Dose-Effect Response in Acupuncture for Functional Constipation

May 11, 2026 updated by: Xu Shabei, Tongji Hospital

Response Characteristics of the Dose-Effect Relationship in Acupuncture Treatment for Functional Constipation: A Randomized Controlled Study

This is a single-center, randomized, parallel-group trial evaluating the dose-response relationship of two experimental interventions: manual acupuncture and electroacupuncture for functional constipation.

A total of 72 participants with functional constipation (Rome IV criteria) will be randomly assigned in a 1:1 ratio to either the manual acupuncture group or the electroacupuncture group. Both groups receive acupuncture at bilateral Tianshu (ST25) and Shangjuxu (ST37) points, 30 minutes per session, three times per week for 12 weeks. The electroacupuncture group additionally receives electrical stimulation (continuous wave, 10 Hz, 0.5-4 mA).

The primary outcome is the responder rate at week 12, defined as the percentage of participants with ≥3 complete spontaneous bowel movements (CSBMs) per week. Secondary outcomes include changes in gut microbiota, brain functional connectivity measured by multimodal MRI and fNIRS, and scales.

The study aims to clarify the dose-response characteristics of different acupuncture modalities and their underlying biological mechanisms.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Recruiting
        • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • Contact:
      • Wuhan, Hubei, China, 430030
        • Not yet recruiting
        • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Meet Rome IV diagnostic criteria for functional constipation
  • Symptoms present for ≥6 months, meeting diagnostic criteria in the last 3 months
  • Mean weekly complete spontaneous bowel movements (CSBMs) ≤2 during 14-day baseline period
  • Age 18-75 years
  • No use of constipation medications for at least 2 weeks prior to treatment (except rescue medication)
  • No acupuncture treatment for constipation in the past 3 months
  • Not currently participating in another clinical trial
  • Willing and able to provide written informed consent

Exclusion Criteria:

