DysmenorrheaRoADPainNCT06353789
Adolescent Dysmenorrhoea as a Risk Factor for Chronic Pain: Clinical Cohort Study
An observational study of Dysmenorrhea, run by University of Oxford at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 11 to 20 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Dysmenorrhea
- How many people
- 132 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Jun 2024to 1 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 11 to 20 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: Participants will be recruited from the community.
Who may be able to join
- 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
Show all 11Show fewer
- 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.
Who cannot join
- Current or previous chronic pain condition other than dysmenorrhoea, including migraine.
- Pregnant or breast-feeding.
- Previous cancer diagnosis.
- Contraindication to MRI
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
University of Oxford
Oxford, Oxfordshire, OX3 9DU
Lydia Coxon, BSc, lydia.coxon@st-hughs.ox.ac.uk, tripp@wrh.ox.ac.uk
Katy Vincent, DPhil, katy.vincent@wrh.ox.ac.uk
About this study
Official title: Understanding the Role of Adolescent Dysmenorrhoea as a Risk Factor for the Transition to Chronic Pain: Clinical Cohort Study
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.
Read the detailed description
Chronic pain is defined as pain that lasts for more than 3 months. It is really common, affecting up to 30% of people worldwide with impacts on all areas of life. Chronic pain is difficult to treat once it has developed. Therefore, understanding which people might be at risk of developing chronic pain and protecting them from it starting, would be a really positive step forward.
It is known that women are more likely to develop almost all types of chronic pain than men. This sex difference in chronic pain starts to be seen after puberty, suggesting that changes happening at this time may be contributing to this increased risk. One important change that happens at this time is periods starting. Despite periods often being very painful, period pain has traditionally been dismissed as "normal" and something girls must learn to live with. However, in adult women with period pain many differences are seen across a range of body systems when compared to women without period pain. These include increased sensitivity to pain; increased sensitivity of the bladder, bowel and womb; altered brain structure and function; and altered responses to stress. Similar changes to those seen with period pain can be seen in other chronic pain conditions. It is not known whether these changes are caused by repeated or continuous pain or if they are part of the reason why chronic pain develops, or a combination of both.
The RoADPain Clinical Study aims to see whether the differences in other body systems described above in adult women with period pain are also seen in girls in the first few years of having periods. The investigators will combine detailed questionnaire data with tests of the function of a variety of systems (including nerve function, stress response and brain imaging). No study treatment or intervention will be given. It is envisaged that 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.
- Conditions
- Dysmenorrhea
- Keywords
- Adolescent, chronic pain
- Medical subject headings
- Dysmenorrhea, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Dysmenorrhoea | Reports period pain ≥4/10 and no other chronic pain | |
| Controls | Reports period pain ≤3/10 and no other chronic pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative Sensory Testing (QST)
QST of the left hand according to the German Neuropathic Pain Network Protocol plus an auditory stimulus.
Measured: days 1-3 (menstrual phase) and days 10-12 (follicular phase) of the menstrual cycle.
Heart rate (HR)
Assessed over a 20 minute period at rest.
Measured: days 1-3 (menstrual phase) and days 10-12 (follicular phase) of the menstrual cycle.
Change in heart rate
Assessed at rest immediately before the CPM paradigm described below and then again immediately after. The ischaemic pain stimulus used as the conditioning stimulus in this paradigm is the most noxious component of the physiological testing paradigms used in this study and therefore the most likely to generate a stress response. The change will be reported as HR(before) - HR(after).
Measured: days 1-3 (menstrual phase) and days 10-12 (follicular phase) of the menstrual cycle.
Bladder sensitivity to filling
Assessed with standardised non-invasive bladder filling paradigm, measured as time to verbal reports of different sensations of bladder fullness (first sensation, first urge) and then need to void (maximum tolerance) after drinking 600 ml water. Subjects will be categorised into those with bladder sensitivity compared to published norms for similar age adolescents and those with normal bladder sensation.
Measured: days 1-3 (menstrual phase) and days 10-12 (follicular phase) of the menstrual cycle.
