Clinical trial NCT06890793: Comparative Analysis of Heart Rate Variability in Patients with Cervical Pain, Lumbar Pain, and Healthy Controls
Official title: Comparative Analysis of Heart Rate Variability in Patients with Cervical Pain, Lumbar Pain, and Healthy Controls
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Low Back Pain (CLBP)
Chronic Neck Pain
Heart Rate Variability
Autonomic Nervous System Dysfunction
Lead sponsor: Universidad de Extremadura
Sponsor class: OTHER
First posted: 2025-03-24
Enrollment: 93
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 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.

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.


Eligibility criteria: 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.

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: Standard Deviation 1 (SD1)
timeFrame: Measured during a single 30-minute session, including a 5-minute baseline and 25-minute data collection period.
measure: Standard Deviation 2 (SD2)
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: