HRV and Pain Intensity

Chronic Pain Clinical Trial

Official title:

The Association Between Pain Intensity and Heart Rate Variability in Chronic Pain Patients.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04539353
• Other study ID #: INTERVAL
• Status: Recruiting
• Start date: December 14, 2020
• Est. completion date: October 15, 2021

Study information

• Verified date: February 2021
• Source: Universitair Ziekenhuis Brussel
• Contact: Maarten Moens, prof. dr.
• Phone: +32 2 477 55 14
• Email: maarten.moens[@]uzbrussel.be
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of this study is to explore the association between pain intensity and heart rate variability in patients with chronic pain.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: October 15, 2021
• Est. primary completion date: October 15, 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Chronic Pain
• Pain

Intervention

Other:
• Heart Rate Variability
Heart Rate Variability will be measured with a Polar device.
• Pain intensity
Pain Intensity will be measured with a Numeric Rating Scale and Visual Analogue Scale

Locations

Country	Name	City	State
Belgium	Universitair Ziekenhuis Brussel	Jette
Belgium	AZ Delta	Roeselare

Sponsors (1)

Lead Sponsor	Collaborator
Moens Maarten

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	Pain Intensity with Numeric Rating Scale	Pain Intensity will be measured with a Numeric Rating Scale.	During study visit, cross-sectional, once.
Primary	Pain Intensity with Visual Analogue Scale	Pain Intensity will be measured with a Visual Analogue Scale.	During study visit, cross-sectional, once.