Adolescent Dysmenorrhoea as a Risk Factor for Chronic Pain: Clinical Cohort Study (NCT06353789) | Clinical Trial Compass
RecruitingNot Applicable
Adolescent Dysmenorrhoea as a Risk Factor for Chronic Pain: Clinical Cohort Study
United Kingdom132 participantsStarted 2024-06-04
Plain-language summary
This study aims to understand whether changes in a variety of body systems which are seen in adult women with period pain are also seen in adolescents in the first few years of having periods. This information will help to understand 1) how quickly any changes occur, informing clinical practice, and 2) how period pain might lead to other types of chronic pain, potentially allowing development of preventative strategies.
Who can participate
Age range
11 Years – 20 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:
* Participant (or parent/guardian of participant) is willing and able to give informed consent for participation in the study.
* Female or assigned female at birth.
* aged 11 - 20 years.
* At least 6 periods per year since menarche.
* During the study data collection period will be within one of the following time intervals since menarche:
* 12 - 15 months
* 36 - 39 months
* 60 - 63 months
* Reports either period pain or no pain with periods and scores appropriately on NRS (period pain: ≥4/10; no period pain: ≤3/10).
* Not using hormonal therapies (i.e. contraceptives) currently and has not used previously.
* Reasonably fluent in English.
Exclusion Criteria:
* Current or previous chronic pain condition other than dysmenorrhoea, including migraine.
* Pregnant or breast-feeding.
* Previous cancer diagnosis.
* Contraindication to MRI
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
Quantitative Sensory Testing (QST)
Timeframe: days 1-3 (menstrual phase) and days 10-12 (follicular phase) of the menstrual cycle.
2
Heart rate (HR)
Timeframe: days 1-3 (menstrual phase) and days 10-12 (follicular phase) of the menstrual cycle.
3
Change in heart rate
Timeframe: days 1-3 (menstrual phase) and days 10-12 (follicular phase) of the menstrual cycle.
4
Bladder sensitivity to filling
Timeframe: days 1-3 (menstrual phase) and days 10-12 (follicular phase) of the menstrual cycle.
5
Volume voided at maximum tolerance
Timeframe: days 1-3 (menstrual phase) and days 10-12 (follicular phase) of the menstrual cycle.