PainNCT03280238
Pupil Dilation and Analgesia Nociception Index
A study testing Measurement of pupil dilation and analgesia nociception index in people with Pain, run by Vrije Universiteit Brussel at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Measurement of pupil dilation and analgesia nociception index
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Mar 2017to 31 May 2017
- Phase
- Interventional
- 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 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- good health
- no acute or chronic pain conditions
- well rested
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Do Pupil Dilation and Analgesia Nociception Index Reflect Pain: a Pilot Study in Healthy, Conscious Volunteers
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.
- Conditions
- Pain
- Being tested
- Measurement of pupil dilation and analgesia nociception index
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Diagnostic Test: Measurement of pupil dilation and analgesia nociception index |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pupil dilation in relation to pain
measurement of pupil dilation
Measured: 2sec before until 4sec after each painful stimulus
Secondary outcomes (1)
Analgesia nociception index in relation to pain
measurement of analgesia nociception index
Measured: 30sec before until 60sec after each painful stimulus
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2017
- Study start1 Mar 2017
- Primary completion31 May 2017
- Study completion31 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vrije Universiteit Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wendy Van Bogaert, Vrije Universiteit Brussel
- Investigators
- Wendy Van Bogaert, MS, Principal investigator, Vrije Universiteit BrusselReginald Deschepper, PhD, Study chair, Vrije Universiteit Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03280238
- Sponsor's protocol ID
- 2016/278
- Status last verified
- Sep 2017
- First submitted
- 5 Sep 2017
- Last updated
- 13 Sep 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 8737210Chapman 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.
PubMed 10098379Koenig 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.
PubMed 23922336
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Pupil Dilation and Analgesia Nociception Index Reflect Pain: a Pilot Study in Healthy, Conscious Volunteers
- ClinicalTrials.gov ID
- NCT03280238
- Acronym / sponsor ID
- 2016/278
- Conditions
- Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Vrije Universiteit BrusselUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 31 May 2017 (actual)
- Study completion
- 31 May 2017 (actual)
- First posted
- 12 Sep 2017 (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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experiment | Experimental | Diagnostic Test: Measurement of pupil dilation and analgesia nociception index* 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) |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- good health
- no acute or chronic pain conditions
- well rested
Key exclusion criteria (6 listed)
- chronic treatment
- bad health
- daily use of analgetics or other medication
- weekly tobacco use
- weekly use of recreational drugs
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 |
|---|---|---|
| Measurement of pupil dilation and analgesia nociception indexpainful electrical stimuli of various intensities were administered to the subjects after which changes in pupil diameter and analgesia nociception index were measured | Diagnostic test | Experiment |
Primary outcome
Pupil dilation in relation to pain
Time frame: 2sec before until 4sec after each painful stimulus
measurement of pupil dilation
1 secondary outcome
Analgesia nociception index in relation to pain
Time frame: 30sec before until 60sec after each painful stimulus
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2017.
- Background: PubMed 8737210Heart 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.
- Background: PubMed 10098379Chapman 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.
- Background: PubMed 23922336Koenig 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.
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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.
Wendy Van Bogaert, MS principal investigator
Vrije Universiteit Brussel
Reginald Deschepper, PhD study chair
Vrije Universiteit Brussel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Measurement of pupil dilation and analgesia nociception index in people with Pain, run by Vrije Universiteit Brussel at 1 site 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 3 inclusion and 6 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: finished, as of the sponsor's last update on 13 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pupil dilation in relation to pain (time frame: 2sec before until 4sec after each painful stimulus). 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 NCT03280238, which also lists 3 linked publications.
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 13 Sep 2017.