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Идёт набор NCT07741227

Electroacupuncture on Neck Muscle Stiffness in Chronic Neck Pain

Без фазы С лечением Chronic Neck Pain

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: Electroacupuncture, Sham Electroacupuncture.
Кому может быть актуально
Состояния в реестре: Chronic Neck Pain. 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
Гонконг
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

The Immediate Effect of Electroacupuncture on Neck Muscle Stiffness in Individuals With Chronic Neck Pain

Обзор

This randomized, single-blind, placebo-controlled clinical trial aims to investigate the immediate physiological effects of a single session of electroacupuncture (EA) on neck muscle stiffness in individuals with chronic neck pain. While acupuncture is a widely used complementary therapy for musculoskeletal pain, high-quality, objective evidence demonstrating its immediate effects on muscle biomechanics remains limited. This study will utilize Shear Wave Elastography (SWE)-a non-invasive, objective ultrasound-based technology-to measure these changes. Adult participants aged 18 to 65 with non-specific chronic neck pain (lasting ≥ 3 months) will be randomly allocated into one of two groups: 1. True Electroacupuncture (EA) Group: Participants will receive a 20-minute session of active electroacupuncture with comfortable electrical stimulation at specific neck and tender points. 2. Sham Acupuncture (Placebo) Group: Participants will receive a 20-minute session of non-penetrating sham acupuncture with a deactivated electroacupuncture device to ensure participant blinding. The primary objective is to evaluate immediate changes in the stiffness of the upper trapezius muscle, measured objectively via SWE (as Young's Modulus in kPa) before and immediately after the intervention. Secondary objectives include assessing immediate post-treatment changes in subjective pain and stiffness (Visual Analogue Scale), Pressure Pain Threshold (PPT), and active Cervical Range of Motion (CROM), alongside a 7-day post-intervention follow-up questionnaire on neck function.

Вмешательства

  • Процедура Electroacupuncture
    A single 20-minute session of electroacupuncture administered by a registered Chinese Medicine Practitioner (\>10 years experience). Sterile single-use needles (0.25 mm × 25 mm or 0.30 mm × 40 mm) inserted at GB21, GB20, BL10, and local Ashi points on the affected upper trapezius to elicit de-qi. Needle pairs connected to a HANS-200A pulse generator delivering continuous asymmetric biphasic square wave at 2 Hz, pulse duration 200 μs, intensity titrated to maximum comfortable tolerance (checked e
  • Процедура Sham Electroacupuncture
    A single 20-minute session using validated Streitberger non-penetrating placebo needles at the same acupoints (GB21, GB20, BL10, Ashi). The blunt-tip needle retracts into the handle upon skin contact without penetrating the skin, secured with adhesive rings. The same HANS-200A device is connected but set to a deactivated mode (blinking lights and sounds active, no electrical current delivered). The practitioner follows an identical protocol and communication script as the EA group, including adj

Первичные конечные точки

  • Upper trapezius shear modulus [Срок оценки: Baseline (pre-intervention) and immediately post-intervention (within 15 minutes after needle removal, following a 5-minute rest period)]
Вторичные конечные точки (6)
  • Pain intensity (VAS) [Срок оценки: Baseline and immediately post-intervention]
  • Pressure pain threshold - ipsilateral splenius capitis [Срок оценки: Baseline and immediately post-intervention]
  • Pressure pain threshold - contralateral upper trapezius [Срок оценки: Baseline and immediately post-intervention]
  • Pressure pain threshold - contralateral splenius capitis [Срок оценки: Baseline and immediately post-intervention]
  • Pressure pain threshold - bilateral tibialis anterior (remote) [Срок оценки: Baseline and immediately post-intervention]
  • Cervical range of motion [Срок оценки: Baseline and immediately post-intervention]

Критерии участия

Критерии включения

  • Aged 18-65 years
  • Chronic non-specific neck pain persisting for ≥3 months
  • Average pain intensity ≥3 on a 0-10 Numeric Rating Scale over the past week
  • Pain primarily located in the posterior cervical region, which may radiate to the upper trapezius muscles
  • Able to provide informed consent and sufficient language proficiency to complete questionnaires

Критерии исключения

  • Specific pathological causes for neck pain (cervical radiculopathy or myelopathy, fracture, infection, tumour, systemic rheumatic disease)
  • History of neck or shoulder surgery
  • Contraindications to acupuncture (severe needle phobia, bleeding disorders, pregnancy)
  • Received acupuncture or other physical therapy for neck pain within the past 6 months

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
Двойное слепое
Основная цель
Лечение

Центры проведения

Гонконг · 1 центр
  • The Hong Kong Polytechnic University — Гонконг

Идентификаторы

NCT: NCT07741227 · HSEARS20250926007

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