About Bolder Science

Our mission is to provide healthcare professionals with unbiased clinical research information, easily.

Currently, you can access the following clinical trials being conducted worldwide:

359,057 studies
in
219 countries
Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/22/2021.
This website is for US healthcare professionals

Log In to Bolder Science

or

Don't have an account? Sign Up

Please enter your email address.

You will receive a link to create a new password via email.

Log In

Create an Account

or
(optional) ?

Welcome, !

Please complete the following 4 questions to ensure you receive the information that best suits your needs.

Clinical Trials of Interest

When I’m looking for information on clinical trials, I usually am interested in...

finding clinical trials in which to enroll my patients

Rarely Often

finding newly launched clinical trials (for all phases)

Rarely Often

updates on status changes for clinical trials

Rarely Often

pipeline molecules

Rarely Often

Drug Interventions

Enter up to 3 drug interventions you are currently interested in:

Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/22/2021.

Effects of Intramuscular Oxytocin on Sensory Function in Healthy Volunteers With Ultraviolet Burn Injury to the Skin

Clinicaltrials.gov identifier NCT03935399

Recruitment Status Completed

First Posted May 2, 2019

Last update posted August 21, 2020

Study Description

Brief summary:

This study proposes to evaluate the effects that a dose of oxytocin given by intramuscular (IM) injection (into the muscle) will have on an area of skin that has been exposed to ultraviolet (UV) light. The area of skin exposed to UV light will have a mild sun burn feeling. Sensory testing will be performed on the area of UV burn. The area will be evaluated for sensitivity in 3 methods: touch, vibratory

  • Condition or Disease:Chronic Pain
  • Intervention/Treatment: Drug: Oxytocin
    Other: Placebo
  • Phase: Phase 4
Detailed Description

This protocol aims to provide an estimate of effect size of intramuscular oxytocin on a test of Aβ and of Aδ fiber sensitivity in injured skin following ultraviolet B (UVB) burned skin. For the primary goal - to examine the effects of oxytocin peripheral nerves after tissue injury - the investigators chose the controlled ultraviolet sunburn model. The investigators propose a randomized, blinded, cross over design with treatment with oxytocin one day and placebo on another. Following baseline measures on each of the two study days, participants will receive an intramuscular injection of oxytocin (Pitocin®) in its indicated dose of 10 IU (17 μg) or an equivalent volume of saline. In order to determine the highest frequency that Aβ nerve fibers can respond to, the investigators will use a device that produces an oscillatory / vibratory stimulus which can be used on the hand. Pain threshold to punctate stimulation within the area of irradiation will be determined using calibrated von Frey filaments and an up-down sequential method which efficiently estimates median thresholds. Thermal heat testing will also be performed by the surface of the skin of the forearm or leg is heated to 45°C using a computer controlled thermode for a period of 5 minutes.

Study Design
  • Study Type: Interventional
  • Actual Enrollment: 10 participants
  • Allocation: Randomized
  • Intervention Model: Crossover Assignment
  • Intervention Model Description: Double blinded crossover treatment with oxytocin and placebo (saline)
  • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Primary Purpose: Basic Science
  • Official Title: Effects of Intramuscular Oxytocin on Sensory Function in Healthy Volunteers With Ultraviolet Burn Injury to the Skin
  • Actual Study Start Date: August 2019
  • Actual Primary Completion Date: March 2020
  • Actual Study Completion Date: April 2020
Arms and interventions
Arm Intervention/treatment
Active Comparator: Oxytocin
Intramuscular injection of oxytocin (Pitocin®), 10 IU
Drug: Oxytocin
oxytocin (Pitocin®), 10 IU
Placebo Comparator: Placebo
Intramuscular injection of (1 ml) of saline
Other: Placebo
Placebo (saline)
Outcome Measures
  • Primary Outcome Measures: 1. Vibration frequency detection threshold (when vibration is first felt) after IM Oxytocin injection [ Time Frame: 5 minutes ]
    Vibration frequency detection threshold in the burned area after IM Oxytocin injection will be obtained by the subject placing the forearm area that was exposed to the UV burn on the oscillatory device and informing the investigators when the first perception of vibration is felt. A recording of the frequency (1 kilo Hertz to 1 Hertz) will be documented.
  • 2. Vibration frequency detection threshold (when vibration is first felt) after IM Oxytocin injection [ Time Frame: 15 minutes ]
    Vibration frequency detection threshold in the burned area after IM Oxytocin injection will be obtained by the subject placing the forearm area that was exposed to the UV burn on the oscillatory device and informing the investigators when the first perception of vibration is felt. A recording of the frequency (1 kilo Hertz to 1 Hertz) will be documented.
  • 3. Vibration frequency detection threshold (when vibration is first felt) after IM Oxytocin injection [ Time Frame: 30 minutes ]
    Vibration frequency detection threshold in the burned area after IM Oxytocin injection will be obtained by the subject placing the forearm area that was exposed to the UV burn on the oscillatory device and informing the investigators when the first perception of vibration is felt. A recording of the frequency (1 kilo Hertz to 1 Hertz) will be documented.
  • 4. Vibration frequency detection threshold (when vibration is first felt) after IM Oxytocin injection [ Time Frame: 45 minutes ]
    Vibration frequency detection threshold in the burned area after IM Oxytocin injection will be obtained by the subject placing the forearm area that was exposed to the UV burn on the oscillatory device and informing the investigators when the first perception of vibration is felt. A recording of the frequency (1 kilo Hertz to 1 Hertz) will be documented.
  • 5. Vibration frequency detection threshold (when vibration is first felt) after IM Oxytocin injection [ Time Frame: 60 minutes ]
    Vibration frequency detection threshold in the burned area after IM Oxytocin injection will be obtained by the subject placing the forearm area that was exposed to the UV burn on the oscillatory device and informing the investigators when the first perception of vibration is felt. A recording of the frequency (1 kilo Hertz to 1 Hertz) will be documented.
  • 6. Vibration frequency detection threshold (when vibration is first felt) after IM Oxytocin injection [ Time Frame: 65 minutes ]
    Vibration frequency detection threshold in the burned area after IM Oxytocin injection will be obtained by the subject placing the forearm area that was exposed to the UV burn on the oscillatory device and informing the investigators when the first perception of vibration is felt. A recording of the frequency (1 kilo Hertz to 1 Hertz) will be documented.
  • 7. Vibration frequency detection threshold (when vibration is first felt) after IM Oxytocin injection [ Time Frame: 120 minutes ]
    Vibration frequency detection threshold in the burned area after IM Oxytocin injection will be obtained by the subject placing the forearm area that was exposed to the UV burn on the oscillatory device and informing the investigators when the first perception of vibration is felt. A recording of the frequency (1 kilo Hertz to 1 Hertz) will be documented.
  • 8. Vibration frequency detection threshold (when vibration is first felt) after IM Saline injection [ Time Frame: 5 minutes ]
    Vibration frequency detection threshold in the burned area after IM Saline injection (Placebo) will be obtained by the subject placing the forearm area that was exposed to the UV burn on the oscillatory device and informing the investigators when the first perception of vibration is felt. A recording of the frequency (1 kilo Hertz to 1 Hertz) will be documented.
  • 9. Vibration frequency detection threshold (when vibration is first felt) after IM Saline injection [ Time Frame: 15 minutes ]
    Vibration frequency detection threshold in the burned area after IM Saline injection (Placebo) will be obtained by the subject placing the forearm area that was exposed to the UV burn on the oscillatory device and informing the investigators when the first perception of vibration is felt. A recording of the frequency (1 kilo Hertz to 1 Hertz) will be documented.
  • 10. Vibration frequency detection threshold (when vibration is first felt) after IM Saline injection [ Time Frame: 30 minutes ]
    Vibration frequency detection threshold in the burned area after IM Saline injection (Placebo) will be obtained by the subject placing the forearm area that was exposed to the UV burn on the oscillatory device and informing the investigators when the first perception of vibration is felt. A recording of the frequency (1 kilo Hertz to 1 Hertz) will be documented.
  • 11. Vibration frequency detection threshold (when vibration is first felt) after IM Saline injection [ Time Frame: 45 minutes ]
    Vibration frequency detection threshold in the burned area after IM Saline injection (Placebo) will be obtained by the subject placing the forearm area that was exposed to the UV burn on the oscillatory device and informing the investigators when the first perception of vibration is felt. A recording of the frequency (1 kilo Hertz to 1 Hertz) will be documented.
  • 12. Vibration frequency detection threshold (when vibration is first felt) after IM Saline injection [ Time Frame: 60 minutes ]
    Vibration frequency detection threshold in the burned area after IM Saline injection (Placebo) will be obtained by the subject placing the forearm area that was exposed to the UV burn on the oscillatory device and informing the investigators when the first perception of vibration is felt. A recording of the frequency (1 kilo Hertz to 1 Hertz) will be documented.
  • 13. Vibration frequency detection threshold (when vibration is first felt) after IM Saline injection [ Time Frame: 65 minutes ]
    Vibration frequency detection threshold in the burned area after IM Saline injection (Placebo) will be obtained by the subject placing the forearm area that was exposed to the UV burn on the oscillatory device and informing the investigators when the first perception of vibration is felt. A recording of the frequency (1 kilo Hertz to 1 Hertz) will be documented.
  • 14. Vibration frequency detection threshold (when vibration is first felt) after IM Saline injection [ Time Frame: 120 minutes ]
    Vibration frequency detection threshold in the burned area after IM Saline injection (Placebo) will be obtained by the subject placing the forearm area that was exposed to the UV burn on the oscillatory device and informing the investigators when the first perception of vibration is felt. A recording of the frequency (1 kilo Hertz to 1 Hertz) will be documented.
  • 15. Pain threshold (the point where pain is first perceived) to a punctate mechanical stimulus after IM Oxytocin injection. [ Time Frame: 5 minutes ]
    Verbal pain punctate stimulus detection threshold (the point where pain is first perceived) in the burned area after IM Oxytocin injection will be obtained by using von Frey filaments (small filaments that are similar to a paint brush bristle). The skin will be touched with the filaments and the participant will state when pain is perceived and the size of the filament will be documented.
  • 16. Pain threshold (the point where pain is first perceived) to a punctate mechanical stimulus after IM Oxytocin injection. [ Time Frame: 15 minutes ]
    Verbal pain punctate stimulus detection threshold (the point where pain is first perceived) in the burned area after IM Oxytocin injection will be obtained by using von Frey filaments (small filaments that are similar to a paint brush bristle). The skin will be touched with the filaments and the participant will state when pain is perceived and the size of the filament will be documented.
  • 17. Hypersensitivity to von Frey filament (225 milliNewton) after IM Oxytocin Injection. [ Time Frame: 65 minutes ]
    Hypersensitivity in the burned area after IM Oxytocin injection will be obtained by using a von Frey filament (small filament that is similar to a paint brush bristle). The skin will be touched with the filament and the participant will state when sensitivity is perceived and the area marked and measured in centimeters squared
  • 18. Pain threshold (the point where pain is first perceived) to a punctate mechanical stimulus after IM Oxytocin injection. [ Time Frame: 30 minutes ]
    Verbal pain punctate stimulus detection threshold (the point where pain is first perceived) in the burned area after IM Oxytocin injection will be obtained by using von Frey filaments (small filaments that are similar to a paint brush bristle). The skin will be touched with the filaments and the participant will state when pain is perceived and the size of the filament will be documented.
  • 19. Pain threshold (the point where pain is first perceived) to a punctate mechanical stimulus after IM Oxytocin injection. [ Time Frame: 45 minutes ]
    Verbal pain punctate stimulus detection threshold (the point where pain is first perceived) in the burned area after IM Oxytocin injection will be obtained by using von Frey filaments (small filaments that are similar to a paint brush bristle). The skin will be touched with the filaments and the participant will state when pain is perceived and the size of the filament will be documented.
  • 20. Pain threshold (the point where pain is first perceived) to a punctate mechanical stimulus after IM Oxytocin injection. [ Time Frame: 60 minutes ]
    Verbal pain punctate stimulus detection threshold (the point where pain is first perceived) in the burned area after IM Oxytocin injection will be obtained by using von Frey filaments (small filaments that are similar to a paint brush bristle). The skin will be touched with the filaments and the participant will state when pain is perceived and the size of the filament will be documented.
  • 21. Pain threshold (the point where pain is first perceived) to a punctate mechanical stimulus after IM Oxytocin injection. [ Time Frame: 65 minutes ]
    Verbal pain punctate stimulus detection threshold (the point where pain is first perceived) in the burned area after IM Oxytocin injection will be obtained by using von Frey filaments (small filaments that are similar to a paint brush bristle). The skin will be touched with the filaments and the participant will state when pain is perceived and the size of the filament will be documented.
  • 22. Pain threshold (the point where pain is first perceived) to a punctate mechanical stimulus after IM Oxytocin injection. [ Time Frame: 120 minutes ]
    Verbal pain punctate stimulus detection threshold (the point where pain is first perceived) in the burned area after IM Oxytocin injection will be obtained by using von Frey filaments (small filaments that are similar to a paint brush bristle). The skin will be touched with the filaments and the participant will state when pain is perceived and the size of the filament will be documented.
  • 23. Pain threshold (the point where pain is first perceived) to a punctate mechanical stimulus after IM Saline injection (Placebo). [ Time Frame: 5 minutes ]
    Verbal pain punctate stimulus detection threshold (the point where pain is first perceived) in the burned area after IM Saline (Placebo) injection will be obtained by using von Frey filaments (small filaments that are similar to a paint brush bristle). The skin will be touched with the filaments and the participant will state when pain is perceived and the size of the filament will be documented.
  • 24. Pain threshold (the point where pain is first perceived) to a punctate mechanical stimulus after IM Saline injection (Placebo). [ Time Frame: 15 minutes ]
    Verbal pain punctate stimulus detection threshold (the point where pain is first perceived) in the burned area after IM Saline (Placebo) injection will be obtained by using von Frey filaments (small filaments that are similar to a paint brush bristle). The skin will be touched with the filaments and the participant will state when pain is perceived and the size of the filament will be documented.
  • 25. Pain threshold (the point where pain is first perceived) to a punctate mechanical stimulus after IM Saline injection (Placebo). [ Time Frame: 30 minutes ]
    Verbal pain punctate stimulus detection threshold (the point where pain is first perceived) in the burned area after IM Saline (Placebo) injection will be obtained by using von Frey filaments (small filaments that are similar to a paint brush bristle). The skin will be touched with the filaments and the participant will state when pain is perceived and the size of the filament will be documented.
  • 26. Pain threshold (the point where pain is first perceived) to a punctate mechanical stimulus after IM Saline injection (Placebo). [ Time Frame: 45 minutes ]
    Verbal pain punctate stimulus detection threshold (the point where pain is first perceived) in the burned area after IM Saline (Placebo) injection will be obtained by using von Frey filaments (small filaments that are similar to a paint brush bristle). The skin will be touched with the filaments and the participant will state when pain is perceived and the size of the filament will be documented.
  • 27. Pain threshold (the point where pain is first perceived) to a punctate mechanical stimulus after IM Saline injection (Placebo). [ Time Frame: 60 minutes ]
    Verbal pain punctate stimulus detection threshold (the point where pain is first perceived) in the burned area after IM Saline (Placebo) injection will be obtained by using von Frey filaments (small filaments that are similar to a paint brush bristle). The skin will be touched with the filaments and the participant will state when pain is perceived and the size of the filament will be documented.
  • 28. Pain threshold (the point where pain is first perceived) to a punctate mechanical stimulus after IM Saline injection (Placebo). [ Time Frame: 65 minutes ]
    Verbal pain punctate stimulus detection threshold (the point where pain is first perceived) in the burned area after IM Saline (Placebo) injection will be obtained by using von Frey filaments (small filaments that are similar to a paint brush bristle). The skin will be touched with the filaments and the participant will state when pain is perceived and the size of the filament will be documented.
  • 29. Pain threshold (the point where pain is first perceived) to a punctate mechanical stimulus after IM Saline injection (Placebo). [ Time Frame: 120 minutes ]
    Verbal pain punctate stimulus detection threshold (the point where pain is first perceived) in the burned area after IM Saline (Placebo) injection will be obtained by using von Frey filaments (small filaments that are similar to a paint brush bristle). The skin will be touched with the filaments and the participant will state when pain is perceived and the size of the filament will be documented.
  • 30. Hypersensitivity to von Frey filament (225 milliNewton) after IM Oxytocin Injection. [ Time Frame: 5 minutes ]
    Hypersensitivity in the burned area after IM Oxytocin injection will be obtained by using a von Frey filament (small filament that is similar to a paint brush bristle). The skin will be touched with the filament and the participant will state when sensitivity is perceived and the area marked and measured in centimeters squared.
  • 31. Hypersensitivity to von Frey filament (225 milliNewton) after IM Oxytocin Injection. [ Time Frame: 45 minutes ]
    Hypersensitivity in the burned area after IM Oxytocin injection will be obtained by using a von Frey filament (small filament that is similar to a paint brush bristle). The skin will be touched with the filament and the participant will state when sensitivity is perceived and the area marked and measured in centimeters squared.
  • 32. Hypersensitivity to von Frey filament (225 milliNewton) after IM Saline injection (Placebo). [ Time Frame: 5 minutes ]
    Hypersensitivity in the burned area after IM Saline (Placebo) injection will be obtained by using a von Frey filament (small filament that is similar to a paint brush bristle). The skin will be touched with the filament and the participant will state when sensitivity is perceived and the area marked and measured in centimeters squared.
  • 33. Hypersensitivity to von Frey filament (225 milliNewton) after IM Saline injection (Placebo). [ Time Frame: 45 minutes ]
    Hypersensitivity in the burned area after IM Saline (Placebo) injection will be obtained by using a von Frey filament (small filament that is similar to a paint brush bristle). The skin will be touched with the filament and the participant will state when sensitivity is perceived and the area marked and measured in centimeters squared.
  • 34. Hypersensitivity to von Frey filament (225 milliNewton) after IM Saline injection (Placebo). [ Time Frame: 65 minutes ]
    Hypersensitivity in the burned area after IM Saline (Placebo) injection will be obtained by using a von Frey filament (small filament that is similar to a paint brush bristle). The skin will be touched with the filament and the participant will state when sensitivity is perceived and the area marked and measured in centimeters squared.
  • 35. Vibration frequency detection of fixed frequency (when vibration is first felt) after IM Oxytocin injection [ Time Frame: 5 minutes ]
    Vibration frequency detection of a fixed frequency (256 Hertz) in the burned area after IM Oxytocin injection will be obtained. The subject will place the wrist area that was exposed to the UV burn on the oscillatory device, the fixed vibratory frequency will begin and will be increased in intensity and the subject will inform the investigators when the first perception of vibration is felt. A recording of the intensity level will be documented in Hertz.
  • 36. Vibration frequency detection of fixed frequency (when vibration is first felt) after IM Oxytocin injection [ Time Frame: 30 minutes ]
    Vibration frequency detection of a fixed frequency (256 Hertz) in the burned area after IM Oxytocin injection will be obtained. The subject will place the wrist area that was exposed to the UV burn on the oscillatory device, the fixed vibratory frequency will begin and will be increased in intensity and the subject will inform the investigators when the first perception of vibration is felt. A recording of the intensity level will be documented in Hertz.
