Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06450483
Status:
RECRUITING
Last Update Posted:
2024-06-13
First Post:
2024-05-27
Brief Title:
Compare the Effects of Different AVNS Parameters on Neck Pain HRV Balance in Collegiate Atheletes
Sponsor:
University of Sharjah
Organization:
University of Sharjah
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None