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

NCT06450483 | Recruiting

• 1 other identifier: AVNS on HRV and balance
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Neck Pain; Heart Rate Variability; Balance

Keywords

AVNS; HRV; Balance; Neck Pain; Collegiate athletes

Outcome Measures

Primary Outcomes (4)

• Neck pain

  Numerical Pain Rating Scale( 0 no pain and 10 severe pain)

  up to 6 weeks

• 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

• Balance

  Biodex Balance device to measure the dynamic balance test and limits of stability test

  up to 6 weeks

• Heart Rate

  Pulse oximeter

  up to 6 weeks

Study Arms (2)

Auricular vagus stimulation in Group 1

EXPERIMENTAL

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 vagus stimulation in Group 2

EXPERIMENTAL

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

Interventions

Auricular vagus nerve stimulation DEVICE

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.

Also known as: TPN Dual Channel TENS

Auricular vagus stimulation in Group 1; Auricular vagus stimulation in Group 2

Eligibility Criteria

• Age: 18 Years - 26 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sharjah: lead

Study Sites (1)

University of Sharjah

Sharjah city, United Arab Emirates

RECRUITING

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Tamer M Shousha, PhD

  Associate professor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tamer M Shousha, PhD

CONTACT

+971562224469; tshousha@sharjah.ac.ae

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: the participants were masked in regards to the group they are in
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Random allocation of two groups

Study Record Dates

• First Submitted: May 27, 2024
• First Posted: June 10, 2024
• Study Start: May 29, 2024
• Primary Completion: July 3, 2024
• Study Completion: July 8, 2024
• Last Updated: June 13, 2024

Record last verified: 2024-06

Locations

AE (1)