Efficacy of Intrathecal Oxytocin in Patients With Neuropathic Pain

What Was Tested

This registered phase 2 trial tested Oxytocin.

The purpose of the study is to determine the effect of oxytocin given into the spinal fluid on pain and areas and intensity of hyperalgesia and allodynia in patients with chronic neuropathic pain.

It had two arms (groups): Oxytocin, then Placebo (experimental) and Placebo, then Oxytocin (experimental).

The registry classes the interventions as drug.

More on the Plan

Objectives: Determine the effect of intrathecal oxytocin on pain and areas and intensity of hyperalgesia and allodynia in patients with chronic neuropathic pain.

Interventions: A computer generated randomization will be used to determine the group for each subject.

Subjects will be randomized to receive an intrathecal injection of saline (placebo) or oxytocin.

Who Took Part

The registry lists 8 actual participants took part.

It was open to people of any sex aged from 18 years up to 70 years.

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

Examples of who could join: Weight \< or equal to 240 pounds. Neuropathic pain for \> 6 months: with primary pain area below the umbilicus.

The full record lists 2 inclusion and 4 exclusion criteria.

How the Study Was Run

Design: randomized, crossover and triple-blind.

Random assignment meant chance, not the researchers, decided who got Oxytocin and who got the comparison, which limits bias.

In the crossover set-up each of the participants took both Oxytocin and the comparison in turn, acting as their own control.

As a double-blind Oxytocin study, the assignments were hidden from both participants and investigators until the end.

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

It started in 2014-06-19 with completion listed for 2022-10-10.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: Spontaneous Pain From Their Neuropathic Pain Disease (time frame: 240 minutes post injection).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Oxytocin in 8 people.

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

It ended early (terminated); results are posted on the registry, and this page does not restate them.

More context: the Oxytocin compound page, all human trials.