Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06554704
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-12
Brief Title:
Autonomic Nervous System Dysregulation in People With Chronic Neck Pain
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Autonomic Nervous System Dysregulation in People With Chronic Neck Pain - Indicated by Heart Rate Variability
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this observational study is to investigate heart rate variability in different positions and in response to isometric hand-grip test in people with non-specific chronic neck pain as compared with healthy controls The main questions it aims to answer are
Do the heart rate variability indices differ between people with non-specific chronic neck pain and healthy controls in supine sitting and standing positions
Do the heart rate variability indices differ between people with non-specific chronic neck pain and healthy controls when challenged by the isometric hand-grip test
Do the heart rate variability indices differ between people with non-specific chronic neck pain and healthy controls in supine sitting and standing positions
Do the heart rate variability indices differ between people with non-specific chronic neck pain and healthy controls when challenged by the isometric hand-grip test
Detailed Description:
Background Chronic neck pain CNP is a common symptom that affects the neck region with persistent or recurrent pain for more than 3 months Ninety percent of people experience CNP is non-specific meaning the underlying cause is not clear or specific CNP is associated with risk factors that potentially induce sustained physiological responses The autonomic nervous system ANS is responsible for controlling physiological functions and is required to adaptively respond to physical and mental stress The risk factors may lead to ANS dysregulation and decrease capacity to cope with sensory and emotional stress The ANS regulation can be measured through the assessment of heart rate variability HRV However limited number of studies have documented the ANS dysregulation in people with CNP The aim of present study is to investigate HRV in different positions and in response to isometric hand-grip IHG test in people with non-specific CNP as compared with healthy controls HC
Methods This is an observational cross-sectional study Twenty-eight participants with non-specific CNP and 28 age- and gender-matched HC will be recruited The 5-min HRV and respiration rate will be measured for each condition including resting in supine sitting and standing position as well as the IHG test in supine sitting and standing position The 3-lead electrocardiography ECG data will be collected and analyzed for HRV indices including time domain mean R-R interval standard deviation of the normal-to-normal interval and root mean square successive difference and frequency domain low frequency LF high frequency HF and LFHF ratio Statistical analysis Descriptive data are presented as mean with standard deviation or frequency Group differences in subject characteristics are analyzed using independent t-test or Chi-square test Two-way mixed analyses of covariance ANCOVAs are used to assess HRV indices between groups and conditions with Tukey post hoc analysis The maximal voluntary contraction of IHG test pain intensity indicated by numeric rating scale and respiratory rate will be used as covariates The significant level is set at p 005
Methods This is an observational cross-sectional study Twenty-eight participants with non-specific CNP and 28 age- and gender-matched HC will be recruited The 5-min HRV and respiration rate will be measured for each condition including resting in supine sitting and standing position as well as the IHG test in supine sitting and standing position The 3-lead electrocardiography ECG data will be collected and analyzed for HRV indices including time domain mean R-R interval standard deviation of the normal-to-normal interval and root mean square successive difference and frequency domain low frequency LF high frequency HF and LFHF ratio Statistical analysis Descriptive data are presented as mean with standard deviation or frequency Group differences in subject characteristics are analyzed using independent t-test or Chi-square test Two-way mixed analyses of covariance ANCOVAs are used to assess HRV indices between groups and conditions with Tukey post hoc analysis The maximal voluntary contraction of IHG test pain intensity indicated by numeric rating scale and respiratory rate will be used as covariates The significant level is set at p 005
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None