Health TrialsbyHealthPanel

Dose-Effect Response in Acupuncture for Functional Constipation

ConditionFunctional Constipation (FC)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorTongji Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Manual Acupuncture

    Other intervention

    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.

  • 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.

Treatment groups

72 Participants
are divided into 2 treatment groups
Group A: Manual Acupuncture GroupExperimental treatment 1 intervention
Group B: Electroacupuncture GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Responder Rate at Week 12

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

Time frame
Week 12

Secondary outcomes

1

Responder Rate at Week 16

Percentage of participants with ≥3 complete spontaneous bowel movements (CSBMs) per week at week 16

Time frame
Week 16
2

Changes in Blood Flow Measured by DCS

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

Time frame
Baseline, after deqi, weeks 2, 4, 6, 8, 10, 12, 16
3

Changes in Gut Microbiota

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

Time frame
Baseline, week 12, week 16, and at the time when CSBMs ≥3 per week is achieved
4

Changes in Brain Function

Changes in central neural network connectivity, functional activity of core brain regions, and brain glymphatic system function assessed by multimodal MRI

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tongji Hospital

Lead sponsor

Source ClinicalTrials.gov
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