Developing an Objective Measure of Experienced Pain

Pain, Acute Clinical Trial

Official title:

Developing an Objective Measure of Experienced Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05415423
• Other study ID #: 2022-00236
• Status: Completed
• Phase: N/A
• Start date: June 6, 2022
• Est. completion date: September 26, 2022

Study information

• Verified date: October 2022
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 330
• Est. completion date: September 26, 2022
• Est. primary completion date: September 26, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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).

Related Conditions & MeSH terms

• Acute Pain
• Pain, Acute

Intervention

Behavioral:
• Developing an objective measure of experienced pain
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.

Locations

Country	Name	City	State
Switzerland	SNS Laboratory	Zürich	CH

Sponsors (2)

Lead Sponsor	Collaborator
University of Zurich	Balgrist University Hospital

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Choices between monetary amounts and painful stimuli	Participants' choices between monetary amounts and painful stimuli	baseline
Primary	self-reported pain ratings according to Numerical Rating Scale (NRS)	self-reported pain ratings according to Numerical Rating Scale	baseline
Primary	self-reported pain ratings according to Visual Analogue Scale (VAS)	self-reported pain ratings according to Visual Analogue Scale	baseline
Primary	self-reported pain ratings according to general Labeled Magnitude Scale (gLMS)	self-reported pain ratings according to general Labeled Magnitude Scale	baseline
Primary	response times	Response times relative to participants' choices between monetary amounts and painful stimuli	baseline
Secondary	heart rate variability	variation in heat-beat rate in reaction to the painful stimuli.	baseline
Secondary	skin conductance	variation in skin conductance in reaction to the painful stimuli.	baseline
Secondary	pupil dilation	variation in pupil dilation in reaction to the painful stimuli.	baseline