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Comparative Analysis of Heart Rate Variability in Patients with Cervical Pain, Lumbar Pain, and Healthy Controls

Comparative Analysis of Heart Rate Variability in Patients with Cervical Pain, Lumbar Pain, and Healthy Controls

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06890793
Enrollment
93
Registered
2025-03-24
Start date
2020-01-15
Completion date
2022-12-11
Last updated
2025-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autonomic Nervous System Dysfunction, Chronic Low Back Pain (CLBP), Chronic Neck Pain, Heart Rate Variability

Brief summary

This is a cross-sectional study designed to evaluate potential differences in heart rate variability (HRV) indices based on the affected body region (cervical vs lumbar) in individuals with chronic pain. The study will compare HRV parameters between three groups: individuals with chronic neck pain (CNP), individuals with chronic low back pain (CLBP), and a control group without pain. HRV will be assessed using a Firstbeat Bodyguard® device over a 10-minute period, and the data will be analyzed with Kubios® HRV software. The study aims to determine whether autonomic nervous system modulation differs depending on the location of chronic pain.

Interventions

None listed

Sponsors

Universidad de Extremadura
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* \- Adults aged between 18 and 65 years. For the chronic low back pain group: * Diagnosis of chronic neck or low back pain lasting at least three months. * A minimum pain intensity of 3/10 on the Numerical Pain Rating Scale (NPRS). For the healthy group: * Absence of any chronic or acute pathology. * No regular medication that could alter autonomic nervous system function. * No episodes of low back pain in the past six months.

Exclusion criteria

* Presence of uncontrolled neurological or cardiac disorders. * Use of medications that could influence autonomic function or pain perception (e.g., opioids, antidepressants, benzodiazepines, anti-inflammatory drugs, beta-blockers) within two weeks prior to the study. * Body Mass Index (BMI) equal to or greater than 30 kg/m².

Design outcomes

Primary

MeasureTime frameDescription
Sympathetic/Parasympathetic Ratio (S/PS Ratio)Measured during a single 30-minute session, including a 5-minute baseline and 25-minute data collection period.This variable represents the ratio of Stress Score to SD1. It reflects the balance between sympathetic and parasympathetic modulation, with higher values indicating sympathetic dominance, commonly observed in chronic pain conditions.
Standard Deviation 1 (SD1)Measured during a single 30-minute session, including a 5-minute baseline and 25-minute data collection period.A non-linear metric derived from the Poincaré plot of heart rate variability, indicating short-term variability in R-R intervals. It is closely associated with parasympathetic activity and vagal modulation.
Standard Deviation 2 (SD2)Measured during a single 30-minute session, including a 5-minute baseline and 25-minute data collection period.A non-linear metric derived from the Poincaré plot, representing long-term variability in R-R intervals. SD2 is inversely related to sympathetic activity and reflects the balance between sympathetic and parasympathetic modulation.
Stress Score (SS)Measured during a single 30-minute session, including a 5-minute baseline and 25-minute data collection period.This variable is calculated as the reciprocal of SD2, multiplied by 1000. It reflects the level of sympathetic activation, where higher Stress Score values indicate increased stress and reduced parasympathetic activity.
Root Mean Square of Successive Differences (rMSSD)Measured during a single 30-minute session, including a 5-minute baseline and 25-minute data collection period.This variable represents a time-domain measure of heart rate variability, reflecting parasympathetic nervous system activity and short-term variability in R-R intervals. It is calculated as the root mean square of differences between successive R-R intervals. rMSSD is an established metric to assess vagal modulation and is sensitive to changes in autonomic function.

Secondary

MeasureTime frameDescription
Minimum Heart Rate (Min HR)Measured during a single 30-minute session, including a 5-minute baseline and 25-minute data collection period.Represents the lowest heart rate (beats per minute) recorded during the data collection period. This variable reflects periods of parasympathetic predominance and is useful for assessing vagal.
Maximum Heart Rate (Max HR)Measured during a single 30-minute session, including a 5-minute baseline and 25-minute data collection period.Represents the highest heart rate (beats per minute) recorded during the data collection period. This variable reflects periods of sympathetic activation and provides insights into stress responses during the session.
Mean Heart Rate (Mean HR)Measured during a single 30-minute session, including a 5-minute baseline and 25-minute data collection period.Represents the average heart rate (beats per minute) recorded during the data collection period. It serves as a general indicator of autonomic activity, providing insights into the balance between sympathetic and parasympathetic modulation.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026