Pain, AcuteNCT05415423
Developing an Objective Measure of Experienced Pain
A study testing Developing an objective measure of experienced pain in people with Pain, Acute, run by University of Zurich at 1 site in Switzerland.
Trial summary
Pain is a public health challenge around the world. However, there is no single standardized measure of pain, to the point that the estimated prevalence of chronic pain in adults ranges between 2% and 64% depending on the methods and definitions used. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Acute
- What is being tested?
- Developing an objective measure of experienced pain
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 330 participants
- Where
- 1 siteSwitzerland
- Study dates
- 6 Jun 2022to 26 Sep 2022
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- age 18-60 years.
- ability and willingness to participate in the study
- declaration of consent
- good English language skills (to ensure understanding of all instructions and the declaration of consent).
Who cannot join
- inability to give the declaration of consent (e.g. due to linguistic difficulties understanding the study information)
- any neurological disorders
- reduced general health / chronic diseases (e.g. autoimmune disease, severe cardiovascular diseases, insulin-dependent diabetes, severe depression); chronic pain disorders
- pregnancy
- in the week before the experimental session self-reported intake of drugs which could influence pain perception (e.g. cannabis and ADHD medications).
Trial locations and contacts
1 site in 1 country.
About this study
Pain is a public health challenge around the world. However, there is no single standardized measure of pain, to the point that the estimated prevalence of chronic pain in adults ranges between 2% and 64% depending on the methods and definitions used. Existing measures of pain are known to present several problems and results can be hardly compared between people.
The investigators propose and empirically validate a new, simple method to measure experienced pain in clinical trials. The method provides an objective, cardinal measurement of experienced pain which is comparable between people and the investigators test whether it is better able to measure experienced pain than existing procedures. The investigators test the new method in healthy participants using standard protocols (electrical and heat stimuli). The investigators also aim to validate the measure using a causal manipulation which relies on the administration of a topical analgesic product compared to a placebo.
Read the detailed description
The aim of this study is to establish and validate the proposed method of measuring pain using different pain stimuli. The investigators correlate these measurements with physiological data such as skin-conductance, heart-rate variability, pupil dilation, and with established measures of pain such as Numeric rating scale (NRS), Visual analog scale (VAS), general Labeled Magnitude Scale (gLMS). In addition, the investigators study the test-retest reliability of our measure of pain and its ability to capture a reduction in experienced pain due to a topical analgesic product compared to a placebo treatment.
- Conditions
- Pain, Acute
- Being tested
- Developing an objective measure of experienced pain
- Keywords
- Measurement of Pain, Pain
- Medical subject headings
- Acute Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Developing an objective measure of experienced painBehavioural
At the beginning of each study, participants are randomly allocated into one of two groups.
Within each group all participants are exposed to the same painful stimulus. One group experiences a painful stimulus of higher intensity compared to that of the other group. The painful stimuli are physically identical for every subject within the same group and within the standard of previous pain research.
Participants are then asked to evaluate the painful stimulus they just received according to a self-reported scale (NRS, VAS, gLMS, NRS-MB). Participants are also asked to decide multiple times whether they prefer a larger amount of money and experience the same or more painful stimulus they received before or a smaller amount of money and no (or a less) painful stimulus. The smaller amount of money is progressively increased across choices until it matches the larger amount, similar to multiple price-list methods (MPL) which are standard in economics.
| Study group | Role | What they receive |
|---|---|---|
| Study 1 Low-Intensity Group | Active comparator | Control group which receives less intense electrical stimuli than the other. Receives: Behavioral: Developing an objective measure of experienced pain |
| Study 1 High-Intensity Group | Experimental | Group which receives more intense electrical stimuli than the other. Receives: Behavioral: Developing an objective measure of experienced pain |
| Study 2 Low-Intensity Group | Active comparator | Control group which receives less intense heat stimuli than the other. Receives: Behavioral: Developing an objective measure of experienced pain |
| Study 2 High-Intensity Group | Experimental | Group which receives more intense heat stimuli than the other. Receives: Behavioral: Developing an objective measure of experienced pain |
| Study 3 Placebo group | Placebo comparator | A group that receives a placebo cream. Receives: Behavioral: Developing an objective measure of experienced pain |
| Study 3 Painkiller group | Experimental | A group that receives a topical analgesic such as EMLA cream. Receives: Behavioral: Developing an objective measure of experienced pain |
| Study 4 test-retest reliability group | No intervention | Participants who participated in either Study 1 or 2 are recruited. They will experience both electrical and heat stimuli. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Choices between monetary amounts and painful stimuli
Participants' choices between monetary amounts and painful stimuli
Measured: baseline
self-reported pain ratings according to Numerical Rating Scale (NRS)
self-reported pain ratings according to Numerical Rating Scale
Measured: baseline
self-reported pain ratings according to Visual Analogue Scale (VAS)
self-reported pain ratings according to Visual Analogue Scale
Measured: baseline
self-reported pain ratings according to general Labeled Magnitude Scale (gLMS)
self-reported pain ratings according to general Labeled Magnitude Scale
Measured: baseline
response times
Response times relative to participants' choices between monetary amounts and painful stimuli
Measured: baseline
Secondary outcomes (3)
heart rate variability
variation in heat-beat rate in reaction to the painful stimuli.
Measured: baseline
skin conductance
variation in skin conductance in reaction to the painful stimuli.