  • 37. Vibration frequency detection of fixed frequency (when vibration is first felt) after IM Oxytocin injection [ Time Frame: 45 minutes ]
    Vibration frequency detection of a fixed frequency (256 Hertz) in the burned area after IM Oxytocin injection will be obtained. The subject will place the wrist area that was exposed to the UV burn on the oscillatory device, the fixed vibratory frequency will begin and will be increased in intensity and the subject will inform the investigators when the first perception of vibration is felt. A recording of the intensity level will be documented in Hertz .
  • 38. Vibration frequency detection of fixed frequency (when vibration is first felt) after IM Oxytocin injection [ Time Frame: 65 minutes ]
    Vibration frequency detection of a fixed frequency (256 Hertz) in the burned area after IM Oxytocin injection will be obtained. The subject will place the wrist area that was exposed to the UV burn on the oscillatory device, the fixed vibratory frequency will begin and will be increased in intensity and the subject will inform the investigators when the first perception of vibration is felt. A recording of the intensity level will be documented in Hertz.
  • 39. Vibration frequency detection of fixed frequency (when vibration is first felt) after IM Saline injection [ Time Frame: 5 minutes ]
    Vibration frequency detection of a fixed frequency (256 Hertz) in the burned area after IM Oxytocin injection will be obtained. The subject will place the wrist area that was exposed to the UV burn on the oscillatory device, the fixed vibratory frequency will begin and will be increased in intensity and the subject will inform the investigators when the first perception of vibration is felt. A recording of the intensity level will be documented in Hertz .
  • 40. Vibration frequency detection of fixed frequency (when vibration is first felt) after IM Saline injection [ Time Frame: 30 minutes ]
    Vibration frequency detection of a fixed frequency (256 Hertz) in the burned area after IM Oxytocin injection will be obtained. The subject will place the wrist area that was exposed to the UV burn on the oscillatory device, the fixed vibratory frequency will begin and will be increased in intensity and the subject will inform the investigators when the first perception of vibration is felt. A recording of the intensity level will be documented in Hertz .
  • 41. Vibration frequency detection of fixed frequency (when vibration is first felt) after IM Saline injection [ Time Frame: 45 minutes ]
    Vibration frequency detection of a fixed frequency (256 Hertz) in the burned area after IM Oxytocin injection will be obtained. The subject will place the wrist area that was exposed to the UV burn on the oscillatory device, the fixed vibratory frequency will begin and will be increased in intensity and the subject will inform the investigators when the first perception of vibration is felt. A recording of the intensity level will be documented in Hertz .
  • 42. Vibration frequency detection of fixed frequency (when vibration is first felt) after IM Saline injection [ Time Frame: 65 minutes ]
    Vibration frequency detection of a fixed frequency (256 Hertz) in the burned area after IM Oxytocin injection will be obtained. The subject will place the wrist area that was exposed to the UV burn on the oscillatory device, the fixed vibratory frequency will begin and will be increased in intensity and the subject will inform the investigators when the first perception of vibration is felt. A recording of the intensity level will be documented in Hertz.
  • Secondary Outcome Measures: 1. Sustained heat after IM Oxytocin injection non dominant arm [ Time Frame: 25 minutes ]
    Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 45 degree Celsius temperature after IM Oxytocin injection.
  • 2. Sustained heat after IM Oxytocin injection non dominant arm [ Time Frame: 21 minutes ]
    Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 45 degree Celsius temperature after IM Oxytocin injection.
  • 3. Sustained heat after IM Oxytocin injection non dominant arm [ Time Frame: 22 minutes ]
    Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 45 degree Celsius temperature after IM Oxytocin injection.
  • 4. Sustained heat after IM Oxytocin injection non dominant arm [ Time Frame: 23 minutes ]
    Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 45 degree Celsius temperature after IM Oxytocin injection.
  • 5. Sustained heat after IM Oxytocin injection non dominant arm [ Time Frame: 24 minutes ]
    Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 45 degree Celsius temperature after IM Oxytocin injection.
  • 6. Sustained heat after IM Oxytocin injection non dominant arm [ Time Frame: 41 minutes ]
    Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 45 degree Celsius temperature after IM Oxytocin injection.
  • 7. Sustained heat after IM Oxytocin injection non dominant arm [ Time Frame: 42 minutes ]
    Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 45 degree Celsius temperature after IM Oxytocin injection.
  • 8. Sustained heat after IM Oxytocin injection non dominant arm [ Time Frame: 43 minutes ]
    Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 45 degree Celsius temperature after IM Oxytocin injection.
  • 9. Sustained heat after IM Oxytocin injection non dominant arm [ Time Frame: 44 minutes ]
    Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 45 degree Celsius temperature after IM Oxytocin injection.
  • 10. Sustained heat after IM Oxytocin injection non dominant arm [ Time Frame: 45 minutes ]
    Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 45 degree Celsius temperature after IM Oxytocin injection.
  • 11. Sustained heat after IM Oxytocin injection non dominant arm [ Time Frame: 61 minutes ]
    Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 45 degree Celsius temperature after IM Oxytocin injection.
  • 12. Sustained heat after IM Oxytocin injection non dominant arm [ Time Frame: 62 minutes ]
    Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 45 degree Celsius temperature after IM Oxytocin injection.
  • 13. Sustained heat after IM Oxytocin injection non dominant arm [ Time Frame: 63 minutes ]
    Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 45 degree Celsius temperature after IM Oxytocin injection.
  • 14. Sustained heat after IM Oxytocin injection non dominant arm [ Time Frame: 64 minutes ]
    Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 45 degree Celsius temperature after IM Oxytocin injection.
