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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
72
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.
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.
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
NOT_YET_RECRUITINGTongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
RECRUITINGResponder Rate at Week 12
Percentage of participants with ≥3 complete spontaneous bowel movements (CSBMs) per week at week 12
Time frame: Week 12
Responder Rate at Week 16
Percentage of participants with ≥3 complete spontaneous bowel movements (CSBMs) per week at week 16
Time frame: Week 16
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
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
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
Changes in Cortical Activity Measured by fNIRS
Changes in cortical activity assessed by functional near-infrared spectroscopy (fNIRS)
Time frame: Baseline, after deqi, weeks 2, 4, 6, 8, 10, 12, 16
Acupuncture Expectancy Scale
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.
Time frame: Baseline
Patient Assessment of Constipation Quality of Life
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.
Time frame: Baseline, weeks 2, 4, 6, 8, 10, 12, 16
Generalized Anxiety Disorder 7-item Scale
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.
Time frame: Baseline, weeks 2, 4, 6, 8, 10, 12, 16
Patient Health Questionnaire-9
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.
Time frame: Baseline, weeks 2, 4, 6, 8, 10, 12, 16
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