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

NCT ID: NCT06353789

Last Updated: 2024-06-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

132 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-04

Study Completion Date

2027-05-01

Brief Summary

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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

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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

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Dysmenorrhea

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Dysmenorrhoea

Reports period pain ≥4/10 and no other chronic pain

No interventions assigned to this group

Controls

Reports period pain ≤3/10 and no other chronic pain

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

11 Years

Maximum Eligible Age

20 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Exeter

OTHER

Sponsor Role collaborator

University of York

OTHER

Sponsor Role collaborator

Endometriosis UK

UNKNOWN

Sponsor Role collaborator

University of Oxford

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Katy Vincent, MRCOG, DPhil

Role: PRINCIPAL_INVESTIGATOR

University of Oxford

Locations

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University of Oxford

Oxford, Oxfordshire, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Katy Vincent, MRCOG, DPhil

Role: CONTACT

00 44 1865 220024

Lydia Coxon, DPhil

Role: CONTACT

00 44 1865 220024

Facility Contacts

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Lydia Coxon, BSc

Role: primary

Katy Vincent, DPhil

Role: backup

Other Identifiers

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RoADPain Clinical Study

Identifier Type: -

Identifier Source: org_study_id

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