Dyspareunia and Central Sensitization (NCT03216330) | Clinical Trial Compass
CompletedNot Applicable
Dyspareunia and Central Sensitization
Canada56 participantsStarted 2017-07-19
Plain-language summary
Background: Endometriosis affects 10% of reproductive aged females, and can have a negative impact on sexual quality of life. Endometriosis can cause pelvic pain with deep penetration during intercourse, as well as other sexual and non-sexual pains. This study will allow us to determine if an increase in sexual pain is related to central sensitization.
Purpose: The purpose of this study is to determine if there is an association between the severity of sexual pain and central sensitization in women with endometriosis.
Measurement tools: Data will be collected from the Clinic's Data Registry, an online questionnaire, a quantitative sensory test (QST) to measure pain-pressure threshold (PPT) as a marker of central sensitization, and daily entry to an online survey.
Primary Hypothesis: Central sensitization (measured by lower pain-pressure threshold) will be associated with an increased severity of deep dyspareunia, as well as a tenderness of the bladder/pelvic floor and depression, in women with endometriosis.
Who can participate
Age range
18 Years – 49 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Case:
* Consented to participate in the Data Registry (H16-00264) prior to their physician appointment at the BC Women's Health Centre.
* New or re-referred to the BC Women's Health Centre for Pelvic Pain and Endometriosis.
* Endometriosis (previously surgically diagnosed, or current endometrioma, or current nodule)
* Willing and committed to indicating pain scores and menstrual data on a REDCap survey every day for 6 weeks after the test date.
* At least 18 years old
* Control:
* Reproductive aged female with no suspected or diagnosed endometriosis.
* Have not experienced any sexual pain scores over 4/10 on a 11-point numeric rating scale, as determined on an online questionnaire prior to test day.
* At least 18 years old
Exclusion Criteria:
\- Case and Control:
* Fibromyalgia.
* Severe and enduring psychological illness(es) affecting cognition (e.g., bipolar disorder, schizophrenia etc.).
* Currently pregnant or breastfeeding.
* Have a peripheral or central neurological disorder.
* Have diabetes mellitus or neuropathic pain.
* Do not speak English.
* Have had previous physical trauma (ex. Surgery) to the test site(s) (deltoid muscle in the shoulder, and first dorsal interosseous muscle).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Deep Dyspareunia Score
Timeframe: Case only: daily for 6 weeks after QST testing date