Dose-Effect Response in Acupuncture for Functional Constipation

NCT07506122 | Recruiting

• 1 other identifier: TJ-IRB202603096
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Functional Constipation (FC)

Outcome Measures

Primary Outcomes (1)

• Responder Rate at Week 12

  Percentage of participants with ≥3 complete spontaneous bowel movements (CSBMs) per week at week 12

  Week 12

Secondary Outcomes (9)

• Responder Rate at Week 16

  Week 16

• Changes in Blood Flow Measured by DCS

  Baseline, after deqi, weeks 2, 4, 6, 8, 10, 12, 16

• Changes in Gut Microbiota

  Baseline, week 12, week 16, and at the time when CSBMs ≥3 per week is achieved

• Changes in Brain Function

  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

  Baseline, after deqi, weeks 2, 4, 6, 8, 10, 12, 16

Study Arms (2)

Manual Acupuncture Group

EXPERIMENTAL

Other: Manual Acupuncture

Electroacupuncture Group

EXPERIMENTAL

Device: Electroacupuncture

Interventions

Electroacupuncture DEVICE

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.

Electroacupuncture Group

Manual Acupuncture OTHER

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.

Manual Acupuncture Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Tongji Hospital: lead

Study Sites (2)

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

NOT YET RECRUITING

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

RECRUITING

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

Study Officials

• Shabei Xu

  Tongji Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wensheng Qu

CONTACT

+86-18971622660; Qws0309@163.com

Shabei Xu

CONTACT

+86-13554178768; xushabei@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician；Associate Professor；Associate Director, Department of Neurology；Associate Director of Clinical Research Center

Study Record Dates

• First Submitted: March 26, 2026
• First Posted: April 1, 2026
• Study Start: May 11, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 14, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)