Efficacy Evaluation of Electroacupuncture in the Treatment of Functional Dyspepsia

NCT07496580 | Not Yet Recruiting

• 1 other identifier: 20260305031650208
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 4

Brief 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

Keywords

functional dyspepsia; electroacupuncture; Local Acupoints; Distal Acupoints

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Global Overall Symptom (GOS) Score

  Baseline (Week 0), Week 3, Week 7, Week 11, and Week 15

• Nepean Dyspepsia Index (NDI) Score

  Baseline (Week 0), Week 3, Week 7, Week 11, and Week 15

• Hospital Anxiety and Depression Scale (HADS) Score

  Baseline (Week 0), Week 3, Week 7, Week 11, and Week 15

• Expectation of Electroacupuncture Treatment

  Baseline (Week 0)

• Blinding Assessment

  Baseline (after Session 1) and Week 3 (after Session 6)

Study Arms (3)

local electroacupuncture group

EXPERIMENTAL

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)

distal electroacupuncture group

EXPERIMENTAL

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)

Acupuncture with Sham Electroacupuncture Group (Control Group)

SHAM COMPARATOR

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)

Interventions

Electroacupuncture (Local Acupoints) OTHER

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).

local electroacupuncture group

Electroacupuncture (Distal Acupoints) OTHER

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).

distal electroacupuncture group

Sham Electroacupuncture (Control) OTHER

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).

Acupuncture with Sham Electroacupuncture Group (Control Group)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (4)

Hangzhou First People's Hospital

Hangzhou, Zhejiang, 310053, China

Location

Sir Run Run Shaw Hospital, affiliated with the Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310053, China

Location

The First Affiliated Hospital of Zhejiang Chinese Medical University

Hangzhou, Zhejiang, 310053, China

Location

The Third Affiliated Hospital of Zhejiang Chinese Medicinal University

Hangzhou, Zhejiang, 310053, China

Location

MeSH Terms

Interventions

Electroacupuncture

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Acupuncture Therapy; Complementary Therapies; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia

Central Study Contacts

YI Liang, Doctor

CONTACT

+86 571 86633328; liangyiwww@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief TCM Physician

Study Record Dates

• First Submitted: March 16, 2026
• First Posted: March 27, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

CN (4)