Neck PainNCT06450483
Compare the Effects of Different AVNS Parameters on Neck Pain, HRV, Balance in Collegiate Atheletes
A study testing Auricular vagus nerve stimulation in people with Neck Pain and Heart Rate Variability, run by University of Sharjah at 1 site in United Arab Emirates.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 26 yearsHealthy volunteers can take part
- Conditions the study is for
- Neck Pain, Heart Rate Variability, Balance
- What is being tested?
- Auricular vagus nerve stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 29 May 2024to 8 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 26 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Arab Emirates1 site, 1 recruiting
- Recruiting
University of Sharjah
Sharjah city
Tamer M Shousha, PhD
About this study
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
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.
Read the 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 :
- Investigate the effect of different AVNS parameters on pain intensity, HRV, and balance in collegiate athletes with neck pain.
- Examine the effects of AVNS on heart rate variability in collegiate athletes.
- 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:
- The International Physical Activity Questionnaire (IPAQ), 1998
- Neck Pain Disability Index Questionnaire (Physio Therapy 1980)
- Biodex Balance System SD (Biodex Medical Systems, Inc
- Conventional TENS (TPN Dual Channel TENS)
- 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
- Being tested
- Auricular vagus nerve stimulation
- Keywords
- AVNS, HRV, Balance, Neck Pain, Collegiate athletes
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auricular vagus nerve stimulationDevice
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Auricular vagus nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neck pain
Numerical Pain Rating Scale( 0 no pain and 10 severe pain)
Measured: 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)
Measured: up to 6 weeks
Balance
Biodex Balance device to measure the dynamic balance test and limits of stability test
Measured: up to 6 weeks
Heart Rate
Pulse oximeter
Measured: up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2024
- Study start29 May 2024
- Primary completion3 Jul 2024 (estimated)
- Study completion8 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Random allocation of two groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sharjah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tamer Mohamed Shousha, University of Sharjah
- Investigators
- Tamer M Shousha, PhD, Principal investigator, Associate professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06450483
- Sponsor's protocol ID
- AVNS on HRV and balance
- Status last verified
- Jun 2024
- First submitted
- 27 May 2024
- Last updated
- 13 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06450483
- Acronym / sponsor ID
- AVNS on HRV and balance
- Conditions
- Neck Pain, Heart Rate Variability, Balance
- Keywords
- AVNS, HRV, Balance, Neck Pain, Collegiate athletes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of SharjahUniversity, hospital or other
- Study start
- 29 May 2024 (actual)
- Primary completion
- 3 Jul 2024 (estimated)
- Study completion
- 8 Jul 2024 (estimated)
- First posted
- 10 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 :
- Investigate the effect of different AVNS parameters on pain intensity, HRV, and balance in collegiate athletes with neck pain.
- Examine the effects of AVNS on heart rate variability in collegiate athletes.
- 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:
- The International Physical Activity Questionnaire (IPAQ), 1998
- Neck Pain Disability Index Questionnaire (Physio Therapy 1980)
- Biodex Balance System SD (Biodex Medical Systems, Inc
- Conventional TENS (TPN Dual Channel TENS)
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Random allocation of two groups
| Arm | Type | Receives |
|---|---|---|
| Auricular vagus stimulation in Group 1 | Experimental | Device: 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 2 | Experimental | Device: 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. |
Who may qualify
- Ages
- 18 to 26 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Auricular vagus nerve stimulationAlso: TPN Dual Channel TENSAuricular 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. | Device | Auricular vagus stimulation in Group 1, Auricular vagus stimulation in Group 2 |
Primary outcome
Neck pain
Time frame: up to 6 weeks
Numerical Pain Rating Scale( 0 no pain and 10 severe pain)
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)
Balance
Time frame: up to 6 weeks
Biodex Balance device to measure the dynamic balance test and limits of stability test
Heart Rate
Time frame: up to 6 weeks
Pulse oximeter
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tamer M Shousha, PhD principal investigator
Associate professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auricular vagus nerve stimulation in people with Neck Pain and Heart Rate Variability, run by University of Sharjah at 1 site in United Arab Emirates.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Arab Emirates. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tamer M Shousha, PhD (+971562224469, tshousha@sharjah.ac.ae), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neck pain (time frame: up to 6 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2024.