Participants randomized to the intervention are asked to attend 8 hatha yoga classes delivered in a group format.

Participants randomized to the waitlist control condition complete assessments while the intervention group completes the yoga intervention. They are given the option to complete 8 hatha yoga classes delivered in group format once the waitlist period is finished.

Headache

8 Hatha yoga classes lasting approximately one hour each and delivered in small group format (i.e., classes no larger than 8 participants). Classes are tailored to address pediatric tension-type headache.

Hatha yoga

Meharry Medical College

Yoga for Pediatric Tension-Type Headache

pain-related functional disability: perceived impact of general and physical health on psychosocial functioning in the last 2 weeks

health-related quality of life: physical functioning subscale

frequency/type of medication used for preventive or abortive purposes

temporal summation to second pain assessed with a TSA-II Neurosensory Analyzer

conditioned pain modulation assessed with a TSA-II Neurosensory Analyzer and hot water bath

hair cortisol levels in the previous month will be determined using 1-cm hair samples

salivary cortisol will be determined using 5 saliva samples collected during each experimental pain session

salivary alpha-amylase will be determined using 5 saliva samples collected during each experimental pain session

salivary DHEA will be determined using 5 saliva samples collected during each experimental pain session

Individual participant data will not be made available to other researchers.

Matthew Morris

Associate Professor

Participants are randomized to either a hatha yoga intervention or a waitlist control condition.

Yoga instructor is blind to yoga intervention or waitlist group status of participants.

Aerobe bicycle ergometer training within 77-95% of maximum oxygen consumption; duration of each training session: 20 minutes; frequency of training: 6 sessions within 12 days

Aerobe training below 70% of maximum oxygen consumption (including light stretching and simple exercises adapted from yoga figures); duration of training session: 20 minutes; frequency of training: 6 sessions within 12 days

Generalized Anxiety Disorder (GAD)

high-intensive aerobe exercise

low-intensive aerobe exercise

Department of Psychiatry and Psychotherapy, Charité - Universitätsmedizin Berlin, Campus Mitte

Clinical, Neurophysiological and Neuroendocrine Effects of Aerobe Exercise in Generalized Anxiety Disorder (GAD)

PSWQ is a questionnaire for detecting the severity of GAD

SOMS is a questionnaire for detecting the severity of somatisation

PSWQ-PW is a questionnaire for detecting changes in GAD-severity

SOMS-7T is a questionnaire for detecting changes in somatisation

HAM-A is a questionnaire for detecting the severity and changes of anxiety

ACQ is a questionnaire for evaluating the ability to control anxiety

Cortisol is an established marker of the psychophysiological stress response

Alpha amylase is an established marker of the psychophysiological stress response

Mismatch negativity is an established correlate of the central information processing

Loudness dependence auditory evoked potentials are established correlates of the central serotonergic transmission

Dr. Jens Plag

physician

Charite University, Berlin, Germany

Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.
All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.

Subjects randomized to Group B will be provided with 1 tablet of placebo to be taken at onset of menstrual migraine headache pain.
All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.

Subjects randomized to Group B will be provided with 1 tablet of placebo to be taken at onset of menstrual migraine headache pain.
All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.
Placebo : A placebo tablet matching Treximet for oral administration.

Placebo

Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.
All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.
Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg.

Treximet

Total

Sex: Female, Male

Region of Enrollment

Number of subjects either pain free or mild at 2 hours then pain level increases within 24 hours following treatment with Treximet versus (vs.) Placebo for 1 menstrual migraine.
0-3 pain scale with 0=No Pain, 1=Mild, 2=Moderate,and 3=Severe.

Migraine Recurrence

Duration of 1 menstrual migraine from time of treatment at menstrual migraine headache onset until pain free in Treximet vs. Placebo arms.
0-3 pain scale with 0=No Pain, 1=Mild, 2=Moderate, and 3=Severe.

Time to Pain Free

Vasoactive Intestinal Peptide (VIP), Prostaglandin E2 (PGE2), Cortisol, Prostaglandin I2 (PGI2), Estradiol, and β-endorphin** levels collected at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment in Treximet vs. Placebo arms for 1 menstrual migraine headache * This endpoint was separated into 3 outcome measures as all biomarkers were not reported in the same units of measure. Calcitonin Gene-Related Peptide (CGRP) and α-amylase both have their own outcome measure reported individually.
**β-endorphin levels were not assayed due to limitations on saliva sample volumes.