Volume voided at maximum tolerance
Assessed with standardised non-invasive bladder filling paradigm described in outcome 4. The volume of urine voided when maximum tolerance is reached will be measured in mls.
Measured: days 1-3 (menstrual phase) and days 10-12 (follicular phase) of the menstrual cycle.
Pain Catastrophising: Pain Catastrophising Scale (PCS) (Sullivan)
Measured with the Pain Catastrophising Scale (Sullivan). Scores range from 0 - 52 with high scores representing higher levels of pain catastrophising. Although three sub scales exist they will not be assessed for the purposes of these main analyses.
Measured: days 1-3 (menstrual phase) and days 10-12 (follicular phase) of the menstrual cycle.
Area under the curve (AUC) of single day salivary cortisol profile
Saliva will be collected at home at the specified times allowing a daily AUC of salivary cortisol for each subject to be calculated. Collection times: waking; 30-45 minutes after waking; before lunch; before dinner; bedtime.
Measured: days 1-3 (menstrual phase) and days 10-12 (follicular phase) of the menstrual cycle.
Secondary outcomes (2)
Change of pressure pain threshold (PPT)
A standardised conditioned pain modulation (CPM) paradigm will be used to investigate the change in pressure pain threshold on the dorsum of the foot. An ischaemic stimulus to the contralateral arm will be used as the conditioned stimulus. The foot PPT will be measured before the conditioned stimulus and immediately after. The change will be reported as the (PPTbefore - PPTafter).
Measured: days 1-3 (menstrual phase) and days 10-12 (follicular phase) of the menstrual cycle.
fMRI scan
fMRI scan with resting sequences, response to punctate stimulation of the abdomen and visual stimulus
Measured: days 1-3 (menstrual phase) and days 10-12 (follicular phase) of the menstrual cycle.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study start4 Jun 2024
- Primary completion1 May 2026 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysmenorrheaStudies of the same condition, open and under way.
- More trials run by University of OxfordThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- University of Exeter, University of York, Endometriosis UK
- Responsible party
- Sponsor
- Investigators
- Katy Vincent, MRCOG, DPhil, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06353789
- Sponsor's protocol ID
- RoADPain Clinical Study
- Acronym
- RoADPain
- Status last verified
- Apr 2024
- First submitted
- 2 Apr 2024
- Last updated
- 14 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Once the study and all follow up analyses are complete de-identified data will be deposited in a publically accessible repository as required by the funders.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding the Role of Adolescent Dysmenorrhoea as a Risk Factor for the Transition to Chronic Pain: Clinical Cohort Study
- ClinicalTrials.gov ID
- NCT06353789
- Acronym / sponsor ID
- RoADPain / RoADPain Clinical Study
- Conditions
- Dysmenorrhea
- Keywords
- Adolescent, chronic pain
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- University of Exeter, University of York, Endometriosis UK
- Study start
- 4 Jun 2024 (actual)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 9 Apr 2024 (actual)
- 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 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.
Detailed description
Chronic pain is defined as pain that lasts for more than 3 months. It is really common, affecting up to 30% of people worldwide with impacts on all areas of life. Chronic pain is difficult to treat once it has developed. Therefore, understanding which people might be at risk of developing chronic pain and protecting them from it starting, would be a really positive step forward.
It is known that women are more likely to develop almost all types of chronic pain than men. This sex difference in chronic pain starts to be seen after puberty, suggesting that changes happening at this time may be contributing to this increased risk. One important change that happens at this time is periods starting. Despite periods often being very painful, period pain has traditionally been dismissed as "normal" and something girls must learn to live with. However, in adult women with period pain many differences are seen across a range of body systems when compared to women without period pain. These include increased sensitivity to pain; increased sensitivity of the bladder, bowel and womb; altered brain structure and function; and altered responses to stress. Similar changes to those seen with period pain can be seen in other chronic pain conditions. It is not known whether these changes are caused by repeated or continuous pain or if they are part of the reason why chronic pain develops, or a combination of both.
The RoADPain Clinical Study aims to see whether the differences in other body systems described above in adult women with period pain are also seen in girls in the first few years of having periods. The investigators will combine detailed questionnaire data with tests of the function of a variety of systems (including nerve function, stress response and brain imaging). No study treatment or intervention will be given. It is envisaged that 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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dysmenorrhoea | – | –Reports period pain ≥4/10 and no other chronic pain |
| Controls | – | –Reports period pain ≤3/10 and no other chronic pain |
Who may qualify
- Ages
- 11 to 20 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Participants will be recruited from the community.
Key inclusion criteria (11 listed)
- 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:
Key exclusion criteria (4 listed)
- Current or previous chronic pain condition other than dysmenorrhoea, including migraine.
- Pregnant or breast-feeding.
- Previous cancer diagnosis.
- Contraindication to MRI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Quantitative Sensory Testing (QST)
Time frame: days 1-3 (menstrual phase) and days 10-12 (follicular phase) of the menstrual cycle.
QST of the left hand according to the German Neuropathic Pain Network Protocol plus an auditory stimulus.
Heart rate (HR)
Time frame: days 1-3 (menstrual phase) and days 10-12 (follicular phase) of the menstrual cycle.
Assessed over a 20 minute period at rest.
Change in heart rate
Time frame: days 1-3 (menstrual phase) and days 10-12 (follicular phase) of the menstrual cycle.
Assessed at rest immediately before the CPM paradigm described below and then again immediately after. The ischaemic pain stimulus used as the conditioning stimulus in this paradigm is the most noxious component of the physiological testing paradigms used in this study and therefore the most likely to generate a stress response. The change will be reported as HR(before) - HR(after).
Bladder sensitivity to filling
Time frame: days 1-3 (menstrual phase) and days 10-12 (follicular phase) of the menstrual cycle.
Assessed with standardised non-invasive bladder filling paradigm, measured as time to verbal reports of different sensations of bladder fullness (first sensation, first urge) and then need to void (maximum tolerance) after drinking 600 ml water. Subjects will be categorised into those with bladder sensitivity compared to published norms for similar age adolescents and those with normal bladder sensation.
Volume voided at maximum tolerance
Time frame: days 1-3 (menstrual phase) and days 10-12 (follicular phase) of the menstrual cycle.
Assessed with standardised non-invasive bladder filling paradigm described in outcome 4. The volume of urine voided when maximum tolerance is reached will be measured in mls.
Pain Catastrophising: Pain Catastrophising Scale (PCS) (Sullivan)
Time frame: days 1-3 (menstrual phase) and days 10-12 (follicular phase) of the menstrual cycle.
Measured with the Pain Catastrophising Scale (Sullivan). Scores range from 0 - 52 with high scores representing higher levels of pain catastrophising. Although three sub scales exist they will not be assessed for the purposes of these main analyses.
Area under the curve (AUC) of single day salivary cortisol profile
Time frame: days 1-3 (menstrual phase) and days 10-12 (follicular phase) of the menstrual cycle.
Saliva will be collected at home at the specified times allowing a daily AUC of salivary cortisol for each subject to be calculated. Collection times: waking; 30-45 minutes after waking; before lunch; before dinner; bedtime.
2 secondary outcomes
Change of pressure pain threshold (PPT)
Time frame: days 1-3 (menstrual phase) and days 10-12 (follicular phase) of the menstrual cycle.
fMRI scan
Time frame: days 1-3 (menstrual phase) and days 10-12 (follicular phase) of the menstrual cycle.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2024.
- Individual participant dataSharing planned: Yes. Once the study and all follow up analyses are complete de-identified data will be deposited in a publically accessible repository as required by the funders.
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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.
Katy Vincent, MRCOG, DPhil principal investigator
University of Oxford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dysmenorrhea, run by University of Oxford at 1 site in United Kingdom.
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 11 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 14 Jun 2024. 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 United Kingdom. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Katy Vincent, MRCOG, DPhil (00 44 1865 220024, katy.vincent@wrh.ox.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantitative Sensory Testing (QST) (time frame: days 1-3 (menstrual phase) and days 10-12 (follicular phase) of the menstrual cycle.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jun 2024.