Atrium Health Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157, United States
NCT Number: NCT06651476
This study aims to answer the question: Does oxytocin increase the pain threshold on thermal heat pain in the presence of vibration on an area of skin exposed to a mild sunburn?
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Notify Me18 year–55 year
All sexes
Interventional
Phase 2
Winston-Salem, North Carolina, 27157, United States
The goal of this clinical trial is to test whether intravenous oxytocin increases the analgesic effect of vibration on heat pain threshold of skin that has been exposed to Ultraviolet-B (UV-B) burn (mild sunburn). Researchers will compare oxytocin (a hormone that naturally occurs in the body) to a placebo (a look-alike substance that contains no drug) to see if oxytocin works to increase the pain threshold (the lowest intensity at which one begins to perceive or sense a stimulus as being painful).
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Oxytocin 10 IU will be administered over 30 minutes by intravenous infusion and repeated 30 minutes after the end of the first infusion.
A placebo will be administered over 30 minutes by intravenous infusion and repeated 30 minutes after the end of the first infusion.
Time frame: 24 hours after UV-B exposure
Difference between heat pain threshold at 24 hours after Ultraviolet-B (UV-B) exposure at 3x minimum erythematous dose. The difference between the average threshold for stimuli #5-8 and the average threshold for stimuli #13-17 at baseline and 2 hours after the beginning of the oxytocin or placebo infusion will be used. The values are measured in degrees Celsius. A lower temperature indicates more sensitivity to heat pain.
Time frame: Two days after UV-B exposure
Difference between heat pain threshold at 24 hours after UV-B exposure at 3x minimum erythematous dose. The difference between the average threshold for stimuli #5-8 and the average threshold for stimuli #13-17 at baseline and 2 days after the beginning of the oxytocin or placebo infusion will be used. The values are measured in degrees Celsius. A lower temperature indicates more sensitivity to heat pain.
Time frame: 24 hours after UV-B exposure
Using an electronic von Frey instrument, threshold for touch and a prickly pain sensation will be determined at the site of UV-B exposure at 3x minimum erythematous dose and in normal skin to estimate the threshold for touch and prickly pain sensation. The measure will be recorded in grams. A lower pressure indicates more sensitivity to touch and pain.
Time frame: Two days after UV-B exposure
Using an electronic von Frey instrument, threshold for touch and a prickly pain sensation will be determined at the site of UV-B exposure at 3x minimum erythematous dose and in normal skin to estimate the threshold for touch and prickly pain sensation. The measure will be recorded in grams. A lower pressure indicates more sensitivity to touch and pain.
Wake Forest University Health Sciences
Other
A Randomized Controlled Trial to Test Whether Oxytocin Amplifies the Effect of Vibration to Increase Heat Pain Threshold After UV-B Burn
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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