You are here

  • Home
  • Archive
  • Volume 7, Issue 4
  • 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

Article Text

Article menu

Download PDFPDF

XML
Pharmacology and therapeutics
Protocol
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
  1. Joshua A Rash1,2,
  2. Kirsti Toivonen1,
  3. Magali Robert3,
  4. Maryam Nasr-Esfahani3,
  5. John F Jarrell3,
  6. Tavis S Campbell1
  1. 1Department of Psychology, University of Calgary, Calgary, Alberta, Canada
  2. 2Department of Psychology, Memorial University of Newfoundland, St. John's, Newfoundland, Canada
  3. 3Department of Obstetrics and Gynecology, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada
  1. Correspondence to Dr Tavis S Campbell; t.s.campbell{at}ucalgary.ca

Abstract

Introduction This protocol presents the rationale and design for a trial evaluating the efficacy of intranasal oxytocin in improving pain and function among women with chronic pelvic musculoskeletal pain. Oxytocin is a neuropeptide traditionally recognised for involvement in labour, delivery and lactation. Novel evidence suggests that oxytocin decreases pain sensitivity in humans. 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. The association between oxytocin and pain may differ in women with chronic pelvic musculoskeletal pain relative to other chronic pain conditions because of the abundance of oxytocin receptors in the uterus.

Methods and analysis 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 complete baseline measures and be randomised to an experimental or control condition that involve 2 weeks of self-administering twice-daily doses of 24 IU intranasal oxytocin or placebo, respectively. Women will then undergo a 2-week washout period before crossing over to receive the condition that they had not yet received. 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.

Ethics and dissemination This trial was granted approval from Health Canada and the University of Calgary Conjoint Health Research Ethics Board, and is registered online at ClinicalTrials.gov (#NCT02888574). Results will be disseminated to healthcare professionals through peer-reviewed publications and to the general public through press releases.

Trial registration number NCT02888574; Pre-results.

  • Oxytocin
  • PAIN MANAGEMENT
  • Randomized Controlled Trial
  • Chronic Pelvic Pain
  • Analgesia

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

https://doi.org/10.1136/bmjopen-2016-014909

Statistics from Altmetric.com

    Request Permissions

    If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.

    View Full Text

    Footnotes

    • Funding This work is supported by an operating grant awarded by the University of Calgary Clinical Research Fund (project# 10015623).

    • Competing interests None declared.

    • Ethics approval This study has been approved by the University of Calgary Conjoint Health Research Ethics Board (CHREB) and Health Canada.

    • Provenance and peer review Not commissioned; externally peer reviewed.