Clinical trial NCT06450483: Compare the Effects of Different AVNS Parameters on Neck Pain, HRV, Balance in Collegiate Atheletes
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neck Pain
Heart Rate Variability
Balance
Keywords: AVNS
HRV
Balance
Neck Pain
Collegiate athletes
Lead sponsor: University of Sharjah
Sponsor class: OTHER
First posted: 2024-06-10
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 26
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Random allocation of two groups
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Neck pain
timeFrame: up to 6 weeks
measure: Neck pain disability
timeFrame: up to 6 weeks
measure: Balance
timeFrame: up to 6 weeks
measure: Heart Rate
timeFrame: up to 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Sharjah
country: United Arab Emirates
facility: University of Sharjah
Study officials:
affiliation: Associate professor
name: Tamer M Shousha, PhD
role: PRINCIPAL_INVESTIGATOR
References: