NCT06450483

Compare the Effects of Different AVNS Parameters on Neck Pain, HRV, Balance in Collegiate Atheletes

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: University of Sharjah · Academic / Other
• Sex: All
• Age: 18 Years – 26 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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 : 1. Investigate the effect of different AVNS parameters on pain intensity, HRV, and balance in collegiate athletes with neck pain. 2. Examine the effects of AVNS on heart rate variability in collegiate athletes. 3. 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: 1. The International Physical Activity Questionnaire (IPAQ), 1998 2. Neck Pain Disability Index Questionnaire (Physio Therapy 1980) 3. Biodex Balance System SD (Biodex Medical Systems, Inc 4. Conventional TENS (TPN Dual Channel TENS) 5. 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. 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 researchers 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.

Conditions

• Neck Pain
• Heart Rate Variability
• Balance

Interventions

Type	Name	Description
DEVICE	Auricular vagus nerve stimulation	Auricular vagal nerve stimulation using TPN dual channel TENS will be used for the study.The device used to stimulate is a conventional TENS. The stimulation is by applying a clip electrode placed on the tragus of the left ear and a second electrode applied on the left upper trapezius of the participant which will then stimulate the vagus nerve.Auricular vagus nerve stimulation session will be applied for 15 minutes. Participant is seated and relaxed.After the first session ended; heart rate will be measured and recorded once again to see the effect of the VNS. Before the last AVNS session started; heart rate will be measured and recorded. The participants' vagus nerve is then stimulated for 15 minutes.

Timeline

• Start date: 2024-05-29
• Primary completion: 2024-07-03
• Completion: 2024-07-08
• First posted: 2024-06-10
• Last updated: 2024-06-13

Locations

1 site across 1 country: United Arab Emirates