The Immediate Effect of Electroacupuncture on Neck Muscle Stiffness in Individuals With Chronic Neck Pain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Upper trapezius shear modulus
研究概览
简要总结
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:
- True Electroacupuncture (EA) Group: Participants will receive a 20-minute session of active electroacupuncture with comfortable electrical stimulation at specific neck and tender points.
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Upper trapezius shear modulus
时间窗: Baseline (pre-intervention) and immediately post-intervention (within 15 minutes after needle removal, following a 5-minute rest period)
Shear modulus (kPa) of the upper trapezius muscle measured by shear-wave elastography (SWE) at the midpoint between C7 spinous process and acromion on the treated side. Mean of 3 consecutive measurements. Young's modulus values divided by 3 to obtain shear modulus.
次要结局
- Pain intensity (VAS)(Baseline and immediately post-intervention)
- Pressure pain threshold - ipsilateral splenius capitis(Baseline and immediately post-intervention)
- Pressure pain threshold - contralateral upper trapezius(Baseline and immediately post-intervention)
- Pressure pain threshold - contralateral splenius capitis(Baseline and immediately post-intervention)
- Pressure pain threshold - bilateral tibialis anterior (remote)(Baseline and immediately post-intervention)
- Cervical range of motion(Baseline and immediately post-intervention)