Evaluating the Efficacy of Intranasal Oxytocin Among Individuals With Persistent Pain

What Was Tested

In this phase 2, phase 3 trial, researchers set out to test Oxytocin for chronic pain: fibromyalgia & crps.

This study is a placebo-controlled, double-blind, within-participants crossover investigation of the effect of intranasal oxytocin on pain and function among women with chronic pelvic pain.

It had two arms (groups): Intranasal Oxytocin (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

Rationale: Oxytocin (OT) is a neuropeptide produced in the supraoptic and paraventricular nuclei of the hypothalamus.

In brief, the first mechanism involves spinal signaling.

A direct hypothalamo-spinal projection originating from the paraventricular nucleus transports OT, to the dorsal horn (Lamina-I, II, and IV), an area containing OT receptors that influence glutamate and GABA cellular signaling.

The second mechanism involves an indirect pathway via the endogenous opioids.

Who Took Part

24 actual participants took part.

It was open to women only aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

The full record lists 1 inclusion and 1 exclusion criteria.

How the Study Was Run

Design: 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.

Each person switched between Oxytocin and the comparison at some point, usually with a gap in between.

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

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

It started in 2016-11 with completion listed for 2018-12.

It ran at 1 site in Canada.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Self-reported pain (time frame: 14-days).

It also tracked 3 secondary outcomes, for example Self-report positive and negative affect, Self-report depressed mood, anxious mood, and stress and Self-report sleep.

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of Oxytocin in 24 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; no results are posted to the registry yet, so nothing here describes outcomes.

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