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Not yet recruiting NCT07010367

Baliao Acupoint Stimulation toTreat Functional Constipation

No phase Interventional Functional Constipation (FC)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Acupuncture, Sham acupuncture.
Who it may be relevant to
Registry conditions: Functional Constipation (FC). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Effects and Mechanism of Baliao Acupoint Stimulation (BL31~BL34) for Functional Constipation

Overview

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.

Interventions

  • Procedure 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.
  • Procedure 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

  • Spontaneous bowel movements [Time frame: SBMs will be recorded 1 week before treatment and at 2, 4, 6, and 8 weeks after treatment.]
Secondary outcome measures (2)
  • PAC-SYM [Time frame: PAC-SYM will be assessed at 1 week before treatment and at 2, 4, 6, and 8 weeks after treatment]
  • PAC-QOL [Time frame: PAC-QOL will be accessed 1 week before treatment and at 2, 4, 6, and 8 weeks after treatment.]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07010367 · 2024-056-SO

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