NCT03280238

Brief Summary

Pain assessment is crucial in clinical practice. Currently, subjective self-report is considered the most appropriate method to evaluate pain. Although several methods to assess pain objectively exist, the lack of a golden standard still remains. This pilot study assesses the changes in pupil dilation (PD) and the analgesia nociception index (ANI) as a measure of pain in healthy, conscious, male volunteers in a highly standardized and individualized environment. Nineteen subjects received three blocks of 4 individualized electrical stimulus intensities, ranging from no to severe pain. Subjects reported their perceived severity of each individual stimulus, enabling the comparison of changes in PD and ANI in relation to both administered stimulus intensities and perceived pain severities. PD and ANI were measured before and after each administration of a stimulus.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable pain

Timeline
Completed

Started Mar 2017

Shorter than P25 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

March 1, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 5, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 12, 2017

Completed
Last Updated

September 13, 2017

Status Verified

September 1, 2017

Enrollment Period

3 months

First QC Date

September 5, 2017

Last Update Submit

September 12, 2017

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

  • Pupil dilation in relation to pain

    measurement of pupil dilation

    2sec before until 4sec after each painful stimulus

Secondary Outcomes (1)

  • Analgesia nociception index in relation to pain

    30sec before until 60sec after each painful stimulus

Study Arms (1)

Experiment

EXPERIMENTAL

* Individualized painful electrical stimuli, Surpass LT stimulator (EMS Biomedical, Korneuburg, Austria) with a bipolar felt pad electrode * Measurement of pupil diameter, Algiscan® (iDMed, Marseille, France) * Measurement of Analgesia Nociception Index, PhysioDoloris® (MetroDoloris, Lille, France)

Diagnostic Test: Measurement of pupil dilation and analgesia nociception index

Interventions

Measurement of pupil dilation and analgesia nociception indexDIAGNOSTIC_TEST

painful electrical stimuli of various intensities were administered to the subjects after which changes in pupil diameter and analgesia nociception index were measured

Experiment

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • good health
  • no acute or chronic pain conditions
  • well rested

You may not qualify if:

  • chronic treatment
  • bad health
  • daily use of analgetics or other medication
  • weekly tobacco use
  • weekly use of recreational drugs
  • more than 10 alcohol consumptions a week

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ Brussel

Jette, 1090, Belgium

Location

Related Publications (3)

  • Heart rate variability. Standards of measurement, physiological interpretation, and clinical use. Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology. Eur Heart J. 1996 Mar;17(3):354-81. No abstract available.

    PMID: 8737210BACKGROUND

  • Chapman CR, Oka S, Bradshaw DH, Jacobson RC, Donaldson GW. Phasic pupil dilation response to noxious stimulation in normal volunteers: relationship to brain evoked potentials and pain report. Psychophysiology. 1999 Jan;36(1):44-52. doi: 10.1017/s0048577299970373.

    PMID: 10098379BACKGROUND

  • Koenig J, Jarczok MN, Ellis RJ, Hillecke TK, Thayer JF. Heart rate variability and experimentally induced pain in healthy adults: a systematic review. Eur J Pain. 2014 Mar;18(3):301-14. doi: 10.1002/j.1532-2149.2013.00379.x. Epub 2013 Aug 6.

    PMID: 23922336BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Wendy Van Bogaert, MS

    Vrije Universiteit Brussel

    PRINCIPAL INVESTIGATOR

  • Reginald Deschepper, PhD

    Vrije Universiteit Brussel

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Student

Study Record Dates

First Submitted

September 5, 2017

First Posted

September 12, 2017

Study Start

March 1, 2017

Primary Completion

May 31, 2017

Study Completion

May 31, 2017

Last Updated

September 13, 2017

Record last verified: 2017-09

Locations

BE(1)