Clinical trial NCT05415423: Developing an Objective Measure of Experienced Pain
Official title: Developing an Objective Measure of Experienced Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Acute
Keywords: Measurement of Pain
Pain
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: Balgrist University Hospital
First posted: 2022-06-13
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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).

Primary outcomes:
measure: Choices between monetary amounts and painful stimuli
timeFrame: baseline
measure: self-reported pain ratings according to Numerical Rating Scale (NRS)
timeFrame: baseline
measure: self-reported pain ratings according to Visual Analogue Scale (VAS)
timeFrame: baseline
measure: self-reported pain ratings according to general Labeled Magnitude Scale (gLMS)
timeFrame: baseline
measure: response times
timeFrame: baseline
Secondary outcomes:
measure: heart rate variability
timeFrame: baseline
measure: skin conductance
timeFrame: baseline
measure: pupil dilation
timeFrame: baseline
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: SNS Laboratory
state: CH
Study officials:
References: