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

NCT06890793 | Completed

• 1 other identifier: 09
• Study Type: observational
• Target: 93
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Low Back Pain (CLBP); Chronic Neck Pain; 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.

• Standard Deviation 1 (SD1)

  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.

• Standard Deviation 2 (SD2)

  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 (3)

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.

Chronic Neck Pain Subjects

This group includes adults aged 18-65 years diagnosed with chronic neck 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 will include three groups: one group of adults diagnosed with chronic neck pain (CNP), one group of adults diagnosed with chronic low back pain (CLBP), and another group of healthy adults within the same age range. Participants will be 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 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.

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: March 17, 2025
• First Posted: March 24, 2025
• Study Start: January 15, 2020
• Primary Completion: December 11, 2022
• Study Completion: December 11, 2022
• Last Updated: March 26, 2025

Record last verified: 2025-03

Locations

ES (1)