siyi zheng, Doctor; Email: zsy980714@gmail.com
    • Hangzhou, Zhejiang, China, 310053
      • The Third Affiliated Hospital of Zhejiang Chinese Medicinal University
      • Contact: Chenben Zhang; Phone Number: +86-18815051075; Email: 1262243501@qq.com
    • Hangzhou, Zhejiang, China, 310053
      • Sir Run Run Shaw Hospital, affiliated with the Zhejiang University School of Medicine
    • Hangzhou, Zhejiang, China, 310053
      • The First Affiliated Hospital of Zhejiang Chinese Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Participants who meet the Rome IV diagnostic criteria for functional dyspepsia (FD).
• Age 18 to 80 years, male or female.
• Chinese patients with a normal upper gastrointestinal endoscopy within the past 1 year, or judged by a gastroenterologist with more than 3 years of clinical experience to have no structural disease that explains the symptoms.
• Willing and able to provide written informed consent and comply with study procedures.

Exclusion Criteria:

• Functional dyspepsia symptoms caused by severe or malignant diseases (e.g., liver cirrhosis, heart failure, or gastrointestinal tumors).
• Helicobacter pylori infection, defined as a positive urea breath test or positive Hp test on endoscopy.
• History of gastrointestinal surgery (except minimally invasive procedures such as laparoscopy).
• Presence of a permanent or temporary cardiac pacemaker or use of external/temporary pacing support.
• Use of medications that may affect dyspepsia symptoms within 2 weeks prior to enrollment, including antisecretory drugs, antacids, prokinetic agents, digestive enzymes, nonsteroidal anti-inflammatory drugs, antidepressants, or traditional Chinese medicine for FD.
• Conditions that may make participation difficult, such as severe mental or physical illness, dementia, or illiteracy.
• Severe coagulation disorders.
• Acupuncture treatment for gastrointestinal diseases within the past 1 month.
• Participation in another clinical trial within the past 2 months.
• Drug abuse or alcohol abuse.
• Pregnant or breastfeeding women.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: local electroacupuncture group; Participants in this group 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 to achieve the sensation of Deqi. Two pairs of acupoints (Shangwan-Zhongwan and left Liangmen-right Liangmen) will be connected to an electroacupuncture device delivering electrical stimulation at a frequency of 5 Hz for 30 minutes. Treatments will be administered twice per week for 3 weeks, totaling 6 sessions.	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).
Experimental: distal electroacupuncture group; 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 to elicit the Deqi sensation. Electroacupuncture will be applied by connecting bilateral Zusanli and Xiajuxu to an electroacupuncture device with a frequency of 5 Hz for 30 minutes. Treatments will be performed twice weekly for 3 weeks, totaling 6 sessions.	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).
Sham Comparator: Acupuncture with Sham Electroacupuncture Group (Control Group); Participants in the control group will receive acupuncture at the same acupoints as the electroacupuncture groups. Needles will be inserted using the same technique to elicit Deqi. However, the needles will be connected to a specially designed sham electroacupuncture device that looks identical to the real device but does not deliver electrical stimulation. Each treatment session will last 30 minutes, administered twice per week for 3 weeks, for a total of 6 sessions.	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Treatment Effect (OTE) Response Rate at Week 3	The overall treatment effect will be assessed using a 7-point Likert scale evaluating the change in gastrointestinal symptoms compared with baseline. Participants who report "improved" or "extremely improved" will be considered responders. The response rate will be calculated as the proportion of participants achieving improvement at the end of the 3-week treatment period.	Week 3
Main Symptom Elimination Rate at Week 3	The elimination rate of the main symptoms will be defined as the proportion of participants whose primary symptoms score is 0 (no symptoms) at week 3. In the postprandial distress syndrome (PDS) subtype, the main symptoms include postprandial fullness and/or early satiety. In the epigastric pain syndrome (EPS) subtype, the main symptoms include epigastric pain and/or burning. For participants with combined PDS and EPS, the main symptoms include both symptom categories.	Week 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Global Overall Symptom (GOS) Score	The Global Overall Symptom (GOS) scale will be used to assess the severity of eight dyspeptic symptoms, including epigastric pain, epigastric burning, regurgitation, postprandial fullness, nausea/vomiting, belching, early satiety, and heartburn. Each symptom is rated on a 7-point Likert scale ranging from 1 (no problem) to 7 (very severe problem). Changes in GOS scores will be evaluated over time to assess symptom improvement.	Baseline (Week 0), Week 3, Week 7, Week 11, and Week 15
Nepean Dyspepsia Index (NDI) Score	Health-related quality of life in patients with functional dyspepsia will be evaluated using the Nepean Dyspepsia Index (NDI). The NDI quality-of-life total score ranges from a minimum of 0 to a maximum of 100, where higher scores indicate a better health-related quality of life (less impairment from dyspepsia). The scale measures the impact of dyspepsia on multiple aspects of daily life, including tension, interference with daily activities, eating/drinking, knowledge/control, and work/study. Changes in NDI scores will be assessed during treatment and follow-up.	Baseline (Week 0), Week 3, Week 7, Week 11, and Week 15
Hospital Anxiety and Depression Scale (HADS) Score	The Hospital Anxiety and Depression Scale (HADS) will be used to assess levels of anxiety and depression in participants. The HADS consists of two subscales: Anxiety (HADS-A) and Depression (HADS-D). Each subscale score ranges from a minimum of 0 to a maximum of 21. If combined into a total score, the minimum is 0 and the maximum is 42. For both the subscales and the total score, higher scores indicate higher levels of anxiety and depression (a worse outcome). Changes in HADS scores will be evaluated to explore the psychological effects of the intervention.	Baseline (Week 0), Week 3, Week 7, Week 11, and Week 15
Expectation of Electroacupuncture Treatment	Before treatment, participants will be asked to evaluate their expectations regarding the effectiveness of electroacupuncture using a 5-point scale (strongly agree, agree, neutral, disagree, strongly disagree) in response to the statement that electroacupuncture will significantly improve their symptoms.	Baseline (Week 0)
Blinding Assessment	Participants will be asked to guess whether they received electroacupuncture or sham electroacupuncture after the first treatment session and after the sixth treatment session in order to assess the effectiveness of blinding.	Baseline (after Session 1) and Week 3 (after Session 6)
Treatment Adherence	Treatment adherence will be evaluated by recording whether participants complete the scheduled treatment sessions and outcome assessments. Reasons for withdrawal, exclusion, or loss to follow-up will also be documented.	Week 0, Week 3, and Week 15
Safety Outcomes (Adverse Events)	All adverse events occurring during the study period will be recorded and evaluated to assess the safety of electroacupuncture treatment.	From baseline to Week 15

Collaborators and Investigators

• Sponsor: The Third Affiliated hospital of Zhejiang Chinese Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: March 16, 2026
• First Submitted That Met QC Criteria: March 22, 2026
• First Posted (Actual): March 27, 2026

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 22, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: electroacupuncture; functional dyspepsia; Local Acupoints; Distal Acupoints
• Additional Relevant MeSH Terms: Therapeutics; Complementary Therapies; Physical Therapy Modalities; Rehabilitation; Anesthesia and Analgesia; Electric Stimulation Therapy; Combined Modality Therapy; Anesthesia; Analgesia; Acupuncture Therapy; Transcutaneous Electric Nerve Stimulation; Electroacupuncture
• Other Study ID Numbers: 20260305031650208

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No