Evaluation of the Efficacy of Electroacupuncture in the Treatment of Functional Dyspepsia

NCT06618911 | Recruiting DMC

• 1 other identifier: 20240903074110247
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 4

Brief Summary

Brief Summary Template for the Study: The goal of this clinical trial is to evaluate whether electroacupuncture can treat functional dyspepsia (FD) in adult participants aged 18 to 65 years, including both males and females, who have been diagnosed with functional dyspepsia based on the Rome IV criteria. The main questions it aims to answer are:

• Does 5 Hz electroacupuncture improve symptoms in functional dyspepsia patients?
• Does 100 Hz electroacupuncture improve symptoms in functional dyspepsia patients?
• Are there differences in the efficacy between 5 Hz and 100 Hz electroacupuncture in treating functional dyspepsia and its subtypes (PDS and EPS)? Researchers will compare the effects of 5 Hz electroacupuncture, 100 Hz electroacupuncture, and sham electroacupuncture to determine which approach provides more significant symptom relief and whether different frequencies have varying impacts on FD subtypes. Participants will:
• Receive electroacupuncture treatment at specific acupoints (such as Liangmen, Tianshu, Zusanli, and Xiajuxu) for 30-minute sessions, 3 times a week for 4 weeks.
• Be randomly assigned to one of the following groups: 5 Hz electroacupuncture, 100 Hz electroacupuncture, or sham electroacupuncture (control).
• Have their functional dyspepsia symptoms, quality of life, and any adverse effects monitored and evaluated throughout the study.

Conditions

Functional Dyspepsia

Keywords

electroacupuncture; functional dyspepsia

Outcome Measures

Primary Outcomes (2)

• Symptom Improvement Rate at Week 4

  The primary outcome is the percentage of participants experiencing symptom improvement using the 7-point Likert scale for Overall Treatment Effect (OTE). The Overall Treatment Effect (OTE) questionnaire was categorized as "extremely worse than baseline," "worse than baseline," "slightly worse than baseline," "no change," "slightly improved than baseline," "improved than baseline," or "much improved than baseline." Participants will rate their symptom severity compared to baseline, and those reporting "improved than baseline" or "much improved than baseline"will be considered responders. The primary outcome will assess the efficacy of 5 Hz and 100 Hz electroacupuncture compared to sham treatment.

  4 weeks after the start of treatment.

• Main Symptom Resolution Rate at Week 4

  The second primary outcome is the rate of complete resolution of the main symptoms of functional dyspepsia at week 4. For Postprandial Distress Syndrome (PDS), the primary symptoms are postprandial fullness and early satiety; for Epigastric Pain Syndrome (EPS), the main symptoms are epigastric pain and burning. Complete resolution is defined as a score of 0 for the respective main symptoms on a validated symptom severity scale. The severity of each symptom is divided into: no symptoms (0 points), mild (1 point), moderate (2 points), and severe (3 points). The outcome will compare the resolution rates between the 5 Hz, 100 Hz, and sham electroacupuncture groups.

  4 weeks after the start of treatment.

Secondary Outcomes (5)

• Global Overall Symptom (GOS) Score Change

  Baseline to Week 4

• Nepean Dyspepsia Index (NDI) Score Change

  Baseline to Week 4

• Hospital Anxiety and Depression Scale (HADS) Score Change

  Baseline to Week 4

• Treatment Expectation Score

  Prior to the first treatment (Baseline)

• Blind evaluation

  immediately after 1st and 6th treatment sessions

Other Outcomes (1)

• Subgroup Analysis of Symptom Improvement by FD Subtypes (PDS vs. EPS)

  At Week 4

Study Arms (3)

5 Hz Electroacupuncture Group

EXPERIMENTAL

Participants will receive electroacupuncture at a frequency of 5 Hz at four acupoints: Liangmen (ST21) and Tianshu (ST25) (local acupoints), and Zusanli (ST36) and Xiajuxu (ST39) (distal acupoints). Disposable needles will be inserted until the "deqi" sensation is achieved. The needles will be connected to an SDZ-IIB electroacupuncture device set at 5 Hz, with stimulation lasting 30 minutes per session. Participants will receive 3 sessions per week for 4 weeks (total: 12 sessions). This group aims to evaluate the efficacy of low-frequency electroacupuncture for treating functional dyspepsia.

Other: 5 Hz electroacupuncture

100 Hz Electroacupuncture Group

EXPERIMENTAL

Participants will receive electroacupuncture at a frequency of 100 Hz at the same four acupoints: Liangmen (ST21), Tianshu (ST25), Zusanli (ST36), and Xiajuxu (ST39). Needles will be inserted to induce the "deqi" sensation and connected to an SDZ-IIB device set at 100 Hz, with stimulation lasting 30 minutes per session. Participants will receive 3 sessions per week for 4 weeks (total: 12 sessions). This group assesses the efficacy of high-frequency electroacupuncture for functional dyspepsia.

