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

What Was Tested

In this phase 4 trial, researchers set out to test Oxytocin for chronic pain: fibromyalgia & crps.

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.

It had two arms (groups): Oxytocin first, then saline placebo (other) and Saline placebo first, then oxytocin (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

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.

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.

Who Took Part

10 actual participants took part.

It was open to people of any sex aged from 18 years up to 60 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Male or female \> 18 and \< 60 years of age,. Body Mass Index (BMI) \<40. Normal blood pressure and resting heart rate without medication.

The full record lists 4 inclusion and 4 exclusion criteria; among the exclusions: neuropathy, chronic pain, diabetes mellitus, or taking benzodiazepines or pain medications on a daily basis.

How the Study Was Run

The set-up was randomized, crossover and triple-blind.

Because people in this Oxytocin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

In the crossover set-up each of the chronic pain: fibromyalgia & crps participants took both Oxytocin and the comparison in turn, acting as their own control.

Blinding on both sides kept the chronic pain: fibromyalgia & crps participants and researchers unaware of who received Oxytocin.

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It started in 2019-08-08 with completion listed for 2020-03-15.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

It also tracked 3 secondary outcomes, for example Change in Sustained Heat After IM Injection Non Dominant Arm, Change in Sustained Heat After IM Injection and Change in Sustained Heat After IM Oxytocin or Placebo Injection (Lower Leg).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Oxytocin in 10 people with chronic pain: fibromyalgia & crps.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Oxytocin compound page, Chronic pain: fibromyalgia & CRPS research.