  • 15. Sustained heat after IM Oxytocin injection non dominant arm [ Time Frame: 65 minutes ]
    Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 45 degree Celsius temperature after IM Oxytocin injection.
  • 16. Sustained heat after IM Oxytocin injection non dominant arm [ Time Frame: 121 minutes ]
    Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 45 degree Celsius temperature after IM Oxytocin injection.
  • 17. Sustained heat after IM Oxytocin injection non dominant arm [ Time Frame: 122 minutes ]
    Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 45 degree Celsius temperature after IM Oxytocin injection.
  • 18. Sustained heat after IM Oxytocin injection non dominant arm [ Time Frame: 123 minutes ]
    Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 45 degree Celsius temperature after IM Oxytocin injection.
  • 19. Sustained heat after IM Oxytocin injection non dominant arm [ Time Frame: 124 minutes ]
    Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 45 degree Celsius temperature after IM Oxytocin injection.
  • 20. Sustained heat after IM Oxytocin injection non dominant arm [ Time Frame: 125 minutes ]
    Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 45 degree Celsius temperature after IM Oxytocin injection.
  • 21. Sustained heat after IM Saline injection (placebo) non dominant arm [ Time Frame: 21 minutes ]
    Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 45 degree Celsius temperature after IM Saline injection (placebo).
  • 22. Sustained heat after IM Saline injection (placebo) non dominant arm [ Time Frame: 22 minutes ]
    Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 45 degree Celsius temperature after IM Saline injection (placebo).
  • 23. Sustained heat after IM Saline injection (placebo) non dominant arm [ Time Frame: 23 minutes ]
    Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 45 degree Celsius temperature after IM Saline injection (placebo).
  • 24. Sustained heat after IM Saline injection (placebo) non dominant arm [ Time Frame: 24 minutes ]
    Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 45 degree Celsius temperature after IM Saline injection (placebo).
  • 25. Sustained heat after IM Saline injection (placebo) non dominant arm [ Time Frame: 25 minutes ]
    Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 45 degree Celsius temperature after IM Saline injection (placebo).
  • 26. Sustained heat after IM Saline injection (placebo) non dominant arm [ Time Frame: 41 minutes ]
    Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 45 degree Celsius temperature after IM Saline injection (placebo).
  • 27. Sustained heat after IM Saline injection (placebo) non dominant arm [ Time Frame: 42 minutes ]
    Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 45 degree Celsius temperature after IM Saline injection (placebo).
  • 28. Sustained heat after IM Saline injection (placebo) non dominant arm [ Time Frame: 43 minutes ]
    Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 45 degree Celsius temperature after IM Saline injection (placebo).
  • 29. Sustained heat after IM Saline injection (placebo) non dominant arm [ Time Frame: 44 minutes ]
    Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 45 degree Celsius temperature after IM Saline injection (placebo).
  • 30. Sustained heat after IM Saline injection (placebo) non dominant arm [ Time Frame: 45 minutes ]
    Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 45 degree Celsius temperature after IM Saline injection (placebo).
  • 31. Sustained heat after IM Saline injection (placebo) non dominant arm [ Time Frame: 61 minutes ]
    Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 45 degree Celsius temperature after IM Saline injection (placebo).
  • 32. Sustained heat after IM Saline injection (placebo) non dominant arm [ Time Frame: 62 minutes ]
    Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 45 degree Celsius temperature after IM Saline injection (placebo).
  • 33. Sustained heat after IM Saline injection (placebo) non dominant arm [ Time Frame: 63 minutes ]
    Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 45 degree Celsius temperature after IM Saline injection (placebo).
  • 34. Sustained heat after IM Saline injection (placebo) non dominant arm [ Time Frame: 64 minutes ]
    Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 45 degree Celsius temperature after IM Saline injection (placebo).
  • 35. Sustained heat after IM Saline injection (placebo) non dominant arm [ Time Frame: 65 minutes ]
    Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 45 degree Celsius temperature after IM Saline injection (placebo).
  • 36. Sustained heat after IM Saline injection (placebo) non dominant arm [ Time Frame: 121 minutes ]
    Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 45 degree Celsius temperature after IM Saline injection (placebo).
  • 37. Sustained heat after IM Saline injection (placebo) non dominant arm [ Time Frame: 122 minutes ]
    Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 45 degree Celsius temperature after IM Saline injection (placebo).
  • 38. Sustained heat after IM Saline injection (placebo) non dominant arm [ Time Frame: 123 minutes ]
    Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 45 degree Celsius temperature after IM Saline injection (placebo).
  • 39. Sustained heat after IM Saline injection (placebo) non dominant arm [ Time Frame: 124 minutes ]
    Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 45 degree Celsius temperature after IM Saline injection (placebo).
  • 40. Sustained heat after IM Saline injection (placebo) non dominant arm [ Time Frame: 125 minutes ]
    Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 45 degree Celsius temperature after IM Saline injection (placebo).
  • 41. Sustained heat after IM Oxytocin injection [ Time Frame: 36 minutes ]
    Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 40 degree Celsius temperature applied to the site of the UV burn after IM Oxytocin injection.
  • 42. Sustained heat after IM Oxytocin injection [ Time Frame: 37 minutes ]
    Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 40 degree Celsius temperature applied to the site of the UV burn after IM Oxytocin injection.
  • 43. Sustained heat after IM Oxytocin injection [ Time Frame: 38 minutes ]
    Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 40 degree Celsius temperature applied to the site of the UV burn after IM Oxytocin injection.
  • 44. Sustained heat after IM Oxytocin injection [ Time Frame: 39 minutes ]
    Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 40 degree Celsius temperature applied to the site of the UV burn after IM Oxytocin injection.
  • 45. Sustained heat after IM Oxytocin injection [ Time Frame: 40 minutes ]
    Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 40 degree Celsius temperature applied to the site of the UV burn after IM Oxytocin injection.
  • 46. Sustained heat after IM Saline (placebo) injection [ Time Frame: 36 minutes ]
    Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 40 degree Celsius temperature applied to the site of the UV burn after IM Saline injection (placebo).
  • 47. Sustained heat after IM Saline (placebo) injection [ Time Frame: 37 minutes ]
    Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 40 degree Celsius temperature applied to the site of the UV burn after IM Saline injection (placebo).
  • 48. Sustained heat after IM Saline (placebo) injection [ Time Frame: 38 minutes ]
    Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 40 degree Celsius temperature applied to the site of the UV burn after IM Saline injection (placebo).
  • 49. Sustained heat after IM Saline (placebo) injection [ Time Frame: 39 minutes ]
    Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 40 degree Celsius temperature applied to the site of the UV burn after IM Saline injection (placebo).
  • 50. Sustained heat after IM Saline (placebo) injection [ Time Frame: 40 minutes ]
    Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 40 degree Celsius temperature applied to the site of the UV burn after IM Saline injection (placebo).
  • 51. Sustained heat after IM Oxytocin injection (lower leg) [ Time Frame: 21 minutes ]
    Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 45 degree Celsius temperature applied to the calf (lower leg) after IM Oxytocin injection.
  • 52. Sustained heat after IM Oxytocin injection (lower leg) [ Time Frame: 22 minutes ]
    Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 45 degree Celsius temperature applied to the calf (lower leg) after IM Oxytocin injection.
  • 53. Sustained heat after IM Oxytocin injection (lower leg) [ Time Frame: 23 minutes ]
    Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 45 degree Celsius temperature applied to the calf (lower leg) after IM Oxytocin injection.
  • 54. Sustained heat after IM Oxytocin injection (lower leg) [ Time Frame: 24 minutes ]
    Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 45 degree Celsius temperature applied to the calf (lower leg) after IM Oxytocin injection.
  • 55. Sustained heat after IM Oxytocin injection (lower leg) [ Time Frame: 25 minutes ]
    Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 45 degree Celsius temperature applied to the calf (lower leg) after IM Oxytocin injection.
  • 56. Sustained heat after IM Saline (placebo) injection (lower leg) [ Time Frame: 21 minutes ]
    Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 45 degree Celsius temperature applied to the calf (lower leg) after IM Saline injection.
  • 57. Sustained heat after IM Saline (placebo) injection (lower leg) [ Time Frame: 22 minutes ]
    Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 45 degree Celsius temperature applied to the calf (lower leg) after IM Saline injection.
  • 58. Sustained heat after IM Saline (placebo) injection (lower leg) [ Time Frame: 23 minutes ]
    Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 45 degree Celsius temperature applied to the calf (lower leg) after IM Saline injection.
  • 59. Sustained heat after IM Saline (placebo) injection (lower leg) [ Time Frame: 24 minutes ]
    Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 45 degree Celsius temperature applied to the calf (lower leg) after IM Saline injection.
  • 60. Sustained heat after IM Saline (placebo) injection (lower leg) [ Time Frame: 25 minutes ]
    Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 45 degree Celsius temperature applied to the calf (lower leg) after IM Saline injection.
  • 61. Sustained heat after IM Oxytocin injection (lower leg) [ Time Frame: 61 minutes ]
    Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 45 degree Celsius temperature applied to the calf (lower leg) after IM Oxytocin injection.
  • 62. Sustained heat after IM Oxytocin injection (lower leg) [ Time Frame: 62 minutes ]
    Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 45 degree Celsius temperature applied to the calf (lower leg) after IM Oxytocin injection.
  • 63. Sustained heat after IM Oxytocin injection (lower leg) [ Time Frame: 63 minutes ]
    Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 45 degree Celsius temperature applied to the calf (lower leg) after IM Oxytocin injection.
  • 64. Sustained heat after IM Oxytocin injection (lower leg) [ Time Frame: 64 minutes ]
    Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 45 degree Celsius temperature applied to the calf (lower leg) after IM Oxytocin injection.
  • 65. Sustained heat after IM Oxytocin injection (lower leg) [ Time Frame: 65 minutes ]
    Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 45 degree Celsius temperature applied to the calf (lower leg) after IM Oxytocin injection.
  • 66. Sustained heat after IM Saline (placebo) injection (lower leg) [ Time Frame: 61 minutes ]
    Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 45 degree Celsius temperature applied to the calf (lower leg) after IM Saline injection.
  • 67. Sustained heat after IM Saline (placebo) injection (lower leg) [ Time Frame: 62 minutes ]
    Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 45 degree Celsius temperature applied to the calf (lower leg) after IM Saline injection.
  • 68. Sustained heat after IM Saline (placebo) injection (lower leg) [ Time Frame: 63 minutes ]
    Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 45 degree Celsius temperature applied to the calf (lower leg) after IM Saline injection.
  • 69. Sustained heat after IM Saline (placebo) injection (lower leg) [ Time Frame: 64 minutes ]
    Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 45 degree Celsius temperature applied to the calf (lower leg) after IM Saline injection.
  • 70. Sustained heat after IM Saline (placebo) injection (lower leg) [ Time Frame: 65 minutes ]
    Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 45 degree Celsius temperature applied to the calf (lower leg) after IM Saline injection.
Eligibility Criteria
  • Ages Eligible for Study: 18 to 60 Years (Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: Yes
Criteria

