Study: NCT05738213

Intervention type: BEHAVIORAL
Group type: PLACEBO_COMPARATOR
Intervention: Pain ratings
Description: Pain intensity and pain unpleasantness ratings will be assessed.

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Pain ratings
Description: Pain intensity and pain unpleasantness ratings will be assessed.

Intervention type: BEHAVIORAL
Group type: PLACEBO_COMPARATOR
Intervention: Pressure pain thresholds (PPT)
Description: Pressure will be increased continually and participants will be instructed to press a button the first moment they feel pain from the pressure stimulus. The first threshold measurement will be used as a familiarization. The average threshold is calculated from three measurements.

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Pressure pain thresholds (PPT)
Description: Pressure will be increased continually and participants will be instructed to press a button the first moment they feel pain from the pressure stimulus. The first threshold measurement will be used as a familiarization. The average threshold is calculated from three measurements.

Intervention type: BEHAVIORAL
Group type: PLACEBO_COMPARATOR
Intervention: Conditioned pain modulation (CPM) response
Description: The CPM paradigm assesses endogenous inhibitory pain modulation efficiency. CPM testing includes the application of a test stimulus without conditioning (control run, pressure pain thresholds) and a subsequent application of the same test stimulus together with a conditioning stimulus (conditioning run, a 60 second of foot immersion in cold water). The CPM response is the difference in the pressure pain thresholds between the control and the conditioning runs.

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Conditioned pain modulation (CPM) response
Description: The CPM paradigm assesses endogenous inhibitory pain modulation efficiency. CPM testing includes the application of a test stimulus without conditioning (control run, pressure pain thresholds) and a subsequent application of the same test stimulus together with a conditioning stimulus (conditioning run, a 60 second of foot immersion in cold water). The CPM response is the difference in the pressure pain thresholds between the control and the conditioning runs.

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: PedMIDAS (Pediatric Migraine Disability Assessment)
Description: Adolescents with migraine will complete questions regarding their headache frequency. Migraine disability will be assessed using PedMIDAS (Pediatric Migraine Disability Assessment). This self-reported questionnaire assesses the number of days that headaches affect participant's daily activities. This is a widely used, reliable and validated tool to assess migraine disability.

Intervention type: DIAGNOSTIC_TEST
Group type: PLACEBO_COMPARATOR
Intervention: Hormonal assessment
Description: Blood samples (approximetly 2 tablespoons) will be collected for analyses of sex hormone levels (e.g., testosterone, estradiol, progesterone).

Intervention type: DIAGNOSTIC_TEST
Group type: ACTIVE_COMPARATOR
Intervention: Hormonal assessment
Description: Blood samples (approximetly 2 tablespoons) will be collected for analyses of sex hormone levels (e.g., testosterone, estradiol, progesterone).

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Pubertal status
Description: Pubertal status will be assessed using the self-reported Physical Developmental Scale-Wave 3 survey, which allows for differentiation between pre-, early-, late-, and post-pubertal status. Early puberty is defined as a score of 3 and no menarche, mid-puberty is defined as 4 and no menarche, late pubertal is defined as a score of 7 points or less and with menarche, and post pubertal is defined as a score of 8 and menarche. For boys, pubertal maturation status will be determined by the Physical Development Scale using the body hair growth voice change and facial hair questions. Early puberty is defined as a score of 4-5, mid-puberty is defined as a score of 6-8, late pubertal is defined as a score of 9-11 points, and post pubertal is defined as a score of 12.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Pubertal status
Description: Pubertal status will be assessed using the self-reported Physical Developmental Scale-Wave 3 survey, which allows for differentiation between pre-, early-, late-, and post-pubertal status. Early puberty is defined as a score of 3 and no menarche, mid-puberty is defined as 4 and no menarche, late pubertal is defined as a score of 7 points or less and with menarche, and post pubertal is defined as a score of 8 and menarche. For boys, pubertal maturation status will be determined by the Physical Development Scale using the body hair growth voice change and facial hair questions. Early puberty is defined as a score of 4-5, mid-puberty is defined as a score of 6-8, late pubertal is defined as a score of 9-11 points, and post pubertal is defined as a score of 12.