Developing an Objective Measure of Experienced Pain

NCT ID: NCT05415423

Last Updated: 2022-10-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 330 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-06
• Study Completion Date: 2022-09-26

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.

Conditions

Pain, Acute

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Study 1 Low-Intensity Group

Control group which receives less intense electrical stimuli than the other.

Group Type: ACTIVE_COMPARATOR

Developing an objective measure of experienced pain

Intervention Type: BEHAVIORAL

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 1 High-Intensity Group

Group which receives more intense electrical stimuli than the other.

Group Type: EXPERIMENTAL

Developing an objective measure of experienced pain

Intervention Type: BEHAVIORAL

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 2 Low-Intensity Group

Control group which receives less intense heat stimuli than the other.

Group Type: ACTIVE_COMPARATOR

Developing an objective measure of experienced pain

Intervention Type: BEHAVIORAL

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 2 High-Intensity Group

Group which receives more intense heat stimuli than the other.

Group Type: EXPERIMENTAL

Developing an objective measure of experienced pain

Intervention Type: BEHAVIORAL

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 3 Placebo group

A group that receives a placebo cream.

Group Type: PLACEBO_COMPARATOR

Developing an objective measure of experienced pain

Intervention Type: BEHAVIORAL

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 3 Painkiller group

A group that receives a topical analgesic such as EMLA cream.

Group Type: EXPERIMENTAL

Developing an objective measure of experienced pain

Intervention Type: BEHAVIORAL

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 4 test-retest reliability group

Participants who participated in either Study 1 or 2 are recruited. They will experience both electrical and heat stimuli.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Balgrist University Hospital

OTHER

Sponsor Role: collaborator

University of Zurich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

SNS Laboratory

Zurich, CH, Switzerland

Countries

Switzerland

Other Identifiers

2022-00236

Identifier Type: -

Identifier Source: org_study_id