Puberty, Sex Hormones and Pain Sensitivity in Adolescents With Migraine

Not Applicable

Recruiting

• Conditions: Migraine
• Interventions: Device: Thermal stimuli; Device: Pressure stimuli; Behavioral: Pain ratings; Behavioral: Pressure pain thresholds (PPT); Behavioral: Conditioned pain modulation (CPM) response; Behavioral: PedMIDAS (Pediatric Migraine Disability Assessment); Diagnostic Test: Hormonal assessment; Other: Pubertal status

• Registration Number: NCT05738213
• Lead Sponsor: Washington University School of Medicine

Brief Summary

The purpose of this research study is to investigate the relationships between sex hormone levels and experimental pain sensitivity and migraine severity will be examined.

Detailed Description

This study will investigate how puberty and variability in sex hormone levels impact pain sensitivity and migraine symptoms.

Hypothesis 1- A significant reduction in pain sensitivity from early to late pubertal status will be found only for adolescents without but not with migraine during pubertal maturation.

Hypothesis 2- Experimental pain sensitivity will be negatively correlated with testosterone levels in adolescents in both groups (with and without migraine).

Exploratory Hypothesis 1- In adolescents with migraine, higher migraine severity (headache frequency and migraine disability) will be associated with lower testosterone levels.

Exploratory hypothesis 2- Adolescents with migraine will have lower testosterone levels than those without.

Study Timeline

• Study First Submitted: 2022-12-06
• Study Start: 2023-01-10
• Study First Submitted QC: 2023-02-20
• Study First Posted: 2023-02-21
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-13
• Last Update Posted: 2025-01-15
• Primary Completion: 2026-01-01
• Study Completion: 2028-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Migraine	Pressure pain thresholds (PPT)	Adolescents with a migraine diagnosis
Migraine	Thermal stimuli	Adolescents with a migraine diagnosis
Migraine	Pressure stimuli	Adolescents with a migraine diagnosis
Healthy control	Pain ratings	Adolescents without a migraine diagnosis
Migraine	Pain ratings	Adolescents with a migraine diagnosis
Migraine	PedMIDAS (Pediatric Migraine Disability Assessment)	Adolescents with a migraine diagnosis
Migraine	Pubertal status	Adolescents with a migraine diagnosis
Healthy control	Thermal stimuli	Adolescents without a migraine diagnosis
Healthy control	Pressure pain thresholds (PPT)	Adolescents without a migraine diagnosis
Healthy control	Hormonal assessment	Adolescents without a migraine diagnosis
Healthy control	Conditioned pain modulation (CPM) response	Adolescents without a migraine diagnosis
Migraine	Conditioned pain modulation (CPM) response	Adolescents with a migraine diagnosis
Migraine	Hormonal assessment	Adolescents with a migraine diagnosis
Healthy control	Pressure stimuli	Adolescents without a migraine diagnosis
Healthy control	Pubertal status	Adolescents without a migraine diagnosis

Primary Outcome Measures

Name	Time	Method
Sex Hormones	Baseline	Testosterone levels
Conditioned pain modulation (CPM) response	Baseline	This psychophysical test examine the inhibitory pain modulation efficiency. In this test, pressure pain thresholds (measures by kilopascal) are assessed before and during immersion of the foot in cold water.

Secondary Outcome Measures

Name	Time	Method
Migraine specific measures	Baseline	Pediatric Migraine Disability Assessment (PedMIDAS) (range 0-540, higher values indicate more disability, with scores \>50 considered as severe disability)
Sex hormone assessments	Baseline	Estrogen levels

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States