Autonomic Differences in Heart Rate Variability Between Healthy and Chronic Low Back Pain Subjects

NCT ID: NCT06760390

Last Updated: 2025-01-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 98 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-11-01
• Study Completion Date: 2020-11-30

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.

Conditions

Chronic Low Back Pain (CLBP); Heart Rate Variability; Autonomic Nervous System Dysfunction

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universidad de Extremadura

OTHER

Sponsor Role: lead

Responsible Party

Carlos Fernández-Morales

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Luis Espejo-Antúnez, Ph.D.

Role: STUDY_DIRECTOR

University of Extremadura

Locations

Universidad de Extremadura

Badajoz, Badajoz, Spain

Countries

Spain

Other Identifiers

08

Identifier Type: -

Identifier Source: org_study_id