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

June 12, 2024 updated by: Tamer Mohamed Shousha, University of Sharjah

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United Arab Emirates
      • Sharjah, United Arab Emirates
        • Recruiting
        • University of Sharjah
        • Contact:
          • Tamer M Shousha, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Auricular vagus stimulation in Group 1
Frequency: 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.
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.

Other Names:
  • TPN Dual Channel TENS
Experimental: Auricular vagus stimulation in Group 2
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.
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.

Other Names:
  • TPN Dual Channel TENS

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sharjah

Investigators

  • Principal Investigator: Tamer M Shousha, PhD, Associate Professor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 29, 2024

Primary Completion (Estimated)

July 3, 2024

Study Completion (Estimated)

July 8, 2024

Study Registration Dates

First Submitted

May 27, 2024

First Submitted That Met QC Criteria

June 3, 2024

First Posted (Actual)

June 10, 2024

Study Record Updates

Last Update Posted (Actual)

June 13, 2024

Last Update Submitted That Met QC Criteria

June 12, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AVNS on HRV and balance

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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