Comparing manual and electroacupuncture for functional constipation
Response Characteristics of the Dose-Effect Relationship in Acupuncture Treatment for Functional Constipation: A Randomized Controlled Study
This trial will try manual acupuncture and electroacupuncture to see which produces more complete spontaneous bowel movements in adults with functional constipation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Tongji Hospital Academic / other |
| Locations | 2 sites (Wuhan, Hubei and 1 other locations) |
| Trial ID | NCT07506122 on ClinicalTrials.gov |
What this trial studies
This single-center, randomized, parallel-group trial will enroll 72 adults with functional constipation and randomize them 1:1 to manual acupuncture or electroacupuncture. Both groups receive 30-minute sessions at bilateral ST25 and ST37 three times per week for 12 weeks, while the electroacupuncture group receives additional continuous electrical stimulation (10 Hz, 0.5–4 mA). The primary outcome is the responder rate at week 12, defined as the percentage achieving ≥3 complete spontaneous bowel movements per week. Secondary outcomes include changes in gut microbiota, brain functional connectivity measured by multimodal MRI and fNIRS, and patient-reported symptom scales.
Who should consider this trial
Good fit: Adults aged 18–75 who meet Rome IV criteria for functional constipation with ≤2 CSBMs per week during a 14-day baseline, have had symptoms ≥6 months, and can attend thrice-weekly sessions and provide informed consent.
Not a fit: Patients whose constipation is secondary to other medical causes (such as IBS, neurological or endocrine disorders), those with pelvic floor dysfunction, recent unwashed use of laxatives/probiotics, or those unable to attend frequent in-person sessions are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the results could identify which acupuncture modality increases bowel frequency and help clinicians personalize treatment for functional constipation.
How similar studies have performed: Previous acupuncture trials for chronic constipation have reported modest benefits, but direct dose-response comparisons between manual and electroacupuncture are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Wuhan, Hubei and 1 other locations
- Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (Not_yet_recruiting)
- Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (Recruiting)
Study contacts
- Principal investigator: Shabei Xu — Tongji Hospital
- Study coordinator: Wensheng Qu
- Email: Qws0309@163.com
- Phone: +86-18971622660
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.