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Набор скоро начнётся NCT06847945

Observation on the Curative Effect of Acupuncture At Sensitized Points on Gallbladder Meridian in the Treatment of Neck Type Cervical Spondylopathy

Без фазы С лечением Cervical Spondylopathy

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Sham acupuncture, Acupuncture.
Кому может быть актуально
Состояния в реестре: Cervical Spondylopathy. Базовые параметры: 18 лет — 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
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Официальное название

Changes of Acupoint Sensitization Characteristics on Gallbladder Meridian and Acupuncture Intervention Effect in Patients with Cervical Spondylosis

Обзор

To investigate the changes of acupoint sensitization characteristics of patients with Neck Type Cervical Spondylopathy through Gallbladder meridian observe the curative effect of acupuncture intervention and optimize the clinical diagnosis and treatment plan of acupuncture treatment of Neck Type Cervical Spondylopathy

Вмешательства

  • Процедура Sham acupuncture
    Patients in the non-meridian and non-acupoint group received sham acupuncture treatment at the position 2cm apart from the sensitized acupoint, once every other day for 30min each time, a total of 3 times for 1 week.
  • Процедура Acupuncture
    Patients in acupoint sensitization group were treated with pseudoacupuncture at the sensitized points once every other day for 30min each time, a total of 3 times for 1 week.

Первичные конечные точки

  • Visual Analogue Scale [Срок оценки: Before the start of treatment, immediately after the end of the third treatment, and four weeks after follow-up]
Вторичные конечные точки (5)
  • musculoskeletal ultrasound detection of cervical [Срок оценки: Before the start of treatment, immediately after the end of the third treatment]
  • Pressure pain threshold [Срок оценки: Before the start of treatment, immediately after the end of the third treatment, and four weeks after follow-up]
  • The Neck Disability Index [Срок оценки: Before the start of treatment, immediately after the end of the third treatment, and four weeks after follow-up]
  • Cervical range of motion scale [Срок оценки: Before the start of treatment, immediately after the end of the third treatment, and four weeks after follow-up]
  • The 12 items Short Form Health Survey [Срок оценки: Before the start of treatment, immediately after the end of the third treatment, and four weeks after follow-up]

Критерии участия

Критерии включения

  • Meeting the diagnostic criteria of Neck Type Cervical Spondylopathy.
  • Age 18 to 65 years old gender is not limited.
  • Clear awareness good compliance willing to cooperate with the study and accept the experimental arrangement.
  • Physical examination may or may not be accompanied by positive signs of the musculoskeletal system (including limited motor function local tender points etc.).
  • The visual analogue Scale (VAS) score was more than 3 points and less than 7 points (ranging from 0 to 10 points).
  • Informed consent and sign informed consent.

Критерии исключения

  • It does not meet the diagnostic criteria and inclusion criteria of cervical spondylosis.
  • Under 18 years of age or over 65 years of age;
  • 2 weeks before the start of the experiment the relevant treatment of the disease or the use of relevant therapeutic drugs;
  • Patients with other types of cervical spondylosis (cervical radiculopathy vertebral artery type cervical spondylosis cervical myelopathy sympathetic cervical spondylosis) or with other serious organic diseases and patients with neck and shoulder pain caused by non-neck diseases;
  • Patients with cardiovascular and cerebrovascular liver kidney digestive system blood system and other serious life-threatening primary diseases or suffering from hemorrhagic diseases or skin diseases or pregnant or lactating women or have a history of cardiac pacemaker implantation;
  • Previous history of neck surgery or neck fracture;
  • Persons with confusion mental disorder or cognitive impairment;
  • The skin at the test site has scars redness swelling heat and pain that affect the test result.

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

Китай · 1 центр
  • The Third Affiliated Hospital of Zhejiang Chinese Medicine University — Ханчжоу

Публикации

  • Li C, Wang J, Shao X, Wu Y, Qu X, Cai J, He L, Yu L, Xu R, Xia Y, Wang R, Zhang L, Qiu Y. Acupuncture at Sensitized Acupoints versus Sham Acupuncture for Neck-Type Cervical Spondylosis: Study Protocol for a Randomized Controlled Trial. J Pain Res. 2025 Dec 23;18:6963-6976. doi: 10.2147/JPR.S548317. eCollection 2025. PMID 41458188

Идентификаторы

NCT: NCT06847945 · ZSLL-KY-2023-040-03

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