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临床试验/NCT07452237
NCT07452237尚未招募不适用

Effects of Transcutaneous Neuromodulation and Cervical Exercise in Students With Chronic Nonspecific Cervical Pain

Universidad Francisco de Vitoria0 个研究点目标入组 51 人开始时间: 2026年4月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
51
主要终点
Pain Intensity

研究概览

简要总结

This randomized controlled trial aims to compare the effectiveness of a cervical exercise program, transcutaneous neuromodulation of the spinal accessory nerve, and a placebo intervention on pain intensity, pressure pain threshold, cervical proprioception, functional disability, depression, anxiety, and stress in university students with chronic non-specific neck pain. The study will include a six-week intervention period with pre- and post-treatment assessments. The findings may contribute to the development of accessible physiotherapy interventions within university settings.

详细描述

Chronic non-specific neck pain is one of the most prevalent musculoskeletal disorders worldwide and represents a significant socioeconomic burden. It affects a large proportion of the adult population and shows increasing prevalence among university students, largely associated with prolonged electronic device use and sustained static postures. Chronic neck pain is defined as pain lasting three months or longer without a specific identifiable pathology.

Psychosocial factors such as stress, anxiety, and depression have been strongly associated with the onset and persistence of neck pain. These factors may contribute to functional disability and reduced quality of life. In university students, persistent neck pain may also negatively impact concentration and academic performance.

Exercise therapy targeting deep cervical flexor muscles has demonstrated improvements in pain, muscular endurance, posture, and functional outcomes in individuals with chronic non-specific neck pain. Additionally, prolonged upper trapezius muscle spasm and possible involvement of the spinal accessory nerve have been suggested as contributing mechanisms in chronic neck pain. Low-frequency electrical stimulation (below 10 Hz), particularly at 4 Hz, has been associated with analgesic effects mediated by endogenous opioid mechanisms.

Placebo interventions have also been shown to activate endogenous analgesic pathways involving cortical and subcortical pain modulation circuits, emphasizing the relevance of patient expectations in rehabilitation outcomes.

This study will compare cervical exercise, transcutaneous neuromodulation of the spinal accessory nerve, and a placebo intervention in a randomized, controlled, parallel-group design with blinded outcome assessment. Both physical and psychosocial variables will be evaluated before and after a six-week intervention period.

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)

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • University students aged 18-30 years
  • Chronic non-specific neck pain lasting ≥ 3 months
  • Pain intensity >3/10 on VAS
  • No pharmacological or physiotherapy treatment in the past 3 months

排除标准

  • Specific cervical pathology (e.g., radiculopathy)
  • Neurological, cardiovascular, systemic, or infectious disease
  • Diagnosed psychological disorders
  • Pregnancy or postpartum period < 1 year
  • Regular use of analgesics, opioids, or antidepressants
  • Previous cervical spine or shoulder surgery
  • Electronic implants
  • Neck pain associated with vertigo

研究组 & 干预措施

Supervised Cervical Exercise Program

Experimental

Participants will perform a supervised cervical and scapular strengthening program focused on deep cervical flexor activation and motor control. The intervention will consist of 12 sessions over six weeks (two sessions per week). Exercises will include cranio-cervical flexion movements, isometric contractions in supine, prone, and side-lying positions, and progressive load adjustments guided by the Borg Rating of Perceived Exertion Scale (target intensity 7/10). Load progression will be implemented after week three to maintain training intensity.

干预措施: Supervised Cervical Exercise Program (Other)

Low-Frequency Transcutaneous Neuromodulation

Experimental

Participants will receive low-frequency electrical stimulation applied bilaterally over the spinal accessory nerve at Erb's point using the Pointer Excel II device. Stimulation parameters will be set at 4 Hz for 5 minutes per side during each session. The intervention will be delivered twice weekly for six weeks.

干预措施: Low-Frequency Transcutaneous Neuromodulation (Device)

Sham Transcutaneous Neuromodulation

Sham Comparator

Participants will undergo a simulated neuromodulation procedure using the same device and positioning as the active neuromodulation group. No electrical current will be delivered. The device will remain in point-detection mode to produce sound without stimulation. The duration and frequency of sessions will match the active intervention group.

干预措施: Sham Transcutaneous Neuromodulation (Device)

结局指标

主要结局

Pain Intensity

时间窗: Baseline and week 6

Pain intensity will be assessed using a 0-10 Visual Analog Scale, where 0 represents no pain and 10 represents the worst imaginable pain.

次要结局

  • Pressure Pain Threshold(Baseline and week 6)
  • Joint Position Sense Error(Baseline and Week 6)
  • Neck Disability(Baseline and week 6)
  • Depression, anxiety and stress(Baseline and week 6)

研究者

发起方
Universidad Francisco de Vitoria
申办方类型
Other
责任方
Principal Investigator
主要研究者

Alberto Roldán

Principal Investigator

Universidad Francisco de Vitoria

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