Inclusion Criteria:

- Male or female > 18 and < 60 years of age, - Body Mass Index (BMI) <40 - Generally in good health as determined by the Principal Investigator based on prior medical history - Normal blood pressure and resting heart rate without medication Exclusion Criteria: - Hypersensitivity, allergy, or significant reaction to any ingredient of Pitocin® - Any disease, diagnosis, or condition (medical or surgical) that, in the opinion of the Principal Investigator, would place the subject at increased risk - Women who are pregnant (positive result for serum pregnancy test at screening visit), women who are currently nursing or lactating, women that have been pregnant within 2 years. - Neuropathy, chronic pain, diabetes mellitus, or taking benzodiazepines or pain medications on a daily basis.

Contacts and Locations
Contacts
Locations

United States, North Carolina
Wake Forest Baptist Health
Winston-Salem

Sponsors and Collaborators

Wake Forest University Health Sciences

Investigators

Principal Investigator: James C Eisenach, MD Wake Forest University Health Sciences

More Information
  • Responsible Party: Wake Forest University Health Sciences
  • ClinicalTrials.gov Identifier: NCT03935399 History of Changes
  • Other Study ID Numbers: IRB00056660
  • First Posted: May 2, 2019 Key Record Dates
  • Last Update Posted: August 21, 2020
  • Last Verified: July 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Product Manufactured in and Exported from the U.S.: Yes
  • Additional relevant MeSH terms: Chronic Pain