Other: 100 Hz electroacupuncture

Sham Electroacupuncture (Control) Group

SHAM COMPARATOR

Participants will receive sham electroacupuncture at the same acupoints: Liangmen (ST21), Tianshu (ST25), Zusanli (ST36), and Xiajuxu (ST39). Non-penetrating needles will touch the skin but will not induce "deqi." A sham electroacupuncture device (no actual current) will be used, and treatment will last 30 minutes per session. Participants will receive 3 sessions per week for 4 weeks (total: 12 sessions). This arm serves as a placebo control to evaluate the true effect of electroacupuncture.

Other: Sham electroacupuncture

Interventions

5 Hz electroacupuncture OTHER

Intervention Description: The intervention in this study involves the use of electroacupuncture (EA), a combination of traditional acupuncture and electrical stimulation. Acupoints Selection: Electroacupuncture will be performed at specific acupoints associated with the stomach and digestive system. The local acupoints chosen are Liangmen (ST21) and Tianshu (ST25), while the distal acupoints are Zusanli (ST36) and Xiajuxu (ST39). This selection is based on Traditional Chinese Medicine (TCM) principles for treating functional dyspepsia. Frequency: 5 Hz

5 Hz Electroacupuncture Group

Sham electroacupuncture OTHER

Participants will receive sham electroacupuncture at the same acupoints: Liangmen (ST21), Tianshu (ST25), Zusanli (ST36), and Xiajuxu (ST39). Non-penetrating needles will touch the skin but will not induce \"deqi.\" A sham electroacupuncture device (no actual current) will be used, and treatment will last 30 minutes per session. Participants will receive 3 sessions per week for 4 weeks (total: 12 sessions). This arm serves as a placebo control to evaluate the true effect of electroacupuncture.

Sham Electroacupuncture (Control) Group

100 Hz electroacupuncture OTHER

Intervention Description: The intervention in this study involves the use of electroacupuncture (EA), a combination of traditional acupuncture and electrical stimulation. Acupoints Selection: Electroacupuncture will be performed at specific acupoints associated with the stomach and digestive system. The local acupoints chosen are Liangmen (ST21) and Tianshu (ST25), while the distal acupoints are Zusanli (ST36) and Xiajuxu (ST39). This selection is based on Traditional Chinese Medicine (TCM) principles for treating functional dyspepsia. Frequency: 100 Hz

100 Hz Electroacupuncture 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:

• Diagnosed with functional dyspepsia based on Rome IV diagnostic criteria.
• Aged 18 to 80 years, inclusive, with no gender restrictions.
• Normal endoscopy results within the past year, showing no structural explanation for symptoms.
• No acupuncture treatment in the last month.
• Not participating in any other clinical trials in the past 2 months.
• Able to understand and provide informed consent.

You may not qualify if:

• Presence of serious or malignant diseases (e.g., cirrhosis, heart failure, gastrointestinal tumors) that could explain dyspepsia symptoms.
• Positive for Helicobacter pylori infection based on C-13 urea breath test or gastric biopsy.
• History of gastrointestinal surgery (excluding laparoscopic and other minimally invasive surgeries).
• Recent use (within 2 weeks) of medications affecting dyspepsia, including prokinetics, proton pump inhibitors, antacids, or antidepressants.
• Presence of severe mental or physical conditions, such as dementia or illiteracy, that could interfere with study participation.
• Severe coagulation disorders.
• Substance abuse or alcohol dependence.
• Pregnant or breastfeeding women.

Sponsors & Collaborators

• Yi Liang: lead
• Zhejiang Provincial Department of Science and Technology: collaborator

Study Sites (4)

The Third Affiliated Hospital of Zhejiang Chinese Medicinal University

Hangzhou, None Selected, 310053, China

RECRUITING

Hangzhou First People's Hospital

Hangzhou, Zhejiang, 310053, China

RECRUITING

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

Hangzhou, Zhejiang, 310053, China

RECRUITING

The First Affiliated Hospital of Zhejiang Chinese Medical University

Hangzhou, Zhejiang, 310053, China

RECRUITING

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: SPONSOR INVESTIGATOR
• PI Title: Research Fellow

Study Record Dates

• First Submitted: September 24, 2024
• First Posted: October 1, 2024
• Study Start: April 13, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: August 29, 2025

Record last verified: 2025-08

Data Sharing

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

Locations

CN (4)