Biomarkers Measured at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment

CGRP levels collected at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment in Treximet vs. Placebo arms for 1 menstrual migraine headache
* This endpoint was separated into 3 outcome measures as all biomarkers were not reported in the same units of measure.

CGRP Measured at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment

α-Amylase levels collected at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment in Treximet vs. Placebo arm for 1 menstrual migraine headache
* This endpoint was separated into 3 outcome measures as all biomarkers were not reported in the same units of measure.

α-Amylase Measured at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment

Number of subjects either pain-free or mild at 2 hours then pain level increases within 24 hours following treatment in Treximet vs. Placebo arm for 1 menstrual migraine headache with Treximet vs. Placebo in responders* vs. non-responders.
0-3 Pain Scale with 0=No Pain, 1=Mild, 2=Moderate, and 3=Severe
*A responder is defined as those who at the time of two hours post treatment reported mild or no pain. Additionally, these subjects could not have taken a rescue medication or have a pain level increase within 24 hours post treatment.
A non-responder is one that fails to meet the responder criteria.

Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.
All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.
Responders were defined as subjects who had a headache with a severity of 0=No Pain or 1=Mild Pain at two hours post treatment, and subjects could not have rescued with additional medication, and their headache could not have returned within 24 hours.
Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg.

Treximet Responder

Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.
All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.
Non-Responders were defined as subjects who had a headache with a severity of 3=Severe Pain or 2=Moderate Pain at two hours post treatment, and/or subjects that rescued with additional medication, and/or their headache increased and/or returned within 24 hours.
Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg.

Treximet Non-Responder

Migraine Recurrence Responders vs Non-Responders

Duration of time from treatment at menstrual migraine headache onset until pain-free in Treximet vs. Placebo arms in responders* vs. non-responders for 1 menstrual migraine.
0-3 Pain Scale, with 0=No Pain, 1=Mild, 2=Moderate, and 3=Severe.
*A responder is defined as those who at the time of two hours post treatment reported mild or no pain. Additionally, these subjects could not have taken a rescue medication or have a pain level increase within 24 hours post treatment.
A non-responder is one that fails to meet the responder criteria.

Time to Pain-Free in Responders vs Non-Responders

VIP, PGE2, Cortisol, PGI2, Estradiol, and β-endorphin** levels collected for 1 menstrual migraine headache at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment in Treximet vs. Placebo arms in responders vs. non-responders***.
*This endpoint was separated into 3 outcome measures as all biomarkers were not reported in the same unit of measure. CGRP and α-amylase both have their own outcome measure reported individually.
**β-endorphin levels were not assayed due to limitations on saliva sample volumes.
***A responder is defined as those who at the time of two hours post treatment reported mild or no pain. Additionally, these subjects could not have taken a rescue medication or have a pain level increase within 24 hours post treatment.
A non-responder is one that fails to meet the responder criteria.

Biomarkers Measured at Baseline, Menstrual Migraine Onset, and 2 Hours Post Treatment in Responders vs Non-Responders

CGRP levels collected for 1 menstrual migraine headache at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post-Treatment in Responders vs Non-Responders**.
*This endpoint was separated into 3 outcome measures as all biomarkers were not reported in the same units of measure.
**A responder is defined as those who at the time of two hours post treatment reported mild or no pain. Additionally, these subjects could not have taken a rescue medication or have a pain level increase within 24 hours post treatment.
A non-responder is one that fails to meet the responder criteria.

CGRP Measured at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post-Treatment in Responders vs Non-Responders

α-Amylase levels collected at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment in Responders vs Non-Responders*.
*A responder is defined as those who at the time of two hours post treatment reported mild or no pain. Additionally, these subjects could not have taken a rescue medication or have a pain level increase within 24 hours post treatment.
A non-responder is one that fails to meet the responder criteria.

α-Amylase Measured at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment in Responders vs Non-Responders

VIP, PGE2, Cortisol, PGI2, Estradiol, and β-endorphin** levels collected at Menstrual Migraine Headache Onset, Migraine Headache Free and 24 Hours Migraine Headache Free in Treximet vs. Placebo arm for 1 menstrual migraine headache.
* This endpoint was separated into 3 outcome measures as all biomarkers were not reported in the same units of measure. CGRP and α-amylase both have their own outcome measure reported individually.
**β-endorphin levels were not assayed due to limitations on saliva sample volumes.

