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Baliao Acupoint Stimulation toTreat Functional Constipation 36 Randomized
Clinical Trial NCT07010367 is an interventional study for Functional Constipation (FC) and is currently not yet recruiting. Enrollment is planned to begin on 20 June 2025 and continue until the study accrues 36 participants. Led by Affiliated Hospital of Nanjing University of Chinese Medicine, this study is expected to complete by 30 July 2026. The latest data from ClinicalTrials.gov was last updated on 8 June 2025.
Brief Summary
This study is a randomized controlled trial that explores how a specific acupuncture treatment might help people with functional constipation. The investigators are testing the idea that a treatment called "acupuncture at the Baliao acupoints" could work by changing the way certain parts of the brain connect and function. These brain changes might help improve gut function and relieve constipation symptoms.
The inve...
Show MoreOfficial Title
Effects and Mechanism of Baliao Acupoint Stimulation (BL31~BL34) for Functional Constipation
Conditions
Functional Constipation (FC)Other Study IDs
- 2024-056-SO
NCT ID Number
Start Date (Actual)
2025-06-20
Last Update Posted
2025-06-08
Completion Date (Estimated)
2026-07-30
Enrollment (Estimated)
36
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Keywords
functional constipation
fMRI
fMRI
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Triple
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
Experimentalacupuncture group Patients will receive acupuncture at Baliao acupuncts. | Acupuncture Patients will be instructed to lie in the supine position. After strict disinfection of the acupoints area, acupuncture needles will be inserted into the Baliao points (inserted at the surface projections of the first, second, and third pairs of sacral foramina, with a depth of 3-4 cm). The treatment will be administered five times per week, with each session lasting 30 minutes, for a total of two weeks. |
Sham Comparatorsham group Patients will receive sham acupuncture treatment. | Sham acupuncture Patients will be instructed to lie in the supine position. After strict disinfection of the sham acupoints area, acupuncture needles will be inserted lateral to the surface projections of the first, second, and third pairs of sacral foramina, with a depth of 1 cm.The treatment will be administered five times per week, with each session lasting 30 minutes, for a total of two weeks. |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Spontaneous bowel movements | Spontaneous bowel movements (SBMs) refers to the frequency of bowel movements that occur without the use of any medications or other aids within the past 24 hours. These data are collected from the constipation diaries filled out daily by patients with functional constipation (FC) to determine the weekly count of SBMs. The data collection time points include before treatment and at 2, 4, 6, and 8 weeks after treatment. | SBMs will be recorded 1 week before treatment and at 2, 4, 6, and 8 weeks after treatment. |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
PAC-SYM | Patient Assessment of Constipation symptom(PAC-SYM) is a tool used to evaluate the symptoms and severity of constipation in patients. The scale consists of three sections: stool symptoms, rectal symptoms, and abdominal symptoms, with a total of 12 items. The score ranges from 0 to 48, with higher scores indicating more severe constipation symptoms. | PAC-SYM will be assessed at 1 week before treatment and at 2, 4, 6, and 8 weeks after treatment |
PAC-QOL | Patient Assessment of Constipation quality of life is a tool used to assess the impact of constipation on patients' quality of life. The scale, known as PAC-QOL, consists of four dimensions: Physical Discomfort (4 items), Psychosocial Discomfort (8 items), Worries and Discomfort (11 items), and Treatment Satisfaction (5 items), with a total of 28 items. The score ranges from 0 to 112, with higher scores indicating a greater negative impact of constipation on quality of life. | PAC-QOL will be accessed 1 week before treatment and at 2, 4, 6, and 8 weeks after treatment. |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- Age:18 years or older.
- Diagnosed with functional constipation according to the Rome IV criteria.
- The participant has not received any treatment for functional constipation in the past two weeks (except for emergency interventions).
- Right-handed.
- Signed a written informed consent form to participate in this study.
- Presence of organic constipation, drug-induced constipation, or systemic constipation.
- Presence of metallic foreign bodies in the body, pacemakers, or other contraindications for MRI examination.
- Communication disorders or unwillingness to cooperate with treatment.
Affiliated Hospital of Nanjing University of Chinese MedicineGuang'anmen Hospital of China Academy of Chinese Medical SciencesStudy Central Contact
Contact: Chen Wei, +86 15951953206, [email protected]
No location data.