Comparative Analysis of Heart Rate Variability in Patients with Cervical Pain, Lumbar Pain, and Healthy Controls

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

93 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-15

Study Completion Date

2022-12-11

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

HRV and Pain Intensity

NCT04539353

Chronic Pain

UNKNOWN

Effectiveness of Neuroscience-based Pain Education in Patients With Chronic Neck Pain

NCT06320938

Cervical Spine Disease

COMPLETED NA

Effects of Multimodal Exercises Integrated With Cognitive-behavioral Therapy in Subjects With Chronic Neck Pain

NCT04768790

Neck Pain

SUSPENDED NA

Sensory Characteristics and Psychosocial Factors Related With Non-specific Neck Musculoskeletal Pain Chronification

NCT04330573

Neck Pain

COMPLETED

Association Between Types of Pain and Motor Activities Physical Activity

NCT05236933

Spinal Cord Injury Chronic Pain

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Chronic Neck Pain Subjects

This group includes adults aged 18-65 years diagnosed with chronic neck 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

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes