Comparative Analysis of Heart Rate Variability in Patients with Cervical Pain, Lumbar Pain, and Healthy Controls
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 93
- Locations
- 1
- Primary Endpoint
- Root Mean Square of Successive Differences (rMSSD)
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Outcomes
Primary Outcomes
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.
Standard Deviation 1 (SD1)
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.
Standard Deviation 2 (SD2)
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.
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.
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
- 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.)
Investigators
Carlos Fernández-Morales
Clinical Professor
Universidad de Extremadura