CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 60 enrolled
Drug / intervention
Conditioned Pain Modulation (CPM)behavioral
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05783362
NCT05783362N/ACompleted

Pain Modulation Effectiveness: An Experimental Study Using Repeated Conditioned Pain Modulation as an Intervention and Analyzing Potential Predictors in Healthy Adults.

University of Florida·interventional·Posted Mar 24, 2023·Updated Aug 31, 2023

In Brief

A clinical study evaluating Conditioned Pain Modulation (CPM) for Healthy People. Completed, enrolled 60 participants across 1 site.

Detailed Summary

Conditioned pain modulation (CPM) is the behavioral measure of diffuse noxious inhibitory control (DNIC), an endogenous pain inhibitory pathway in which pain inhibits pain. Conditioned pain modulation is less efficient in individuals with chronic pain conditions, and it is a predictor for the development of chronic pain. Continuous stimulation of central/cortical mechanisms through engaging CPM might alter pain processing and improve pain inhibition. Healthy participants will be randomly assigned to one of three groups: High Exposure (HE), Low Exposure (LE), and No Exposure (NE). Pre-and post-intervention pain sensitivity including conditioned pain modulation will be assessed. The study will assess the central pain modulatory mechanisms (measured by CPM) that have differential changes in participants who receive high exposure CPM as an intervention from those who receive low or no exposure. The study will also assess the magnitude and efficiency of CPM contributing additional variance to a regression model predicting pain sensitivity after positive and negative affect, pain anxiety, and depression are considered in the model, establishing measures of central pain processing, like CPM, as unique contributors to pain intensity.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy People
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
202420252026
First PostedMar 24, 2023
Enrollment StartApr 1, 2023
Primary CompletionJun 25, 2023
Study CompletionAug 25, 2023
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 3.3 years ago

Interventions

Conditioned Pain Modulation (CPM)behavioral

Participants will receive a testing stimulus of pressure applied per ascending intensity at the web space of the foot until the pain reaches 40 out of 100, then discontinued. After testing the stimulus, participants will then receive a conditioning stimulus by immersing the non-dominant hand into the water-cooled by refrigeration unit with a temperature of 6 degree Celsius (males) or 8 degree Celsius (females) for 60 seconds. Subjects will be asked to rate the cold pain during the four 60-second trials. Participants completely removed their hand from the cold pressor for 30 seconds following each of the four 60-second immersions, during which time the testing stimulus will be re-applied per the sequential paradigm to the web space of the foot. Participants complete four 60-second periods of immersion. Conditioned pain modulation will be calculated as the average pain ratings of the second testing stimulus series minus the average pain ratings of the first testing stimulus series.