Chronic PainNCT04539353
HRV and Pain Intensity
An observational study of Chronic Pain, run by Moens Maarten at 2 sites in Belgium.
Trial summary
The aim of this study is to explore the association between pain intensity and heart rate variability in patients with chronic pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Heart Rate Variability and Pain intensity
- How many people
- 200 participants
- Where
- 2 sitesBelgium
- Study dates
- 14 Dec 2020to 15 Oct 2021
- 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 years and older
- All sexes
- Adult, Older adult
Study population: Chronic pain patients (regardless of the cause of the pain).
Who may be able to join
- Patients with chronic pain for at least 3 months
- Age > 18 years
- Patient has been informed of the study procedures and has given written informed consent
- Patient willing to comply with study protocol
Who cannot join
- Healthy patients or patients with acute pain.
- Evidence of an active disruptive psychiatric disorder that may impact perception of pain, and/or ability to evaluate treatment outcome as determined by investigator
- Patients were excluded if they had one or more coexisting conditions known to affect HRV analysis.
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites, 2 recruiting
- Recruiting
Universitair Ziekenhuis Brussel
Jette, 1090
Maarten Moens, Prof. dr.
- Recruiting
AZ Delta
Roeselare, 8800
Bart Billet, dr.
About this study
Official title: The Association Between Pain Intensity and Heart Rate Variability in Chronic Pain Patients.
The aim of this study is to explore the association between pain intensity and heart rate variability in patients with chronic pain.
- Conditions
- Chronic Pain
- Being tested
- Heart Rate Variability, Pain intensity
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heart Rate VariabilityOther
Heart Rate Variability will be measured with a Polar device.
Pain intensityOther
Pain Intensity will be measured with a Numeric Rating Scale and Visual Analogue Scale
| Study group | Role | What they receive |
|---|---|---|
| chronic pain | Patients with chronic pain, regardless of the cause of the pain. Receives: Other: Heart Rate Variability; Other: Pain intensity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Rate Variability
Heart Rate Variability will be measured with a Polar device during a 5 minute recording.
Measured: During study visit, cross-sectional, once, during 5 minutes.
Pain Intensity with Numeric Rating Scale
Pain Intensity will be measured with a Numeric Rating Scale.
Measured: During study visit, cross-sectional, once.
Pain Intensity with Visual Analogue Scale
Pain Intensity will be measured with a Visual Analogue Scale.
Measured: During study visit, cross-sectional, once.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2020
- Study start14 Dec 2020
- Primary completion15 Oct 2021 (estimated)
- Study completion15 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Moens Maarten
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Moens Maarten, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04539353
- Sponsor's protocol ID
- INTERVAL
- Status last verified
- Feb 2021
- First submitted
- 26 Aug 2020
- Last updated
- 25 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Moens M, Billet B, Molenberghs G, De Smedt A, Pilitsis JG, De Vos R, Hanssens K, Billot M, Roulaud M, Rigoard P, Goudman L. Heart rate variability is not suitable as a surrogate marker for pain intensity in patients with chronic pain. Pain. 2023 Aug 1;164(8):1741-1749. doi: 10.1097/j.pain.0000000000002868. Epub 2023 Jan 19.
PubMed 36722463
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association Between Pain Intensity and Heart Rate Variability in Chronic Pain Patients.
- ClinicalTrials.gov ID
- NCT04539353
- Acronym / sponsor ID
- INTERVAL
- Conditions
- Chronic Pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Moens MaartenUniversity, hospital or other
- Study start
- 14 Dec 2020 (actual)
- Primary completion
- 15 Oct 2021 (estimated)
- Study completion
- 15 Oct 2021 (estimated)
- First posted
- 7 Sep 2020 (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.
The aim of this study is to explore the association between pain intensity and heart rate variability in patients with chronic pain.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| chronic pain | – | Other: Heart Rate Variability, Other: Pain intensityPatients with chronic pain, regardless of the cause of the pain. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Chronic pain patients (regardless of the cause of the pain).
Key inclusion criteria (4 listed)
- Patients with chronic pain for at least 3 months
- Age > 18 years
- Patient has been informed of the study procedures and has given written informed consent
- Patient willing to comply with study protocol
Key exclusion criteria (3 listed)
- Healthy patients or patients with acute pain.
- Evidence of an active disruptive psychiatric disorder that may impact perception of pain, and/or ability to evaluate treatment outcome as determined by investigator
- Patients were excluded if they had one or more coexisting conditions known to affect HRV analysis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heart Rate VariabilityHeart Rate Variability will be measured with a Polar device. | Other | chronic pain |
| Pain intensityPain Intensity will be measured with a Numeric Rating Scale and Visual Analogue Scale | Other | chronic pain |
Primary outcome
Heart Rate Variability
Time frame: During study visit, cross-sectional, once, during 5 minutes.
Heart Rate Variability will be measured with a Polar device during a 5 minute recording.
Pain Intensity with Numeric Rating Scale
Time frame: During study visit, cross-sectional, once.
Pain Intensity will be measured with a Numeric Rating Scale.
Pain Intensity with Visual Analogue Scale
Time frame: During study visit, cross-sectional, once.
Pain Intensity will be measured with a Visual Analogue Scale.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2021.
- Derived from this study: PubMed 36722463Moens M, Billet B, Molenberghs G, De Smedt A, Pilitsis JG, De Vos R, Hanssens K, Billot M, Roulaud M, Rigoard P, Goudman L. Heart rate variability is not suitable as a surrogate marker for pain intensity in patients with chronic pain. Pain. 2023 Aug 1;164(8):1741-1749. doi: 10.1097/j.pain.0000000000002868. Epub 2023 Jan 19.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain, run by Moens Maarten at 2 sites in Belgium.
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 4 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: status not confirmed, as of the sponsor's last update on 25 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maarten Moens, prof. dr. (+32 2 477 55 14, maarten.moens@uzbrussel.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart Rate Variability (time frame: During study visit, cross-sectional, once, during 5 minutes.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04539353, which also lists 1 linked publication.
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 25 Feb 2021; AzTrials last refreshed its copy on 2 Nov 2026.