Protocol for a placebo-controlled, within-participants crossover trial evaluating the efficacy of intranasal oxytocin to improve pain and function among women with chronic pelvic musculoskeletal pain

What Was Tested

Researchers studied Oxytocin in the context of chronic pain: fibromyalgia & crps in this randomized controlled trial publication.

Oxytocin is a neuropeptide traditionally recognised for involvement in labour, delivery and lactation.

While oxytocin administration has been reported to lower pain sensitivity among patients experiencing chronic back pain, headache, constipation and colon pain, no research has evaluated the association between intranasal oxytocin and chronic pelvic musculoskeletal pain.

Who Took Part

The study group was 50 women.

By PubMed's age tags, the people studied were adults, women only.

This is a prospective, randomised, placebo-controlled, double-blind, within-participants crossover trial. 50 women with chronic pelvic musculoskeletal pain will be recruited through a local chronic pain centre and gynaecology clinics.

Women will then undergo a 2-week washout period before crossing over to receive the condition that they had not yet received.

How the Study Was Run

The design is described as randomized, double-blind, placebo-controlled and crossover.

The women were allocated by chance, so the Oxytocin group and the comparison group should start out alike.

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

Some women received a placebo instead of Oxytocin, giving a reference point.

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

The primary outcome will be pain and function measured using the Brief Pain Inventory-Short Form.

Secondary outcomes include emotional function, sleep disturbance and global impression of change.

This trial will provide data on the 14-day safety and side-effect profile of intranasal oxytocin self-administered as an adjuvant treatment for chronic pelvic musculoskeletal pain.

What Was Measured

While oxytocin administration has been reported to lower pain sensitivity among patients experiencing chronic back pain, headache, constipation and colon pain, no research has evaluated the association between intranasal oxytocin and chronic pelvic musculoskeletal pain.

PubMed files the paper under topics including Canada, Chronic Pain, Musculoskeletal Pain, Oxytocin, Pain Threshold, Pelvic Pain and Self Report.

Author keywords: Analgesia, Chronic Pelvic Pain, PAIN MANAGEMENT and Randomized Controlled Trial.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Oxytocin in 50 women in people with chronic pain: fibromyalgia & crps.

The publication is from 2017 (BMJ open), a journal based in England.

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