Evaluating the Efficacy of Intranasal Oxytocin Among Individuals With Persistent Pain

NCT02888574 | Completed Phase 2

• 1 other identifier: CHREB16-0334
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Pain; Pelvic Pain

Outcome Measures

Primary Outcomes (1)

• Self-reported pain

  The Brief Pain Inventory - Short Form

  14-days

Secondary Outcomes (3)

• Self-report positive and negative affect

  14-days

• Self-report depressed mood, anxious mood, and stress

  14-day

• Self-report sleep

  14-day

Study Arms (2)

Intranasal Oxytocin

EXPERIMENTAL

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

Drug: Intranasal Oxytocin

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Intranasal Oxytocin DRUG

Intranasal oxytocin (Syntocinon; Novartis, Switzerland)

Also known as: Syntocinon

Intranasal Oxytocin

Placebo DRUG

Placebo nasal spray

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

Behavioural Medicine Laboratory

Calgary, Alberta, T2N 1N4, Canada

Location

Related Publications (2)

• Flynn MJ, Campbell TS, Robert M, Nasr-Esfahani M, Rash JA. Intranasal oxytocin as a treatment for chronic pelvic pain: A randomized controlled feasibility study. Int J Gynaecol Obstet. 2021 Mar;152(3):425-432. doi: 10.1002/ijgo.13441. Epub 2020 Dec 8.

  PMID: 33112417 DERIVED

• Rash JA, Toivonen K, Robert M, Nasr-Esfahani M, Jarrell JF, Campbell TS. 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. BMJ Open. 2017 Apr 16;7(4):e014909. doi: 10.1136/bmjopen-2016-014909.

  PMID: 28416501 DERIVED

MeSH Terms

Conditions

Chronic Pain; Pelvic Pain

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Tavis S Campbell, PhD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 30, 2016
• First Posted: September 5, 2016
• Study Start: November 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: May 18, 2022

Record last verified: 2022-05

Locations

CA (1)