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

NCT06760390 | Completed

• 1 other identifier: 08
• Study Type: observational
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (5)

• Root Mean Square of Successive Differences (rMSSD)

  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.

  Measured during a single 30-minute session, including a 5-minute baseline and 25-minute data collection period.

• SD1 (Short-Term Variability)

  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.

  Measured during a single 30-minute session, including a 5-minute baseline and 25-minute data collection period.

• SD2 (Long-Term Variability)

  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.

  Measured during a single 30-minute session, including a 5-minute baseline and 25-minute data collection period.

• Stress Score (SS)

  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.

  Measured during a single 30-minute session, including a 5-minute baseline and 25-minute data collection period.

• Sympathetic/Parasympathetic Ratio (S/PS Ratio)

  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.

  Measured during a single 30-minute session, including a 5-minute baseline and 25-minute data collection period.

Secondary Outcomes (3)

• Mean Heart Rate (Mean HR)

  Measured during a single 30-minute session, including a 5-minute baseline and 25-minute data collection period.

• Minimum Heart Rate (Min HR)

  Measured during a single 30-minute session, including a 5-minute baseline and 25-minute data collection period.

• Maximum Heart Rate (Max HR)

  Measured during a single 30-minute session, including a 5-minute baseline and 25-minute data collection period.

Study Arms (2)

Healthy Subjects

This group includes adults aged 18-65 years without any chronic or acute pathology, no regular medication that could alter autonomic nervous system function, and no low back pain in the past six months.

Chronic Low Back Pain Subjects

This group includes adults aged 18-65 years diagnosed with chronic low back pain lasting at least three months, with a minimum pain intensity of 3/10 on the Numerical Pain Rating Scale, and without uncontrolled neurological or cardiac disorders.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study includes two groups: one group of adults diagnosed with chronic low back pain, aged 18-65 years, and another group of healthy adults within the same age range. Participants were recruited from local community advertisements and hospital outpatient clinics.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de Extremadura: lead

Study Sites (1)

Universidad de Extremadura

Badajoz, Badajoz, 06006, Spain

Location

Study Officials

• Luis Espejo-Antúnez, Ph.D.

  University of Extremadura

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: December 29, 2024
• First Posted: January 6, 2025
• Study Start: November 1, 2020
• Primary Completion: November 30, 2020
• Study Completion: November 30, 2020
• Last Updated: January 6, 2025

Record last verified: 2024-12

Locations

ES (1)