Baliao Acupoint Stimulation toTreat Functional Constipation

NCT07010367 | Not Yet Recruiting

• 1 other identifier: 2024-056-SO
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

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)

Keywords

functional constipation; fMRI

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (2)

• PAC-SYM

  PAC-SYM will be assessed at 1 week before treatment and at 2, 4, 6, and 8 weeks after treatment

• PAC-QOL

  PAC-QOL will be accessed 1 week before treatment and at 2, 4, 6, and 8 weeks after treatment.

Other Outcomes (3)

• SAS

  SAS will be accessed 1 week before treatment and at 2, 4, 6, and 8 weeks after treatment.

• SDS

  SDS will be accessed 1 week before treatment and at 2, 4, 6, and 8 weeks after treatment.

• Amplitude of Low-Frequency Fluctuations

  at 1 week before treatment and 4 weeks after treatment

Study Arms (2)

acupuncture group

EXPERIMENTAL

Patients will receive acupuncture at Baliao acupuncts.

Procedure: Acupuncture

sham group

SHAM COMPARATOR

Patients will receive sham acupuncture treatment.

Procedure: Sham acupuncture

Interventions

Acupuncture 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.

acupuncture group

Sham acupuncture 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.

sham group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Affiliated Hospital of Nanjing University of Chinese Medicine: lead
• Guang'anmen Hospital of China Academy of Chinese Medical Sciences: collaborator

MeSH Terms

Interventions

Acupuncture Therapy

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Central Study Contacts

Chen Wei

CONTACT

+86 15951953206; wisteria998@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2025
• First Posted: June 8, 2025
• Study Start: June 20, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: June 8, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share