- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06554704
Autonomic Nervous System Dysregulation in People With Chronic Neck Pain
Autonomic Nervous System Dysregulation in People With Chronic Neck Pain - Indicated by Heart Rate Variability
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?
Study Overview
Status
Conditions
Intervention / Treatment
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 LF/HF 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 < 0.05.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Taipei, Taiwan, 112
- National Yang-Ming University, Taiwan, R.O.C.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Chronic neck pain inclusion criteria:
- Chronic pain (persistent or recurrent pain >90 days)
- Non-specific chronic neck pain and non-irradiated to the upper limbs (Superior nuchal line ~ scapular spine ~ acromion)
Chronic neck pain & healthy control inclusion criteria:
- Age- and gender- matched (age: 20~59 y/o)
- BMI between 18.5~24.9 (Normal weight)
- Work at least 75% of full-time work
Exclusion criteria:
- Neurological diseases
- Orthopedic disorders
- Other disorders or regular use of medications known to affect physical activity, autonomic nervous system or pain perception
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Chronic neck pain
Individuals with non-specific chronic neck pain
|
The five-minute heart rate variability and respiration rate will be measured for each condition including resting in supine, sitting and standing position, as well as the isometric hand grip test in supine, sitting and standing position.
|
|
Healthy control
Individuals without non-specific chronic neck pain
|
The five-minute heart rate variability and respiration rate will be measured for each condition including resting in supine, sitting and standing position, as well as the isometric hand grip test in supine, sitting and standing position.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Heart rate variability
Time Frame: Five-minute
|
Time domain and frequency domain indices
|
Five-minute
|
Collaborators and Investigators
Investigators
- Principal Investigator: Ray-Yau Wang, National Yang Ming Chiao Tung University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NYCU113077AE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chronic Neck Pain
-
The Hong Kong Polytechnic UniversityNot yet recruitingChronic Neck Pain | Neck Pain Treatment | Neck Pain ChronicHong Kong
-
Universitat Internacional de CatalunyaNot yet recruitingChronic Neck Pain | Non-specific Neck PainSpain
-
Hacettepe UniversityNot yet recruitingChronic Neck PainTurkey (Türkiye)
-
Massachusetts General HospitalCompletedChronic Low Back Pain | Chronic Neck PainUnited States
-
Hochschule OsnabruckNot yet recruitingNeck Pain | Chronic Neck Pain | Neck Disability | Neck Pain Musculoskeletal | Neck Disease
-
KTO Karatay UniversityRecruitingChronic Neck PainTurkey (Türkiye)
-
Foundation University IslamabadNot yet recruiting
-
Universidad Europea de MadridCompletedChronic Neck PainSpain
-
Kirsehir Ahi Evran UniversitesiCompletedChronic Neck PainTurkey (Türkiye)
-
The University of Hong KongCompletedChronic Low Back Pain | Chronic Neck PainHong Kong
Clinical Trials on Isometric hand grip test
-
University of PernambucoUnknownHypertension | Obstructive Sleep ApneaBrazil
-
Mansoura UniversityCompletedEnd-Stage Renal Disease | Arteriovenous Fistula | Chronic Kidney FailureEgypt
-
Riphah International UniversityCompletedDevelopmental DelayPakistan
-
Hospital General Universitario Gregorio MarañonSpanish Society of NephrologyCompletedArteriovenous Fistula Stenosis | Arteriovenous Fistula ThrombosisSpain
-
Lawson Health Research InstituteUniversity of WindsorNot yet recruiting
-
University of MichiganTerminated
-
Yonsei UniversityRecruitingPatients Undergoing Minimally Invasive Pylorus Preserving PancreaticoduodenectomyKorea, Republic of
-
Guangdong Provincial People's HospitalCompleted
-
Beni-Suef UniversityCompletedType II Diabetes MellitusEgypt
-
Riphah International UniversityCompleted