HRV and Pain Intensity

NCT ID: NCT04539353

Last Updated: 2021-02-25

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

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-14

Study Completion Date

2021-10-15

Brief Summary

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

Detailed Description

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Conditions

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Chronic Pain

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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chronic pain

Patients with chronic pain, regardless of the cause of the pain.

Heart Rate Variability

Intervention Type OTHER

Heart Rate Variability will be measured with a Polar device.

Pain intensity

Intervention Type OTHER

Pain Intensity will be measured with a Numeric Rating Scale and Visual Analogue Scale

Interventions

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Heart Rate Variability

Heart Rate Variability will be measured with a Polar device.

Intervention Type OTHER

Pain intensity

Pain Intensity will be measured with a Numeric Rating Scale and Visual Analogue Scale

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Moens Maarten

OTHER

Sponsor Role lead

Responsible Party

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Moens Maarten

principal investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Universitair Ziekenhuis Brussel

Jette, , Belgium

Site Status RECRUITING

AZ Delta

Roeselare, , Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Maarten Moens, prof. dr.

Role: CONTACT

+32 2 477 55 14

Facility Contacts

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Maarten Moens, Prof. dr.

Role: primary

Bart Billet, dr.

Role: primary

References

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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.

Reference Type DERIVED
PMID: 36722463 (View on PubMed)

Other Identifiers

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INTERVAL

Identifier Type: -

Identifier Source: org_study_id

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