Evaluating the Efficacy of Intranasal Oxytocin Among Individuals With Persistent Pain

• Status: Unknown status
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Calgary
• Treatments: Oxytocin

Criteria

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.