Baliao Acupoint Stimulation toTreat Functional Constipation

Официальное название

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

Обзор

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.

Вмешательства

• Процедура 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.
• Процедура 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.

Первичные конечные точки

• Spontaneous bowel movements [Срок оценки: SBMs will be recorded 1 week before treatment and at 2, 4, 6, and 8 weeks after treatment.]

Вторичные конечные точки (2)

• PAC-SYM [Срок оценки: PAC-SYM will be assessed at 1 week before treatment and at 2, 4, 6, and 8 weeks after treatment]
• PAC-QOL [Срок оценки: PAC-QOL will be accessed 1 week before treatment and at 2, 4, 6, and 8 weeks after treatment.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07010367 · 2024-056-SO

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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