Baliao Acupoint Stimulation toTreat Functional Constipation

NCT ID: NCT07010367

Last Updated: 2025-06-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-20
• Study Completion Date: 2026-07-30

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.

Conditions

Functional Constipation (FC)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

acupuncture group

Patients will receive acupuncture at Baliao acupuncts.

Group Type: EXPERIMENTAL

Acupuncture

Intervention Type: PROCEDURE

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 group

Patients will receive sham acupuncture treatment.

Group Type: SHAM_COMPARATOR

Sham acupuncture

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

OTHER

Sponsor Role: collaborator

Affiliated Hospital of Nanjing University of Chinese Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Chen Wei

Role: CONTACT

wisteria998@163.com

+86 15951953206

Other Identifiers

2024-056-SO

Identifier Type: -

Identifier Source: org_study_id