Measured: baseline
pupil dilation
variation in pupil dilation in reaction to the painful stimuli.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2022
- Study start6 Jun 2022
- Primary completion26 Sep 2022
- Study completion26 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, AcuteStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Balgrist University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05415423
- Sponsor's protocol ID
- 2022-00236
- Status last verified
- Oct 2022
- First submitted
- 30 May 2022
- Last updated
- 12 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing an Objective Measure of Experienced Pain
- ClinicalTrials.gov ID
- NCT05415423
- Acronym / sponsor ID
- 2022-00236
- Conditions
- Pain, Acute
- Keywords
- Measurement of Pain, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- Balgrist University Hospital
- Study start
- 6 Jun 2022 (actual)
- Primary completion
- 26 Sep 2022 (actual)
- Study completion
- 26 Sep 2022 (actual)
- First posted
- 13 Jun 2022 (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 is a public health challenge around the world. However, there is no single standardized measure of pain, to the point that the estimated prevalence of chronic pain in adults ranges between 2% and 64% depending on the methods and definitions used. Existing measures of pain are known to present several problems and results can be hardly compared between people.
The investigators propose and empirically validate a new, simple method to measure experienced pain in clinical trials. The method provides an objective, cardinal measurement of experienced pain which is comparable between people and the investigators test whether it is better able to measure experienced pain than existing procedures. The investigators test the new method in healthy participants using standard protocols (electrical and heat stimuli). The investigators also aim to validate the measure using a causal manipulation which relies on the administration of a topical analgesic product compared to a placebo.
Detailed description
The aim of this study is to establish and validate the proposed method of measuring pain using different pain stimuli. The investigators correlate these measurements with physiological data such as skin-conductance, heart-rate variability, pupil dilation, and with established measures of pain such as Numeric rating scale (NRS), Visual analog scale (VAS), general Labeled Magnitude Scale (gLMS). In addition, the investigators study the test-retest reliability of our measure of pain and its ability to capture a reduction in experienced pain due to a topical analgesic product compared to a placebo treatment.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Study 1 Low-Intensity Group | Active comparator | Behavioral: Developing an objective measure of experienced painControl group which receives less intense electrical stimuli than the other. |
| Study 1 High-Intensity Group | Experimental | Behavioral: Developing an objective measure of experienced painGroup which receives more intense electrical stimuli than the other. |
| Study 2 Low-Intensity Group | Active comparator | Behavioral: Developing an objective measure of experienced painControl group which receives less intense heat stimuli than the other. |
| Study 2 High-Intensity Group | Experimental | Behavioral: Developing an objective measure of experienced painGroup which receives more intense heat stimuli than the other. |
| Study 3 Placebo group | Placebo comparator | Behavioral: Developing an objective measure of experienced painA group that receives a placebo cream. |
| Study 3 Painkiller group | Experimental | Behavioral: Developing an objective measure of experienced painA group that receives a topical analgesic such as EMLA cream. |
| Study 4 test-retest reliability group | No intervention | –Participants who participated in either Study 1 or 2 are recruited. They will experience both electrical and heat stimuli. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- age 18-60 years.
- ability and willingness to participate in the study
- declaration of consent
- good English language skills (to ensure understanding of all instructions and the declaration of consent).
Key exclusion criteria (5 listed)
- inability to give the declaration of consent (e.g. due to linguistic difficulties understanding the study information)
- any neurological disorders
- reduced general health / chronic diseases (e.g. autoimmune disease, severe cardiovascular diseases, insulin-dependent diabetes, severe depression); chronic pain disorders
- pregnancy
- in the week before the experimental session self-reported intake of drugs which could influence pain perception (e.g. cannabis and ADHD medications).
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 |
|---|---|---|
| Developing an objective measure of experienced painAt the beginning of each study, participants are randomly allocated into one of two groups. Within each group all participants are exposed to the same painful stimulus. One group experiences a painful stimulus of higher intensity compared to that of the other group. The painful stimuli are physically identical for every subject within the same group and within the standard of previous pain research. Participants are then asked to evaluate the painful stimulus they just received according to a self-reported scale (NRS, VAS, gLMS, NRS-MB). Participants are also asked to decide multiple times whether they prefer a larger amount of money and experience the same or more painful stimulus they received before or a smaller amount of money and no (or a less) painful stimulus. The smaller amount of money is progressively increased across choices until it matches the larger amount, similar to multiple price-list methods (MPL) which are standard in economics. | Behavioural | Study 1 High-Intensity Group, Study 1 Low-Intensity Group, Study 2 High-Intensity Group, Study 2 Low-Intensity Group, Study 3 Painkiller group, Study 3 Placebo group |
Primary outcome
Choices between monetary amounts and painful stimuli
Time frame: baseline
Participants' choices between monetary amounts and painful stimuli
self-reported pain ratings according to Numerical Rating Scale (NRS)
Time frame: baseline
self-reported pain ratings according to Numerical Rating Scale
self-reported pain ratings according to Visual Analogue Scale (VAS)
Time frame: baseline
self-reported pain ratings according to Visual Analogue Scale
self-reported pain ratings according to general Labeled Magnitude Scale (gLMS)
Time frame: baseline
self-reported pain ratings according to general Labeled Magnitude Scale
response times
Time frame: baseline
Response times relative to participants' choices between monetary amounts and painful stimuli
3 secondary outcomes
heart rate variability
Time frame: baseline
skin conductance
Time frame: baseline
pupil dilation
Time frame: baseline
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 12 Oct 2022.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Developing an objective measure of experienced pain in people with Pain, Acute, run by University of Zurich at 1 site in Switzerland.
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 4 inclusion and 5 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 12 Oct 2022. 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 Switzerland. 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. Some participants in this study may receive a placebo. 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?
Choices between monetary amounts and painful stimuli (time frame: baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Oct 2022.