Adolescent Dysmenorrhoea as a Risk Factor for Chronic Pain: Clinical Cohort Study

Dysmenorrhea Clinical Trial

— RoADPain  

Official title:

Understanding the Role of Adolescent Dysmenorrhoea as a Risk Factor for the Transition to Chronic Pain: Clinical Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06353789
• Other study ID #: RoADPain Clinical Study
• Status: Recruiting
• Start date: June 4, 2024
• Est. completion date: May 1, 2027

Study information

• Verified date: April 2024
• Source: University of Oxford
• Contact: Katy Vincent, MRCOG, DPhil
• Phone: 00 44 1865 220024
• Email: katy.vincent[@]wrh.ox.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 132
• Est. completion date: May 1, 2027
• Est. primary completion date: May 1, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 11 Years to 20 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Dysmenorrhea

Locations

Country	Name	City	State
United Kingdom	University of Oxford	Oxford	Oxfordshire

Sponsors (4)

Lead Sponsor	Collaborator
University of Oxford	Endometriosis UK, University of Exeter, University of York

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quantitative Sensory Testing (QST)	QST of the left hand according to the German Neuropathic Pain Network Protocol plus an auditory stimulus.	days 1-3 (menstrual phase) and days 10-12 (follicular phase) of the menstrual cycle.
Primary	Heart rate (HR)	Assessed over a 20 minute period at rest.	days 1-3 (menstrual phase) and days 10-12 (follicular phase) of the menstrual cycle.
Primary	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).	days 1-3 (menstrual phase) and days 10-12 (follicular phase) of the menstrual cycle.
Primary	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.	days 1-3 (menstrual phase) and days 10-12 (follicular phase) of the menstrual cycle.
Primary	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.	days 1-3 (menstrual phase) and days 10-12 (follicular phase) of the menstrual cycle.
Primary	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.	days 1-3 (menstrual phase) and days 10-12 (follicular phase) of the menstrual cycle.
Primary	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.	days 1-3 (menstrual phase) and days 10-12 (follicular phase) of the menstrual cycle.
Secondary	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).	days 1-3 (menstrual phase) and days 10-12 (follicular phase) of the menstrual cycle.
Secondary	fMRI scan	fMRI scan with resting sequences, response to punctate stimulation of the abdomen and visual stimulus	days 1-3 (menstrual phase) and days 10-12 (follicular phase) of the menstrual cycle.