Adolescent Dysmenorrhoea as a Risk Factor for Chronic Pain: Clinical Cohort Study
ConditionDysmenorrhea
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age11-20
SponsorUniversity of Oxford
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
Current or previous chronic pain condition other than dysmenorrhoea, including migraine.
Pregnant or breast-feeding.
Previous cancer diagnosis.
Contraindication to MRI
Trial population
Participants will be recruited from the community.
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
132 Participants
are grouped into 2 trial groupsGroup A: Dysmenorrhoea
Group B: Controls
Trial outcomes
Primary outcomes
1
Quantitative Sensory Testing (QST)
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.2
Heart rate (HR)
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.3
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).
Time frame
days 1-3 (menstrual phase) and days 10-12 (follicular phase) of the menstrual cycle.4
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.
Time frame
days 1-3 (menstrual phase) and days 10-12 (follicular phase) of the menstrual cycle.Secondary outcomes
1
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).
Time frame
days 1-3 (menstrual phase) and days 10-12 (follicular phase) of the menstrual cycle.2
fMRI scan
fMRI scan with resting sequences, response to punctate stimulation of the abdomen and visual stimulus
Time frame
days 1-3 (menstrual phase) and days 10-12 (follicular phase) of the menstrual cycle.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Oxford
Lead sponsor
University of Exeter
Collaborator
University of York
Collaborator
Endometriosis UK
Collaborator
Source ClinicalTrials.gov