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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Manual Acupuncture Group | Experimental |
| |
| Electroacupuncture Group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Responder Rate at Week 12 | Percentage of participants with ≥3 complete spontaneous bowel movements (CSBMs) per week at week 12 | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Responder Rate at Week 16 | Percentage of participants with ≥3 complete spontaneous bowel movements (CSBMs) per week at week 16 | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wensheng Qu | Contact | +86-18971622660 | Qws0309@163.com | |
| Shabei Xu | Contact | +86-13554178768 | xushabei@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Shabei Xu | Tongji Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology | Not yet recruiting | Wuhan | Hubei | 430030 | China |
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| ID | Term |
|---|---|
| D015671 | Electroacupuncture |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D015670 | Acupuncture Therapy |
| D000529 | Complementary Therapies |
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| 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. |
|
| 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 | 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 | 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) | 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. | 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. | 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. | 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. | Baseline, weeks 2, 4, 6, 8, 10, 12, 16 |
| Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology | Recruiting | Wuhan | Hubei | 430030 | China |
|
| D004599 |
| Electric Stimulation Therapy |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
| D004561 | Transcutaneous Electric Nerve Stimulation |
| D000698 | Analgesia |
| D000760 | Anesthesia and Analgesia |
| D000758 | Anesthesia |