Biomarkers Measured at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free.

CGRP levels collected at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free in Treximet vs. Placebo arm for 1 menstrual migraine headache.
* This endpoint was separated into 3 outcome measures as all biomarkers were not reported in the same units of measure.

CGRP Measured at Menstrual Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free.

α-Amylase levels collected at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free in Treximet vs. Placebo arm for 1 menstrual migraine headache
* This endpoint was separated into 3 outcome measures as all biomarkers were not reported in the same units of measure.

α-Amylase Measured at Menstrual Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free.

Correlation of mean estrogen levels in saliva and urine estradiol at mid luteal, menstrual migraine headache onset*, and at migraine headache free following treatment with Treximet vs. Placebo for 1 menstrual migraine headache
*Urine estradiol levels were not collected at migraine onset, therefore; correlations could not be completed for that time point.

Correlation of Mean Estrogen Levels in Saliva and Urine Estradiol at Mid Luteal and at Menstrual Migraine Headache Free.

VIP, PGE2, Cortisol, PGI2, Estradiol, and β-endorphin** levels collected for 1 menstrual migraine headache at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free in Responders vs Non-Responders***.
*This endpoint was separated into 3 outcome measures as all biomarkers were not reported in the same units of measure. CGRP and α-amylase both have their own outcome measure reported individually.
**β-endorphin levels were not assayed due to limitations on saliva sample volumes.
***A responder is defined as those who at the time of two hours post treatment reported mild or no pain. Additionally, these subjects could not have taken a rescue medication or have a pain level increase within 24 hours post treatment. A non-responder is one that fails to meet the responder criteria.

Biomarkers Measured at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free in Responders vs Non-Responders

CGRP levels collected for 1 menstrual migraine headache at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free in Responders vs Non-Responders**.
*This endpoint was separated into 3 outcome measures as all biomarkers were not reported in the same units of measure.
**A responder is defined as those who at the time of two hours post treatment reported mild or no pain. Additionally, these subjects could not have taken a rescue medication or have a pain level increase within 24 hours post treatment.
A non-responder is one that fails to meet the responder criteria.

CGRP Measured at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free in Responders vs Non-Responders

α-Amylase levels collected for 1 menstrual migraine at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free in Responders vs Non-Responders**.
*This endpoint was separated into 3 outcome measures as all biomarkers were not reported in the same units of measure.
**A responder is defined as those who at the time of two hours post treatment reported mild or no pain. Additionally, these subjects could not have taken a rescue medication or have a pain level increase within 24 hours post treatment.
A non-responder is one that fails to meet the responder criteria.

α-Amylase Measured at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free in Responders vs Non-Responders

Correlation of mean estrogen levels in saliva and urine estradiol at mid-luteal, menstrual migraine headache onset* and at migraine headache free following treatment in responders vs. non-responders**.
*Urine estradiol levels were not collected at migraine onset, therefore; correlations could not be completed for that time point.
***A responder is defined as those who at the time of two hours post treatment reported mild or no pain. Additionally, these subjects could not have taken a rescue medication or have a pain level increase within 24 hours post treatment.
A non-responder is one that fails to meet the responder criteria.

Correlation of Mean Estrogen Levels in Saliva and Urine Estradiol at Mid-Luteal and at Menstrual Migraine Headache Free in Responders vs Non-Responders

Overall Study

Dr. Roger Cady

Menstrual Migraine

Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg.

A placebo tablet matching Treximet for oral administration.

Clinvest

University Internal Medicine Associates, Inc.

CGRP, Estrogen, Cortisol, VIP, α-Amylase, PGE2, PGI2 and ß-Endorphin Levels in Menstrual Migraine Before and After Treximet

Evaluation of CGRP, Estrogen, Cortisol, VIP, α-Amylase, PGE2, PGI2 and ß-Endorphin Levels in Saliva of Menstrual Migraine Patients Before and After Treatment With Treximet™

alpha amylase/päänsärky

Yoga for Pediatric Tension-Type Headache

Clinical, Neurophysiological and Neuroendocrine Effects of Aerobe Exercise in Generalized Anxiety Disorder (GAD)

CGRP, Estrogen, Cortisol, VIP, α-Amylase, PGE2, PGI2 and ß-Endorphin Levels in Menstrual Migraine Before and After Treximet

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