  • Constipation secondary to other causes (IBS, organic diseases, medications, endocrine disorders, metabolic disorders, neurological disorders, or gastrointestinal surgery)
  • Loose or watery stools (Bristol type 6 or 7) >1 time during baseline without laxative use
  • History of pelvic floor dysfunction
  • Use of probiotics, fiber supplements, or laxatives within 2 weeks prior to treatment (2-week washout required)
  • Severe hemorrhoids or anal fissures
  • Severe or uncontrolled heart, liver, or kidney disease; abdominal aortic aneurysm; hepatosplenomegaly; cognitive impairment; or psychiatric disorders
  • Dependence on opioids or anticholinergic drugs
  • Red flags: unexplained weight loss >10% in 3 months, hematochezia or positive fecal occult blood, family history of colon cancer (first-degree relative diagnosed <50 years), anemia (Hb <110 g/L), or elevated inflammatory markers
  • Contraindications to acupuncture: coagulation disorders or use of anticoagulants
  • Pregnancy or breastfeeding
  • Unable to comply with follow-up or contraindications to MRI (e.g., cardiac pacemaker, non-titanium aneurysm clips, metallic implants, claustrophobia)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Manual Acupuncture Group
Other: Manual Acupuncture
Acupuncture at bilateral Tianshu (ST25) and Shangjuxu (ST37). Participant lies supine and rests for 5 minutes before treatment. After routine disinfection, the acupuncturist inserts needles vertically to a certain depth, followed by mild lifting, thrusting, and twisting for 10 seconds at each acupoint to induce deqi. Needles are retained for 30 minutes. After removal, needle holes are pressed to prevent bleeding. Treatment frequency: three sessions per week for 12 weeks.
Experimental: Electroacupuncture Group
Device: Electroacupuncture
Acupuncture at bilateral Tianshu (ST25) and Shangjuxu (ST37). Participant lies supine and rests for 5 minutes before treatment. After routine disinfection, the acupuncturist inserts needles vertically to a certain depth, followed by mild lifting, thrusting, and twisting for 10 seconds at each acupoint to induce deqi. Then needles are connected to an electroacupuncture device (Hwato SDZ-III, Suzhou Medical Products Factory, China). Two pairs of electrodes are attached: one pair to bilateral Tianshu (ST25), the other to bilateral Shangjuxu (ST37). Electrical stimulation: continuous wave, 10 Hz, current intensity 0.5-4 mA adjusted to patient tolerance. Electroacupuncture duration: 30 minutes. After needle removal, press to prevent bleeding. Treatment frequency: three sessions per week for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Responder Rate at Week 12
Time Frame: Week 12
Percentage of participants with ≥3 complete spontaneous bowel movements (CSBMs) per week at week 12
Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Responder Rate at Week 16
Time Frame: Week 16
Percentage of participants with ≥3 complete spontaneous bowel movements (CSBMs) per week at week 16
Week 16
Changes in Blood Flow Measured by DCS
Time Frame: Baseline, after deqi, weeks 2, 4, 6, 8, 10, 12, 16
Changes in blood flow at acupoints, intestinal body surface projection areas, and abdominal muscle tissue measured by diffuse correlation spectroscopy (DCS), with concurrent monitoring of local pressure and temperature
Baseline, after deqi, weeks 2, 4, 6, 8, 10, 12, 16
Changes in Gut Microbiota
Time Frame: Baseline, week 12, week 16, and at the time when CSBMs ≥3 per week is achieved
Changes in gut microbiota diversity and composition analyzed by 16S rRNA sequencing, and changes in gut metabolites (e.g., short-chain fatty acids) measured by targeted metabolomics
Baseline, week 12, week 16, and at the time when CSBMs ≥3 per week is achieved
Changes in Brain Function
Time Frame: Baseline, after deqi, week 12, week 16, and at the time when CSBMs ≥3 per week is achieved
Changes in central neural network connectivity, functional activity of core brain regions, and brain glymphatic system function assessed by multimodal MRI
Baseline, after deqi, week 12, week 16, and at the time when CSBMs ≥3 per week is achieved
Changes in Cortical Activity Measured by fNIRS
Time Frame: Baseline, after deqi, weeks 2, 4, 6, 8, 10, 12, 16
Changes in cortical activity assessed by functional near-infrared spectroscopy (fNIRS)
Baseline, after deqi, weeks 2, 4, 6, 8, 10, 12, 16
Acupuncture Expectancy Scale
Time Frame: Baseline
A 4-item patient-reported questionnaire assessing patients' expectancy of positive outcomes from acupuncture therapy, including improvement of illness, enhanced coping, increased vitality, and symptom alleviation. Each item is scored from 1 (not at all agree) to 5 (completely agree), with total scores ranging from 4 to 20. Higher scores indicate greater expectancy of benefit from acupuncture treatment.
Baseline
Patient Assessment of Constipation Quality of Life
Time Frame: Baseline, weeks 2, 4, 6, 8, 10, 12, 16
A 28-item patient-reported questionnaire assessing constipation-related quality of life, consisting of four domains: physical discomfort, psychosocial discomfort, worries and concerns, and satisfaction. Each item is scored from 0 to 4, with total scores ranging from 0 to 112. Higher scores indicate worse constipation-related quality of life.
Baseline, weeks 2, 4, 6, 8, 10, 12, 16
Generalized Anxiety Disorder 7-item Scale
Time Frame: Baseline, weeks 2, 4, 6, 8, 10, 12, 16
A 7-item patient-reported questionnaire assessing anxiety symptoms over the past two weeks. Each item is scored from 0 (not at all) to 3 (nearly every day), with total scores ranging from 0 to 21. Higher scores indicate more severe anxiety symptoms.
Baseline, weeks 2, 4, 6, 8, 10, 12, 16
Patient Health Questionnaire-9
Time Frame: Baseline, weeks 2, 4, 6, 8, 10, 12, 16
A 9-item patient-reported questionnaire assessing depressive symptoms over the past two weeks, based on the DSM-IV diagnostic criteria for depression. Each item is scored from 0 (not at all) to 3 (nearly every day), with total scores ranging from 0 to 27. Higher scores indicate more severe depressive symptoms.
Baseline, weeks 2, 4, 6, 8, 10, 12, 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tongji Hospital

Investigators

  • Principal Investigator: Shabei Xu, Tongji Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 11, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

March 26, 2026

First Submitted That Met QC Criteria

March 26, 2026

First Posted (Actual)

April 1, 2026

Study Record Updates

Last Update Posted (Actual)

May 14, 2026

Last Update Submitted That Met QC Criteria

May 11, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TJ-IRB202603096

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Functional Constipation (FC)

Clinical Trials on Manual Acupuncture

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Estonia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe