Changes in Affective Pain Processing in Human Volunteers

NCT04280796 | Completed DMC

• 1 other identifier: PR00P1_179697/1
• Study Type: interventional
• Target: 183
• Locations: 1 country
• Sites: 1

Brief Summary

The experience of pain is more than the conscious perception of nociceptive signals. Emotional and motivational aspects accompany pain, leading to its aversiveness and motivation for avoidance. In chronic pain, a negative hedonic shift has been proposed that is characterized by disproportionally increased emotional-motivational compared to sensory-discriminative pain responses. Such a negative hedonic shift is, for example, mirrored in very high comorbidity rates of chronic pain and affective disorders such as depression and anxiety. The aim of this study is to develop methods that allow the differentiation of sensory-discriminative and emotional-motivational pain response and to characterize mechanisms of the negative hedonic shift.

Conditions

Pain, Acute; Pain, Chronic; Low Back Pain

Keywords

acute pain; chronic pain; low back pain; hedonic shift; emotional-motivation components of pain; sensory-discriminative components of pain; operant conditioning; metacognition

Outcome Measures

Primary Outcomes (1)

• ratio of sensory to emotional pain responses

  Ratio of the number of correct responses (%) in a task assessing sensory-discriminative pain responses to number of correct responses (%) in a task assessing emotional-motivational pain responses.

  during the procedure

Secondary Outcomes (11)

• reaction time (RT)

  during the procedure

• pain threshold

  baseline

• pain tolerance

  baseline

• perceived pain intensity

  during the procedure

• perceived pain unpleasantness

  during the procedure

Study Arms (3)

Substudy 1

EXPERIMENTAL

All participants will perform two psychophysical tasks to assess sensory-discriminative and emotional-motivational pain responses independently from each other. No arms will perform. In addition, in Substudy 1 an operant learning paradigm will be implemented to dissociate these responses, increasing the sensory-discriminative pain responses compared to emotional-motivational pain responses by contingent monetary reinforcement and vice versa. Primary objectives: 1. To develop psychophysical methods that allow the independent assessment of sensory-discriminative and emotional-motivational pain responses and 2. to show that emotional-motivational and sensory-discriminative pain components can be dissociated Secondary objective: To assess whether fear of pain, fear-avoidance beliefs, pain catastrophizing, and sensation seeking as personality traits can explain variations in how strongly sensory-discriminative and emotional-motivational pain responses can be dissociated

Behavioral: psychophysical tasks

Substudy 2

EXPERIMENTAL

All participants will perform two psychophysical tasks to assess sensory-discriminative and emotional-motivational pain responses independently from each other. No arms will perform. In addition, in Substudy 2, responses of chronic pain patients will be compared to those of healthy participants to characterize possible alterations in the patients and operant learning will be operationalized to decrease emotional-motivational pain responses, which are assumed to be already increased in the patients. Primary objective: To demonstrate that in chronic pain patients, emotional-motivational pain responses are increased relative to sensory-discriminative pain responses Secondary objective: To assess whether fear of pain, fear-avoidance beliefs, pain catastrophizing, and sensation seeking as personality traits can explain variations in the present dissociation of sensory-discriminative and emotional-motivational pain responses in chronic pain patients

Behavioral: psychophysical tasks

Substudy 3

EXPERIMENTAL

All participants will perform a psychophysical task to assess metacognition in pain perception as an indicator of the cognitive-evaluative pain component. No arms will perform. Primary objective: To assess whether metacognition on pain perception are involved and subjective ratings of perceived pain and how metacognition relates to pain intensity. Secondary objective: To assess whether confidentiality as a personality trait , pain catastrophizing, and skin conductance responses are related to metacognition in pain.

Behavioral: cognitive task

Interventions

psychophysical tasks BEHAVIORAL

All participants perform two psychophysical tasks to assess sensory-discriminative and emotional-motivational pain responses independently from each other. In addition, in Substudy 1 an operant learning paradigm will be implement to dissociate these responses, increasing the sensory-discriminative pain responses compared to emotional-motivational pain responses by contingent monetary reinforcement or vice versa. In Substudy 2, responses of chronic pain patients will be compared to those of healthy participants to characterize possible alterations and operant learning will be operationalized to decrease emotional-motivational pain responses, which are assumed to be already increased in the patients.

Substudy 1; Substudy 2

cognitive task BEHAVIORAL

In Substudy 3 participants will perform a psychophysical task to assess metacognition in pain perception as an indicator of the cognitive-evaluative pain component.

Substudy 3

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• good overall health status
• sufficient knowledge of German or English to follow instructions
• ability to give written informed consent

You may not qualify if:

• pain longer than \>3 consecutive days and on more than 30 days within the last 12 months
• major psychiatric or neurological disorders, and substance abuse
• consumption of alcohol, illegal drugs, and analgesic drug within 24 hours before testing
• For chronic pain patients
• unspecific musculoskeletal chronic pain
• sufficient knowledge of German or English to follow instructions
• ability to give written informed consent
• major psychiatric or neurological disorders, excluding depression and anxiety, and substance abuse
• consumption of alcohol, illegal drugs, and analgesic drugs within 24 hours before testing

Sponsors & Collaborators

• susanne becker: lead
• SNSF: collaborator

Study Sites (1)

Balgrist Campus

Zurich, 8008, Switzerland

Location

MeSH Terms

Conditions

Acute Pain; Chronic Pain; Low Back Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Back Pain

Study Officials

• Susanne Becker, PD Dr.

  Balgrist Universitätsklinik

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: participants are not fully instructed about the purpose before and during the test but will be debriefed after testing
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Research Group

Model Details: Study comprises an intervention that is neither a therapeutic or transplant product nor a transplant. Study involves minimal risks for participants. Used methods are within the range of standard methods frequently used in pain research. All participants will perform 2 psychophysical tasks to assess sensory-discriminative \& emotional-motivational pain responses independently from each other. Substudy1: An operant learning paradigm will be implemented to dissociate these responses, increasing the sensory-discriminative compared to emotional-motivational pain responses by contingent monetary reinforcement \& vice versa. Substudy2: Responses of chronic pain patients will be compared to those of healthy participants to characterize possible alterations. Operant learning will be operationalized to decrease emotional-motivational pain responses, which are assumed to be increased in patients. Substudy3: Participants will perform a psychophysical task to assess metacognition in pain perception.

Study Record Dates

• First Submitted: January 15, 2020
• First Posted: February 21, 2020
• Study Start: September 21, 2020
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2023
• Last Updated: November 21, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)