A Comparative Study on the Effect of Vagus Nerve Stimulation and Ischemic Compression on Trapezius Trigger Points
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Pain Intensity (VAS)(Visual Analog Scale )
研究概览
简要总结
This randomized controlled trial aimed to evaluate the efficacy of non-invasive vagus nerve stimulation (nVNS) compared to ischemic compression (trigger point massage) and exercise in treating trigger points in the upper trapezius muscle. Ninety participants aged 18-55 with at least two trigger points were randomly assigned to three groups: nVNS, ischemic compression, or exercise (control). Interventions were administered over 10 sessions (3 times per week). Outcomes included pain intensity (Visual Analog Scale, VAS), trigger point number, pain pressure threshold (algometer), neck function (Copenhagen Neck Functional Disability Scale, KBFÖS), well-being (WHO-5 Well-Being Index), and functional mobility. The nVNS group demonstrated statistically significant improvements in all outcomes compared to the other groups (p < 0.05).
详细描述
Myofascial pain syndrome (MPS) is characterized by trigger points-hyperirritable spots in skeletal muscle associated with pain, stiffness, and reduced function. The upper trapezius muscle is a common site for trigger points, contributing to neck pain and disability. Traditional treatments include ischemic compression and exercise, but non-invasive vagus nerve stimulation (nVNS) has emerged as a promising modality due to its ability to modulate pain pathways and autonomic function.
This study investigated whether nVNS is more effective than ischemic compression or exercise in reducing pain and improving function in patients with trapezius trigger points. Participants were randomized into three groups (n=30 each)
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
- Single (Outcomes Assessor)
盲法说明
This study employs single blinding, where the outcomes assessors are masked to the participants' group assignments. Participants are randomized into one of three groups (non-invasive vagus nerve stimulation, ischemic compression, or exercise), and the interventions are administered by unblinded study personnel. To minimize bias, assessors responsible for measuring outcomes, including pain intensity (Visual Analog Scale), number of trigger points, pain pressure threshold (algometer), neck function (Copenhagen Neck Functional Disability Scale), well-being (WHO-5 Well-Being Index), and functional mobility, are unaware of the intervention each participant receives. Participants and intervention providers are not blinded due to the nature of the interventions.
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-55 years.
- •Presence of at least two trigger points (active or latent) in the upper trapezius muscle, confirmed by palpation.
- •Ability to provide informed consent.
排除标准
- •History of cervical spine surgery or trauma.
- •Neurological disorders (e.g., epilepsy, stroke).
- •Pregnancy or breastfeeding.
- •Use of pacemakers or other implanted electrical devices.
- •Active infection or skin lesions at the stimulation site.
- •Recent use of botulinum toxin or other trigger point injections.
研究组 & 干预措施
Arm 2: Ischemic Compression
Participants receive manual trigger point massage (ischemic compression) applied to trapezius trigger points for 30-90 seconds per point, 3 times per week for 10 sessions.
干预措施: Ischemic Compression (Procedure)
Arm 1: Vagus Nerve Stimulation (nVNS)
Participants receive non-invasive auricular vagus nerve stimulation bilaterally to the concha and tragus using a TENS-based device (10 Hz, 300 µs, 20 minutes per session) for 10 sessions over 4 weeks, with intensity adjusted to patient comfort.
干预措施: Vagus Nerve Stimulation (nVNS) (Device)
Exercise (Control)
Participants perform a standardized exercise program including isometric neck exercises, upper trapezius stretching, and chin tuck exercises, conducted 3 times per week for 10 sessions.
干预措施: Exercise (Control) (Behavioral)
结局指标
主要结局
Pain Intensity (VAS)(Visual Analog Scale )
时间窗: Baseline and post-intervention (week 4)
Measured using the Visual Analog Scale (0-10 ), where 0 indicates no pain and 10 indicates worst possible pain.
Pain Pressure Threshold (Algometer)
时间窗: Measurements were taken pre- and post-intervention. (week 4)
Measured using a digital algometer (kg/cm²) at trigger point sites to assess pain sensitivity.
Pain Intensity (VAS)(Visual Analog Scale )
时间窗: Baseline and post-intervention (week 4)
Measured using the Visual Analog Scale (0-10 ), where 0 indicates no pain and 10 indicates worst possible pain.
Number of Trigger points
时间窗: Measurements were taken pre- and post-intervention.(week 4)
Count of active and latent trigger points in the upper trapezius muscle, assessed by palpation.
Neck Function (CNFDS(Copenhagen Neck Functional Disability)
时间窗: Measurements were taken pre- and post-intervention. (week 4)
Assessed using the Copenhagen Neck Functional Disability Scale, evaluating neck-related disability (0-30, higher scores indicate greater disability).
WHO-5(World Health Organization-Five Well-Bing Index)
时间窗: Measurements were taken pre- and post-intervention. (week 4)
Description: Measured using the WHO-5 Well-Being Index, a 5-item scale (0-25, higher scores indicate better well-being)
次要结局
未报告次要终点
研究者
Shahla Hassanilar Ansaroudi
Principal Investigator,Mcs. Physiotherapy and Rehabilitation Department ,Bahçeşehir University
Bahçeşehir University