Comparative Analysis of Heart Rate Variability in Patients with Cervical Pain, Lumbar Pain, and Healthy Controls
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 93
- 试验地点
- 1
- 主要终点
- Root Mean Square of Successive Differences (rMSSD)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •- 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.
排除标准
- •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.
结局指标
主要结局
Root Mean Square of Successive Differences (rMSSD)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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.
次要结局
- 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.)
研究者
Carlos Fernández-Morales
Clinical Professor
Universidad de Extremadura