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

Neck Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06450483
• Other study ID #: AVNS on HRV and balance
• Status: Recruiting
• Phase: N/A
• Start date: May 29, 2024
• Est. completion date: July 8, 2024

Study information

• Verified date: June 2024
• Source: University of Sharjah
• Contact: Tamer M Shousha, PhD
• Phone: +971562224469
• Email: tshousha[@]sharjah.ac.ae
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: July 8, 2024
• Est. primary completion date: July 3, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 26 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Balance
• Heart Rate Variability
• Neck Pain

Intervention

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.

Locations

Country	Name	City	State
United Arab Emirates	University of Sharjah	Sharjah

Sponsors (1)

Lead Sponsor	Collaborator
University of Sharjah

Country where clinical trial is conducted

United Arab Emirates, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neck pain	Numerical Pain Rating Scale( 0 no pain and 10 severe pain)	up to 6 weeks
Primary	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)	up to 6 weeks
Primary	Balance	Biodex Balance device to measure the dynamic balance test and limits of stability test	up to 6 weeks
Primary	Heart Rate	Pulse oximeter	up to 6 weeks