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Completed

NCT Number: NCT06760390

Autonomic Differences in Heart Rate Variability Between Healthy and Chronic Low Back Pain Subjects

This study aims to evaluate the autonomic differences in heart rate variability (HRV) between healthy individuals and those with chronic low back pain. By analyzing HRV parameters, such as time-domain, frequency-domain, and non-linear metrics, this cross-sectional study seeks to explore the impact of chronic pain on the autonomic nervous system. The study will provide insights into parasympathetic and sympathetic modulation and its potential relationship with chronic pain symptoms. Participants include healthy adults and individuals with chronic low back pain aged 18-65.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Universidad de Extremadura

Badajoz, 06006, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults aged between 18 and 65 years.

For the chronic low back pain group:

  • Diagnosis of chronic 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.

Treatment and study plan

Primary outcomes

  1. Root Mean Square of Successive Differences (rMSSD)

    Time frame: 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.

  2. SD1 (Short-Term Variability)

    Time frame: 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.

  3. SD2 (Long-Term Variability)

    Time frame: 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.

  4. Stress Score (SS)

    Time frame: 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.

  5. Sympathetic/Parasympathetic Ratio (S/PS Ratio)

    Time frame: 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.

Secondary outcomes

  1. Mean Heart Rate (Mean HR)

    Time frame: 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.

  2. Minimum Heart Rate (Min HR)

    Time frame: 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

  3. Maximum Heart Rate (Max HR)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Universidad de Extremadura

Other

Registry information

Official study title

Cross-Sectional Analysis of Autonomic Differences in Heart Rate Variability Between Healthy Individuals and Subjects with Chronic Low Back Pain

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jan 6, 2025
Registry last updated
Jan 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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