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Trial · Interventional

CompletedPhase 2/3Registry data

Evaluating the Efficacy of Intranasal Oxytocin Among Individuals With Persistent Pain

Overview

Status
Completed
Phase
Phase 2/3
Enrollment
24 participants (actual)
Sponsor
University of Calgary · Other
Design
Randomized · Triple masking
Countries
1 country

Canada

Start
Nov 2016
Primary completion
Dec 2018
Completion
Dec 2018
First posted
5 Sept 2016 (estimated)
Last update posted
18 May 2022
Conditions
Chronic Pain · Pelvic Pain

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2016201720182019
  1. Ph 2/3

    Evaluating the Efficacy of Intranasal Oxytocin Among Individuals With Persistent Pain

    NCT02888574

    Nov 2016 to Dec 2018

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Intranasal OxytocinDrug
  • PlaceboDrug

Arms2

  • Experimental

    Intranasal Oxytocin

    Oxytocin nasal spray delivered bi-daily over a 14-day period at 24-IU per dose

  • Placebo comparator

    Placebo

    Placebo nasal spray containing the same ingredients as the active nasal spray minus the oxytocin and packaged in an identical bottle. To be delivered bi-daily over a 14-day period at 24-IU per dose

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Self-reported pain

    Time frame · 14-days

    Registry description

    The Brief Pain Inventory - Short Form

Secondary outcomes(3)
  1. Self-report positive and negative affect

    Time frame · 14-days

    Registry description

    Positive and Negative Affect Scale

  2. Self-report depressed mood, anxious mood, and stress

    Time frame · 14-day

    Registry description

    Depression Anxiety Stress Scale

  3. Self-report sleep

    Time frame · 14-day

    Registry description

    Medical Outcomes Study Sleep Scale

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2021

5 results

Intranasal oxytocin as a treatment for chronic pelvic pain: A randomized controlled feasibility study.

Flynn et al. 2021International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetricscited by 16

PMID 33112417DOI 10.1002/ijgo.13441PUB-33112417

Full text at the publisher5 results

Indexing hint: Randomized controlled trial · 2017

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.

Rash et al. 2017BMJ opencited by 4

PMID 28416501PMC5775465DOI 10.1136/bmjopen-2016-014909PUB-28416501

Free to read · publisher termsCC BY-NC
Read at source

Eligibility

Who could join, as posted.

Sex
Female
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Non-menopausal women with chronic pelvic musculoskeletal pain (i.e., pain exceeding 6-months in duration that is located primarily in the pelvic region and reproducible on palpation to the muscles spanning the pelvic floor) will be eligible to participate if they: 1) have regular menstrual periods (monthly within a 21-35 day range); 2) using a permanent or barrier form of contraception; 3) can commit not to change their medication during the 6-weeks of this study; and 4) have a moderate amount of pain at baseline (i.e., a pain score of 4-7 out of 10 on a numeric rating scale). A baseline pain score of 4-7 out of 10 was selected to prevent floor and ceiling effects and ensure that participants have room to change throughout the course of the study. Exclusion Criteria: * Muscle pain as a result of systemic disease, scoring positive on a urine pregnancy test, concurrent use of another nasal spray, nasal pathology (e.g., ears, nose, and throat diagnosis), diabetes insipidus, previous or concurrent use of narcotics delivered intranasally (e.g., cocaine), are contemplating pregnancy, or who have sacroiliac instability as defined by the European Guidelines. Women will also be excluded with they have a primary diagnosis of endometriosis, dysmenorrhea, interstitial cystitis, functional bowel disorder, fibromyalgia or neuropathic pain.

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