Comparing the Effects of Different Auricular Vagus Nerve Stimulation (AVNS) Parameters on Neck Pain Intensity, Heart Rate Variability (HRV), and Balance in Collegiate Athletes: A Randomized Comparative Effectiveness Design
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Neck pain
研究概览
简要总结
This study looks at how auricular vagus nerve stimulation (AVNS) affects neck pain, heart rate variability, and balance in college athletes, additionally, if different settings of auricular vagus nerve stimulation (AVNS) affect neck pain, heart rate variability, and balance in college athletes. The participants will be split into two groups, each receiving AVNS with different settings.
The study hypothesizes that vagus nerve stimulation (VNS) will reduce pain perception in college athletes. It is expected that auricular vagus nerve stimulation (AVNS) will decrease heart rate variability (HRV) in this population. Additionally, it is anticipated that college athletes undergoing AVNS will exhibit improved balance. The Investigators also believe that AVNS will decrease neck pain and enhance neck function. Finally, it is proposed that different AVNS parameters will have varying effects on pain intensity, HRV, and balance in collegiate athletes.
详细描述
This study investigated whether AVNS affects pain intensity, HRV, and balance in collegiate athletes with neck pain. Additionally, whether different AVNS parameters have different effects on pain intensity, HRV, and balance in collegiate athletes with neck pain? the objective of the study is to :
- Investigate the effect of different AVNS parameters on pain intensity, HRV, and balance in collegiate athletes with neck pain.
- Examine the effects of AVNS on heart rate variability in collegiate athletes.
- Examine the effect of AVNS on balance in collegiate athletes.
The participants are assigned to two groups receiving distinct AVNS parameter sets. The study used five tools:
- The International Physical Activity Questionnaire (IPAQ), 1998
- Neck Pain Disability Index Questionnaire (Physio Therapy 1980)
- Biodex Balance System SD (Biodex Medical Systems, Inc
- Conventional TENS (TPN Dual Channel TENS)
- Pulse Oximeter
Intervention Group 1: Participants in this category will undergo an auricular vagus nerve stimulation using the following parameters: Frequency: 25 Hz applied on the tragus of the ear, pulse length: 250 μs. Intervention Group 2: Participants in this category will undergo an auricular vagus nerve stimulation but with slightly different parameters: Frequency: 10 Hz on the tragus of the ear, pulse length: 250 μs. A total of 4 sessions (2 sessions for 2 weeks). The sessions will be consistent with every participant where they will be given their sessions on the same days every week.
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 (Participant)
盲法说明
the participants were masked in regards to the group they are in
入排标准
- 年龄范围
- 18 Years 至 26 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Gender: Male and female Healthy collegiate athletes based in UAE
- •Age range: 18-26 years
- •Physical activity level: High score on the International Physical Activity Questionnaire
- •BMI: Within the range of 20-25
- •Neck pain level: Mild to moderate score on the Neck Pain Disability Index Questionnaire
排除标准
- •Recent injury: Had an injury within the last three months
- •Age: Over 26 years or below 18 years
- •Physical activity level: Scored moderate or low on the International Physical Activity Questionnaire
- •BMI: Above 25 or below 20
- •Neck pain level: Scored severe on the Neck Pain Disability Index Questionnaire
结局指标
主要结局
Neck pain
时间窗: up to 6 weeks
Numerical Pain Rating Scale( 0 no pain and 10 severe pain)
Heart Rate
时间窗: up to 6 weeks
Pulse oximeter
Neck pain disability
时间窗: up to 6 weeks
Neck pain disability Index (0-4:No Disability, 5-14:Mild Disability,15-24:Moderate Disability,25-34:Severe Disability, and above 34: Complete Disability)
Balance
时间窗: up to 6 weeks
Biodex Balance device to measure the dynamic balance test and limits of stability test
次要结局
未报告次要终点
研究者
Tamer Mohamed Shousha
Associate Professor
University of Sharjah