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

NCT06450483 — Not applicable, Unknown, 70 participants, University of Sharjah

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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

RegistryNCT06450483
StatusUnknown
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: single, treatment
Enrollment70 (Estimated)
SponsorUniversity of Sharjah (Other)
ConditionsNeck Pain, Heart Rate Variability, Balance
InterventionsAuricular vagus nerve stimulation (Device)
Datesstart 2024-05-29, primary completion 2024-07-03 (estimated), completion 2024-07-08 (estimated), first posted 2024-06-10, last updated 2024-06-13
Locations1 site in United Arab Emirates

Related Papers Related Patents Related Grants Related Experts
All trials for Neck Pain All trials for Heart Rate Variability All trials of Auricular vagus nerve stimulation

-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Auricular vagus stimulation in Group 1ExperimentalDevice: Auricular vagus nerve stimulationFrequency: 25 Hz applied 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 were given their sessions on the same days every week.
Auricular vagus stimulation in Group 2ExperimentalDevice: Auricular vagus nerve stimulationFrequency: 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.
  • Auricular vagus nerve stimulation (Device), also known as TPN Dual Channel TENS: 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.

+Outcome measures

Primary outcomes

  • Neck pain [up to 6 weeks]: Numerical Pain Rating Scale( 0 no pain and 10 severe pain)
  • Neck pain disability [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 [up to 6 weeks]: Biodex Balance device to measure the dynamic balance test and limits of stability test
  • Heart Rate [up to 6 weeks]: Pulse oximeter

+Eligibility

Sex: All, ages: 18 Years to 26 Years, accepts healthy volunteers

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

+Locations (1)

FacilityCityCountryStatus
University of SharjahSharjah cityUnited Arab EmiratesRecruiting

+Investigators