University of Oxford
Oxford, Oxfordshire, OX3 9DU, United Kingdom
Location status: Recruiting
Location contact
Katy Vincent, DPhil
CONTACT
Lydia Coxon, BSc
CONTACT
NCT Number: NCT06353789
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.
Interested in participating?
Request Info11 year–20 year
Female
Observational
Oxford, Oxfordshire, OX3 9DU, United Kingdom
Location status: Recruiting
Katy Vincent, DPhil
CONTACT
Lydia Coxon, BSc
CONTACT
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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).
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.
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.
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.
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.
Time frame: days 1-3 (menstrual phase) and days 10-12 (follicular phase) of the menstrual cycle.
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).
Time frame: days 1-3 (menstrual phase) and days 10-12 (follicular phase) of the menstrual cycle.
fMRI scan with resting sequences, response to punctate stimulation of the abdomen and visual stimulus
Contact information is provided by the study sponsor or research team.
Katy Vincent, MRCOG, DPhil
CONTACT
Lydia Coxon, DPhil
CONTACT
University of Oxford
Other
Understanding the Role of Adolescent Dysmenorrhoea as a Risk Factor for the Transition to Chronic Pain: Clinical Cohort Study
Acronym: RoADPain
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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