Healthy People Clinical Trial
— PMEOfficial title:
Pain Modulation Effectiveness: An Experimental Study Using Repeated Conditioned Pain Modulation as an Intervention and Analyzing Potential Predictors in Healthy Adults.
Verified date | August 2023 |
Source | University of Florida |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | August 25, 2023 |
Est. primary completion date | June 25, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: 1. Not currently seeking treatment for pain past month; 2. between 18 - 75 years old. Exclusion Criteria: Participants will not be excluded based on race or gender but will be excluded if they meet any of the following 1. non-English speaking; 2. systemic medical condition is known to affect sensation (i.e., diabetes); 3. regular use of prescription pain medication to manage pain; 4. current or history of chronic pain condition; 5. currently using blood thinning medication; 6. any blood clotting disorder such as hemophilia; 7. any contraindication to the application of ice or cold packs, such as uncontrolled hypertension, cold urticaria, cryoglobulinemia, paroxysmal cold hemoglobinuria, and circulatory compromise; 8. involved in vigorous physical activities like heavy lifting, digging, aerobics or fast bicycling. |
Country | Name | City | State |
---|---|---|---|
United States | University of Florida | Gainesville | Florida |
Lead Sponsor | Collaborator |
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University of Florida |
United States,
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* Note: There are 15 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Conditioned Pain Modulation as an assessment | 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 receive a conditioning stimulus contact heat stimulus applied to the thenar of the left hand for 60 s at an intensity of 46.5 ?C. Subjects will be asked to rate the heat pain during the four 60-second trials. Subjects will be instructed that they may remove their hand at any time if the heat is intolerable. After 60 seconds, the contact heat will be completely removed, and the testing stimulus will be re-applied to the web space of the dominant foot. 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. Negative numbers indicate efficient pain modulation | Two weeks | |
Primary | Expectations | Individuals will be asked what they expect exposure to the coldpressor task to do the amount of pressure needed to generate pain (see "Intervention" for the coldpressor task). | Two Weeks |
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