Compare the Effects of Different AVNS Parameters on Neck Pain, HRV, Balance in Collegiate Atheletes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-26
SponsorUniversity of Sharjah
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Auricular vagus nerve stimulation
DeviceAuricular 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.
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: Auricular vagus stimulation in Group 1Experimental treatment 1 intervention
Group B: Auricular vagus stimulation in Group 2Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Neck pain
Numerical Pain Rating Scale( 0 no pain and 10 severe pain)
Time frame
up to 6 weeks2
Neck pain disability
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)
Time frame
up to 6 weeks3
Balance
Biodex Balance device to measure the dynamic balance test and limits of stability test
Time frame
up to 6 weeks4
Heart Rate
Pulse oximeter
Time frame
up to 6 weeksSponsors and contacts
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Source ClinicalTrials.gov