Functional Constipation (FC)
Conditions
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.
Interventions
OTHERManual 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.
DEVICEElectroacupuncture
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.
Sponsors
Tongji Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Responder Rate at Week 12 | Week 12 | Percentage of participants with ≥3 complete spontaneous bowel movements (CSBMs) per week at week 12 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Blood Flow Measured by DCS | 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 |
| Changes in Gut Microbiota | 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 |
| Changes in Brain Function | 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 |
| Responder Rate at Week 16 | Week 16 | Percentage of participants with ≥3 complete spontaneous bowel movements (CSBMs) per week at week 16 |
| Changes in Quality of Life and Mood | Baseline, weeks 2, 4, 6, 8, 10, 12, 16 | Changes in Patient Assessment of Constipation Quality of Life and Anxiety and Depression Scale scores |
| Acupuncture Expectancy Scale Score | Baseline | Acupuncture Expectancy Scale score assessed before treatment |
| Changes in Cortical Activity Measured by fNIRS | Baseline, after deqi, weeks 2, 4, 6, 8, 10, 12, 16 | Changes in cortical activity assessed by functional near-infrared spectroscopy (fNIRS) |
Countries
China
Contacts
CONTACTWensheng Qu
CONTACTShabei Xu
PRINCIPAL_INVESTIGATORShabei Xu
Tongji Hospital
Outcome results
None listed