Chronic Low Back Pain (CLBP)NCT06760390
Autonomic Differences in Heart Rate Variability Between Healthy and Chronic Low Back Pain Subjects
An observational study of Chronic Low Back Pain (CLBP) and Heart Rate Variability, run by Universidad de Extremadura at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Low Back Pain (CLBP), Heart Rate Variability, Autonomic Nervous System Dysfunction
- How many people
- 98 participants
- Where
- 1 siteSpain
- Study dates
- 1 Nov 2020to 30 Nov 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cross-Sectional Analysis of Autonomic Differences in Heart Rate Variability Between Healthy Individuals and Subjects with Chronic Low Back Pain
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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. | |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Root Mean Square of Successive Differences (rMSSD)
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.
Measured: Measured during a single 30-minute session, including a 5-minute baseline and 25-minute data collection period.
SD1 (Short-Term Variability)
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.
Measured: Measured during a single 30-minute session, including a 5-minute baseline and 25-minute data collection period.
SD2 (Long-Term Variability)
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.
Measured: Measured during a single 30-minute session, including a 5-minute baseline and 25-minute data collection period.
Stress Score (SS)
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.
Measured: Measured during a single 30-minute session, including a 5-minute baseline and 25-minute data collection period.
Sympathetic/Parasympathetic Ratio (S/PS Ratio)
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.
Measured: Measured during a single 30-minute session, including a 5-minute baseline and 25-minute data collection period.
Secondary outcomes (3)
Mean Heart Rate (Mean HR)
Represents the average heart rate (beats per minute) recorded during the data collection period. It serves as a general indicator of autonomic activity, providing insights into the balance between sympathetic and parasympathetic modulation.
Measured: Measured during a single 30-minute session, including a 5-minute baseline and 25-minute data collection period.
Minimum Heart Rate (Min HR)
Represents the lowest heart rate (beats per minute) recorded during the data collection period. This variable reflects periods of parasympathetic predominance and is useful for assessing vagal
Measured: Measured during a single 30-minute session, including a 5-minute baseline and 25-minute data collection period.
Maximum Heart Rate (Max HR)
Represents the highest heart rate (beats per minute) recorded during the data collection period. This variable reflects periods of sympathetic activation and provides insights into stress responses during the session.
Measured: Measured during a single 30-minute session, including a 5-minute baseline and 25-minute data collection period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2025
- Study start1 Nov 2020
- Primary completion30 Nov 2020
- Study completion30 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low Back Pain (CLBP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Extremadura
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlos Fernández-Morales, Universidad de Extremadura
- Investigators
- Luis Espejo-Antúnez, Ph.D., Study director, University of Extremadura
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06760390
- Sponsor's protocol ID
- 08
- Status last verified
- Dec 2024
- First submitted
- 29 Dec 2024
- Last updated
- 6 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-Sectional Analysis of Autonomic Differences in Heart Rate Variability Between Healthy Individuals and Subjects with Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT06760390
- Acronym / sponsor ID
- 08
- Conditions
- Chronic Low Back Pain (CLBP), Heart Rate Variability, Autonomic Nervous System Dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Universidad de ExtremaduraUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 6 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- Adults aged between 18 and 65 years.
- 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).
- Absence of any chronic or acute pathology.
- No regular medication that could alter autonomic nervous system function.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Root Mean Square of Successive Differences (rMSSD)
Time frame: 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.
SD1 (Short-Term Variability)
Time frame: 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.
SD2 (Long-Term Variability)
Time frame: 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)
Time frame: 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)
Time frame: 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.
3 secondary outcomes
Mean Heart Rate (Mean HR)
Time frame: Measured during a single 30-minute session, including a 5-minute baseline and 25-minute data collection period.
Minimum Heart Rate (Min HR)
Time frame: Measured during a single 30-minute session, including a 5-minute baseline and 25-minute data collection period.
Maximum Heart Rate (Max HR)
Time frame: Measured during a single 30-minute session, including a 5-minute baseline and 25-minute data collection period.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luis Espejo-Antúnez, Ph.D. study director
University of Extremadura
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Low Back Pain (CLBP) and Heart Rate Variability, run by Universidad de Extremadura at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Root Mean Square of Successive Differences (rMSSD) (time frame: Measured during a single 30-minute session, including a 5-minute baseline and 25-minute data collection period.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2025.