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

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dc.contributor.authorRash, Joshua A
dc.contributor.authorToivonen, Kirsti
dc.contributor.authorRobert, Magali
dc.contributor.authorNasr-Esfahani, Maryam
dc.contributor.authorJarrell, John F
dc.contributor.authorCampbell, Tavis S
dc.date.accessioned2017-04-19T22:40:34Z
dc.date.available2017-04-19T22:40:34Z
dc.date.issued2017
dc.descriptionArticle sponsored by the University of Calgary Open Access Authors Funden_US
dc.description.abstractIntroduction 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.en_US
dc.description.refereedYesen_US
dc.identifier.citationRash JA, Toivonen K, Robert M, et al. Protocol for a placebocontrolled, within-participants crossover trial evaluating the efficacy of intranasal oxytocin to improve pain and function among women with chronic pelvic musculoskeletal pain. BMJ Open 2017;7:e014909. doi:10.1136/bmjopen-2016- 014909en_US
dc.identifier.doi10.1136/bmjopen-2016- 014909
dc.identifier.doihttp://dx.doi.org/10.11575/PRISM/33357
dc.identifier.urihttp://hdl.handle.net/1880/51961
dc.language.isoenen_US
dc.publisherBMJen_US
dc.publisher.corporateUniversity of Calgary
dc.publisher.departmentPsychologyen_US
dc.publisher.facultyArtsen_US
dc.publisher.institutionUniversity of Calgaryen_US
dc.rightsAttribution Non-Commercial 4.0 International*
dc.rights.urihttp://creativecommons.org/licenses/by-nc/4.0/*
dc.titleProtocol 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 painen_US
dc.typejournal article
thesis.degree.disciplinePsychology
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