HRV and Pain Intensity
The Association Between Pain Intensity and Heart Rate Variability in Chronic Pain Patients.
1 other identifier
observational
200
1 country
2
Brief Summary
The aim of this study is to explore the association between pain intensity and heart rate variability in patients with chronic pain.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2020
Shorter than P25 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 26, 2020
CompletedFirst Posted
Study publicly available on registry
September 7, 2020
CompletedStudy Start
First participant enrolled
December 14, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 15, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 15, 2021
CompletedFebruary 25, 2021
February 1, 2021
10 months
August 26, 2020
February 24, 2021
Conditions
Outcome Measures
Primary Outcomes (3)
Heart Rate Variability
Heart Rate Variability will be measured with a Polar device during a 5 minute recording.
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.
During study visit, cross-sectional, once.
Pain Intensity with Visual Analogue Scale
Pain Intensity will be measured with a Visual Analogue Scale.
During study visit, cross-sectional, once.
Study Arms (1)
chronic pain
Patients with chronic pain, regardless of the cause of the pain.
Interventions
Pain Intensity will be measured with a Numeric Rating Scale and Visual Analogue Scale
Eligibility Criteria
Chronic pain patients (regardless of the cause of the pain).
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Moens Maartenlead
Study Sites (2)
Universitair Ziekenhuis Brussel
Jette, 1090, Belgium
AZ Delta
Roeselare, 8800, Belgium
Related Publications (1)
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.
PMID: 36722463DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- principal investigator
Study Record Dates
First Submitted
August 26, 2020
First Posted
September 7, 2020
Study Start
December 14, 2020
Primary Completion
October 15, 2021
Study Completion
October 15, 2021
Last Updated
February 25, 2021
Record last verified: 2021-02