Autonomic Nervous System Dysregulation in People With Chronic Neck Pain

December 9, 2025 updated by: National Yang Ming Chiao Tung University

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

Completed

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

Observational

Enrollment (Actual)

56

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Taipei, Taiwan, 112
        • National Yang-Ming University, Taiwan, R.O.C.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The study population consists of healthy participants with or without chronic neck pain, recruited in Taipei.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Ray-Yau Wang, National Yang Ming Chiao Tung University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 29, 2024

Primary Completion (Actual)

October 26, 2025

Study Completion (Actual)

October 27, 2025

Study Registration Dates

First Submitted

August 12, 2024

First Submitted That Met QC Criteria

August 12, 2024

First Posted (Actual)

August 15, 2024

Study Record Updates

Last Update Posted (Actual)

December 10, 2025

Last Update Submitted That Met QC Criteria

December 9, 2025

Last Verified

July 1, 2024

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

No

Studies a U.S. FDA-regulated device product

No

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.

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