Clinical trial NCT06760390: Autonomic Differences in Heart Rate Variability Between Healthy and Chronic Low Back Pain Subjects
Official title: Cross-Sectional Analysis of Autonomic Differences in Heart Rate Variability Between Healthy Individuals and Subjects with Chronic Low Back Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Low Back Pain (CLBP)
Heart Rate Variability
Autonomic Nervous System Dysfunction
Lead sponsor: Universidad de Extremadura
Sponsor class: OTHER
First posted: 2025-01-06
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Root Mean Square of Successive Differences (rMSSD)
timeFrame: Measured during a single 30-minute session, including a 5-minute baseline and 25-minute data collection period.
measure: SD1 (Short-Term Variability)
timeFrame: Measured during a single 30-minute session, including a 5-minute baseline and 25-minute data collection period.
measure: SD2 (Long-Term Variability)
timeFrame: Measured during a single 30-minute session, including a 5-minute baseline and 25-minute data collection period.
measure: Stress Score (SS)
timeFrame: Measured during a single 30-minute session, including a 5-minute baseline and 25-minute data collection period.
measure: Sympathetic/Parasympathetic Ratio (S/PS Ratio)
timeFrame: Measured during a single 30-minute session, including a 5-minute baseline and 25-minute data collection period.
Secondary outcomes:
measure: Mean Heart Rate (Mean HR)
timeFrame: Measured during a single 30-minute session, including a 5-minute baseline and 25-minute data collection period.
measure: Minimum Heart Rate (Min HR)
timeFrame: Measured during a single 30-minute session, including a 5-minute baseline and 25-minute data collection period.
measure: Maximum Heart Rate (Max HR)
timeFrame: Measured during a single 30-minute session, including a 5-minute baseline and 25-minute data collection period.
Other outcomes:
Locations:
city: Badajoz
country: Spain
facility: Universidad de Extremadura
Study officials:
affiliation: University of Extremadura
name: Luis Espejo-Antúnez, Ph.D.
role: STUDY_DIRECTOR
References: