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

NCT ID: NCT06450483

Last Updated: 2024-06-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-29
• Study Completion Date: 2024-07-08

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.

Conditions

Neck Pain; Heart Rate Variability; Balance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Auricular vagus nerve stimulation

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Auricular vagus nerve stimulation

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

TPN Dual Channel TENS

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 26 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Sharjah

OTHER

Sponsor Role: lead

Responsible Party

Tamer Mohamed Shousha

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tamer M Shousha, PhD

Role: PRINCIPAL_INVESTIGATOR

Associate professor

Locations

University of Sharjah

Sharjah city, , United Arab Emirates

Site Status: RECRUITING

Countries

United Arab Emirates

Central Contacts

Tamer M Shousha, PhD

Role: CONTACT

tshousha@sharjah.ac.ae

+971562224469

Facility Contacts

Tamer M Shousha, PhD

Role: primary

Other Identifiers

AVNS on HRV and balance

Identifier Type: -

Identifier Source: org_study_id