- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07234123
Cognitive Conditioned Pain Modulation (CognitiveCPM)
Conditioned Pain Modulation With Ultra-Brief Conditioning Stimulus
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Conditioned pain modulation (CPM) is a natural process where feeling pain in one part of the body (e.g., a conditioning stimulus to the wrist) can reduce pain felt in another part of the body (a test stimulus to the foot). There is considerable evidence from both animal and human studies that the painful conditioning stimulus can stimulate the brain to activate neurochemical pain-control pathways (e.g., endogenous opioids), which are believed to take 30-120 seconds to fully engage. The current CPM study measures whether attentional processes can also make a measurable contribution to pain inhibition alongside neurochemical mechanisms.
Primary measures: Graphic ratings scale "worst pain" ratings.
The primary measure of the current study graphic ratings scales (worst pain ratings) will measure how much pain participants feel on their foot during foot only (test stimulus), vs. how much pain participants feel on their foot (test stimulus during simultaneous foot (test stimulus) + wrist (conditioning stimulus).
The current investigators predict that pain (e.g., the conditioning stimulus) naturally demands attention and can pull attention away from the original pain source (the test stimulus), resulting in CPM-like reductions in pain of the test stimulus.
Secondary measure #1. Cognitive measures are introduced in the current study, to quantify how much (if at all) the conditioning stimulus reduces pain of the target stimulus via attentional mechanisms. Participants estimate what percentage of their attention was directed to their foot (the test stimulus) during foot only vs. during foot + wrist (test + conditioning stimulus). This will measure whether the conditiioning stimulus to the wrist reduces how much attention participants focus on their foot. Analyses will also measure whether the amount of attention shift away from the foot (via participants; subjective ratings) is correlated with CPM robustness (reduction in pain of foot during duel stimulation).
Secondary measure #2. As another secondary measure of attention during one vs. two simultaneous pain stimuli, this study involves a divided attention auditory listening task that becomes harder when pain demands more attention (Craik et al., odd number divided attention task during single test pain stimuli vs. simultaneous test + conditioning stimuli). The more errors the participant makes on the divided attention task, the more attention diverted away from the auditory task by pain. Analyses will measure whether the number of errors on the divided attention task is correlated with CPM robustness (reduction in pain of foot, during duel thermal stimulation).
Exploratory measures. As exploratory measures, participants will rate how distracted they were and how difficult it was to concentrate (on 0-10 rating scales during test stimulus alone verses test + conditioning noxious thermal heat stimuli).
In summary, embedding these cognitive measures into the CPM protocol may enhance mechanistic interpretation accuracy by quantifying attentional contributions to pain inhibition in specific CPM protocols, thereby complementing existing approaches to pain phenotyping and reducing unexplained variance in CPM outcomes.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Washington
-
Seattle, Washington, United States, 98195
- University of Washington Seattle
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion criteria:
- Only University of Washington students in eligible psychological courses are
- eligible. General public is not eligible.
- Enrolled psychology students fluent in English,
- Age ≥18 y, able to follow instructions.
Exclusion criteria:
- Seizure history,
- Migraines,
- Diabetes,
- Extreme pain insensitivity,
- Motion sickness,
- or prior participation in this protocol.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Single pain stimulus
test pain stimulus alone
|
single brief stimulus to foot only
|
|
Experimental: dual pain stimuli
simultaneous foot (test stimulus + wrist (conditioning stimulus)
|
simultaneous stimuli to foot (test stimulus) and wrist (conditioning stimulus)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
worst pain ratings of foot only
Time Frame: rated immediately after each thermal stimulus
|
graphic rating scale from 0 (no pain) to 10 (excruciating pain)
|
rated immediately after each thermal stimulus
|
|
worst pain on graphic rating scale during test+conditioning stimulus
Time Frame: measured immediately after the stimuli
|
graphic rating scale from 0 (no pain) to 10 (excruciating pain)
|
measured immediately after the stimuli
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
% of attention devoted to foot during test stimulus only (0-100% scale)
Time Frame: rated immediately after the stimuli
|
verbal ratings where higher numbers = more attention
|
rated immediately after the stimuli
|
|
% of attention devoted to foot during test+conditioning stimuli (0-100% scale)
Time Frame: rated immediately after the thermal stimuli
|
verbal ratings where higher numbers = more attention
|
rated immediately after the thermal stimuli
|
|
Divided attention during test stimulus only (% correct, where 100% is highest accuracy)
Time Frame: Day 1, during the thermal stimulus
|
Accuracy monitoring a string of auditory numbers, the odd number task during test stimulus
|
Day 1, during the thermal stimulus
|
|
Divided attention during test stimulus + conditioning stimulus (% correct, 100% is highest )
Time Frame: Day 1, during the thermal stimuli
|
Accuracy monitoring a string of auditory numbers, the odd number task during dual stimuli
|
Day 1, during the thermal stimuli
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
distraction difficulty during test stimulus only (0 to 10 scale, where 10 is most distracting)
Time Frame: immediately after the phase 1 thermal stimuli
|
Exploratory: Distraction during the single test stimulus (graphic rating scales)
|
immediately after the phase 1 thermal stimuli
|
|
distraction difficult during simultaneous test + conditioning stimuli (graphic rating scale)
Time Frame: Exploratory: immediately after the phase 1 thermal stimuli
|
Exploratory: 0-10 distraction during simultaneous test + conditioning stimulus (10 =highest distraction)
|
Exploratory: immediately after the phase 1 thermal stimuli
|
|
difficulty concentrating during test stimulus only (0 to 10 scale, 10 = most difficult concentr
Time Frame: Exploratory: immediately after the phase 1 thermal stimuli
|
Exploratory: difficulty concentrating during the single test stimulus (graphic scales)
|
Exploratory: immediately after the phase 1 thermal stimuli
|
|
difficulty concentrating during simultaneous test + conditioning stimuli (graphic rating scale)
Time Frame: Exploratory: immediately after the phase 1 thermal stimuli
|
Exploratory: difficulty concentrating during simultaneous test + conditioning stimulus, 10 = most difficult
|
Exploratory: immediately after the phase 1 thermal stimuli
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Hunter Hoffman, University of Washington
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CPM2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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