Baliao Acupoint Stimulation toTreat Functional Constipation

N/ANot Yet RecruitingNCT07010367

Affiliated Hospital of Nanjing University of Chinese Medicine36 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Functional Constipation (FC)

Interventions

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 acupuncturePROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: SBMs will be recorded 1 week before treatment and at 2, 4, 6, and 8 weeks after treatment.

Secondary Outcomes

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.

Time frame: 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.

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