Chronic PainPhase 2/3NCT02888574
Evaluating the Efficacy of Intranasal Oxytocin Among Individuals With Persistent Pain
A Phase 2/3 study testing Intranasal Oxytocin in people with Chronic Pain and Pelvic Pain, run by University of Calgary at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Chronic Pain, Pelvic Pain
- What is being tested?
- Intranasal Oxytocin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2016to Dec 2018
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
- Rationale: Oxytocin (OT) is a neuropeptide produced in the supraoptic and paraventricular nuclei of the hypothalamus. There exists at least three plausible mechanisms through which OT may decrease pain sensitivity. In brief, the first mechanism involves spinal signaling. A direct hypothalamo-spinal projection originating from the paraventricular nucleus transports OT, to the dorsal horn (Lamina-I, II, and IV), an area containing OT receptors that influence glutamate and GABA cellular signaling. The second mechanism involves an indirect pathway via the endogenous opioids. Evidence suggests that OT binds to opioid receptors and may also stimulate endogenous opioid release in the brain. Finally, OT may decrease pain by improving mood, decreasing anxiety, and mitigating the stress response. Thirty-three animal investigations have assessed OT-pain relationships with 29 reporting that exogenous administration and higher endogenous levels decreased pain. There is a lack of clarity of an OT-pain association in the human literature due to a paucity of methodologically rigorous trials. Thus far, OT administration has been reported to lower pain sensitivity among patients experiencing chronic back pain, headache, constipation, and colon pain. To date, no research has evaluated the association between intranasal OT and chronic pelvic pain. The association between OT and pain may be different in women with pelvic pain relative to other chronic pain conditions because of a potential peripheral OT-pain pathway. There is an abundance of OT receptors in the uterus, and OT is a potent uterogenic agent that is clinically used in large doses to stimulate uterine contractions and induce labor. While OT does not cross the blood-brain-barrier, the central administration of intranasal OT increases central and blood-plasma OT concentrations. Thus, intranasal OT administration may be associated with pain through central and peripheral pathways; however uterine contractions with 24IU doses of intranasal OT occur in only 1 in every 100-1000 people.
- Research questions and objectives: This research is a pilot study of the efficacy of intranasal OT at improving pain and function among women with chronic pelvic pain of primarily musculoskeletal origin.
- Design: This study will utilize a double-blind, placebo-controlled, within-subjects crossover design. Participants will complete 6-weeks of testing consisting of two 2-week intranasal administrations separated by a 2-week washout period
- Conditions
- Chronic Pain, Pelvic Pain
- Being tested
- Intranasal Oxytocin, Placebo
- Medical subject headings
- Chronic Pain, Pelvic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intranasal OxytocinDrug
Also called Syntocinon
Intranasal oxytocin (Syntocinon; Novartis, Switzerland)
PlaceboDrug
Placebo nasal spray
| Study group | Role | What they receive |
|---|---|---|
| Intranasal Oxytocin | Experimental | Oxytocin nasal spray delivered bi-daily over a 14-day period at 24-IU per dose Receives: 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 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported pain
The Brief Pain Inventory - Short Form
Measured: 14-days
Secondary outcomes (3)
Self-report positive and negative affect
Positive and Negative Affect Scale
Measured: 14-days
Self-report depressed mood, anxious mood, and stress
Depression Anxiety Stress Scale
Measured: 14-day
Self-report sleep
Medical Outcomes Study Sleep Scale
Measured: 14-day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2016 (estimated)
- Study startNov 2016
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tavis S. Campbell, University of Calgary
- Investigators
- Tavis S Campbell, PhD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02888574
- Sponsor's protocol ID
- CHREB16-0334
- Status last verified
- May 2022
- First submitted
- 30 Aug 2016
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 33112417Rash 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.
PubMed 28416501
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Efficacy of Intranasal Oxytocin Among Individuals With Persistent Pain
- ClinicalTrials.gov ID
- NCT02888574
- Acronym / sponsor ID
- CHREB16-0334
- Conditions
- Chronic Pain, Pelvic Pain
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 5 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- Rationale: Oxytocin (OT) is a neuropeptide produced in the supraoptic and paraventricular nuclei of the hypothalamus. There exists at least three plausible mechanisms through which OT may decrease pain sensitivity. In brief, the first mechanism involves spinal signaling. A direct hypothalamo-spinal projection originating from the paraventricular nucleus transports OT, to the dorsal horn (Lamina-I, II, and IV), an area containing OT receptors that influence glutamate and GABA cellular signaling. The second mechanism involves an indirect pathway via the endogenous opioids. Evidence suggests that OT binds to opioid receptors and may also stimulate endogenous opioid release in the brain. Finally, OT may decrease pain by improving mood, decreasing anxiety, and mitigating the stress response. Thirty-three animal investigations have assessed OT-pain relationships with 29 reporting that exogenous administration and higher endogenous levels decreased pain. There is a lack of clarity of an OT-pain association in the human literature due to a paucity of methodologically rigorous trials. Thus far, OT administration has been reported to lower pain sensitivity among patients experiencing chronic back pain, headache, constipation, and colon pain. To date, no research has evaluated the association between intranasal OT and chronic pelvic pain. The association between OT and pain may be different in women with pelvic pain relative to other chronic pain conditions because of a potential peripheral OT-pain pathway. There is an abundance of OT receptors in the uterus, and OT is a potent uterogenic agent that is clinically used in large doses to stimulate uterine contractions and induce labor. While OT does not cross the blood-brain-barrier, the central administration of intranasal OT increases central and blood-plasma OT concentrations. Thus, intranasal OT administration may be associated with pain through central and peripheral pathways; however uterine contractions with 24IU doses of intranasal OT occur in only 1 in every 100-1000 people.
- Research questions and objectives: This research is a pilot study of the efficacy of intranasal OT at improving pain and function among women with chronic pelvic pain of primarily musculoskeletal origin.
- Design: This study will utilize a double-blind, placebo-controlled, within-subjects crossover design. Participants will complete 6-weeks of testing consisting of two 2-week intranasal administrations separated by a 2-week washout period
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intranasal Oxytocin | Experimental | Drug: Intranasal OxytocinOxytocin nasal spray delivered bi-daily over a 14-day period at 24-IU per dose |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intranasal OxytocinAlso: SyntocinonIntranasal oxytocin (Syntocinon; Novartis, Switzerland) | Drug | Intranasal Oxytocin |
| PlaceboPlacebo nasal spray | Drug | Placebo |
Primary outcome
Self-reported pain
Time frame: 14-days
The Brief Pain Inventory - Short Form
3 secondary outcomes
Self-report positive and negative affect
Time frame: 14-days
Self-report depressed mood, anxious mood, and stress
Time frame: 14-day
Self-report sleep
Time frame: 14-day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
- Derived from this study: PubMed 33112417Flynn 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.
- Derived from this study: PubMed 28416501Rash 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tavis S Campbell, PhD principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Intranasal Oxytocin in people with Chronic Pain and Pelvic Pain, run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported pain (time frame: 14-days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02888574, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2022.