Clinical trial NCT07010367: Baliao Acupoint Stimulation toTreat Functional Constipation
Official title: Effects and Mechanism of Baliao Acupoint Stimulation (BL31~BL34) for Functional Constipation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Functional Constipation (FC)
Keywords: functional constipation
fMRI
Lead sponsor: Affiliated Hospital of Nanjing University of Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
First posted: 2025-06-08
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 investigators will work with people who have functional constipation. Some participants will receive the real Baliao acupoint thread embedding, while others will get a sham acupuncture as a comparison. Using special brain imaging techniques, the investigators will look at how the brain's connections and structures change. The investigators will also track how often participants have bowel movements, the consistency of their stools, and their overall symptoms and quality of life. By comparing these results, the investigators hope to understand how the Baliao acupoint treatment works and why it might be effective for constipation.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Spontaneous bowel movements
timeFrame: SBMs will be recorded 1 week before treatment and at 2, 4, 6, and 8 weeks after treatment.
Secondary outcomes:
measure: PAC-SYM
timeFrame: PAC-SYM will be assessed at 1 week before treatment and at 2, 4, 6, and 8 weeks after treatment
measure: PAC-QOL
timeFrame: PAC-QOL will be accessed 1 week before treatment and at 2, 4, 6, and 8 weeks after treatment.
Other outcomes:
measure: SAS
timeFrame: SAS will be accessed 1 week before treatment and at 2, 4, 6, and 8 weeks after treatment.
measure: SDS
timeFrame: SDS will be accessed 1 week before treatment and at 2, 4, 6, and 8 weeks after treatment.
measure: Amplitude of Low-Frequency Fluctuations
timeFrame: at 1 week before treatment and 4 weeks after treatment
Locations:
Study officials:
References: