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

NCT06353789 | Recruiting

• 1 other identifier: RoADPain Clinical Study
• Study Type: observational
• Target: 132
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dysmenorrhea

Keywords

Adolescent; chronic pain

Outcome Measures

Primary Outcomes (7)

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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 Outcomes (2)

• Change of pressure pain threshold (PPT)

  days 1-3 (menstrual phase) and days 10-12 (follicular phase) of the menstrual cycle.

• fMRI scan

  days 1-3 (menstrual phase) and days 10-12 (follicular phase) of the menstrual cycle.

Study Arms (2)

Dysmenorrhoea

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

Controls

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

Eligibility Criteria

• Age: 11 Years - 20 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited from the community.

You may qualify if:

• 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:
• months
• months
• 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.

You may not qualify if:

• Current or previous chronic pain condition other than dysmenorrhoea, including migraine.
• Pregnant or breast-feeding.
• Previous cancer diagnosis.
• Contraindication to MRI

Sponsors & Collaborators

• University of Oxford: lead
• University of Exeter: collaborator
• University of York: collaborator
• Endometriosis UK: collaborator

Study Sites (1)

University of Oxford

Oxford, Oxfordshire, OX3 9DU, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Saliva will be collected and genotyping undertaken

MeSH Terms

Conditions

Dysmenorrhea; Chronic Pain

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Katy Vincent, MRCOG, DPhil

  University of Oxford

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katy Vincent, MRCOG, DPhil

CONTACT

00 44 1865 220024; katy.vincent@wrh.ox.ac.uk

Lydia Coxon, DPhil

CONTACT

00 44 1865 220024; lydia.coxon@wrh.ox.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2024
• First Posted: April 9, 2024
• Study Start: June 4, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: June 14, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available once all analyses are complete.
• Access Criteria: Data will be publically accessible

Locations

GB (1)