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Yoga for Pediatric Tension-Type Headache

This study is currently recruiting participants.
Verified May 2017 by Matthew Morris, Meharry Medical College
Sponsor:
ClinicalTrials.gov Identifier:
NCT03166358
First Posted: May 25, 2017
Last Update Posted: May 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Matthew Morris, Meharry Medical College
  Purpose
This study will determine the efficacy of an 8-week Hatha yoga intervention for adolescents with tension-type headache (TTH) and will assess theoretically-driven mediators of treatment response, including experimental pain sensitivity, chronic stress, and negative cognitions linked to chronic pain.

Condition Intervention
Headache Behavioral: Hatha yoga

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Participants are randomized to either a hatha yoga intervention or a waitlist control condition.
Masking: Single (Care Provider)
Masking Description:
Yoga instructor is blind to yoga intervention or waitlist group status of participants.
Primary Purpose: Treatment
Official Title: Yoga for Pediatric Tension-Type Headache

Resource links provided by NLM:


Further study details as provided by Matthew Morris, Meharry Medical College:

Primary Outcome Measures:
  • Headache diary - changes in headache frequency over follow-up [ Time Frame: baseline, 2-week, 4-week, 6-week, post-intervention, 3-month follow-up ]
    Headache frequency

  • Headache diary - changes in headache intensity over follow-up [ Time Frame: baseline, 2-week, 4-week, 6-week, post-intervention, 3-month follow-up ]
    Headache intensity

  • Functional Disability Inventory - changes in pain-related functional disability over follow-up [ Time Frame: baseline, 2-week, 4-week, 6-week, post-intervention, 3-month follow-up ]
    pain-related functional disability: perceived impact of general and physical health on psychosocial functioning in the last 2 weeks

  • Health-Related Quality of Life- Short Form-36: changes in physical functioning over follow-up [ Time Frame: baseline, 2-week, 4-week, 6-week, post-intervention, 3-month follow-up ]
    health-related quality of life: physical functioning subscale

  • Headache Diary - changes in medication use over follow-up [ Time Frame: baseline, 2-week, 4-week, 6-week, post-intervention, 3-month follow-up ]
    frequency/type of medication used for preventive or abortive purposes


Secondary Outcome Measures:
  • changes in temporal summation from pre-intervention to immediately following intervention (8 weeks) [ Time Frame: baseline, post-intervention (8 weeks) [waitlist group will complete an optional third assessment after they finish the yoga classes) ]
    temporal summation to second pain assessed with a TSA-II Neurosensory Analyzer

  • changes in conditioned pain modulation from pre-intervention to immediately following intervention (8 weeks) [ Time Frame: baseline, post-intervention (8 weeks) [waitlist group will complete an optional third assessment after they finish the yoga classes) ]
    conditioned pain modulation assessed with a TSA-II Neurosensory Analyzer and hot water bath

  • hair cortisol concentrations - changes in hair cortisol levels from pre-intervention to immediately following intervention (8 weeks) [ Time Frame: baseline, post-intervention (8 weeks) [waitlist group will complete an optional third assessment after they finish the yoga classes) ]
    hair cortisol levels in the previous month will be determined using 1-cm hair samples

  • changes in cortisol reactivity to experimental pain task from pre-intervention to immediately following intervention (8 weeks) [ Time Frame: baseline, post-intervention (8 weeks) [waitlist group will complete an optional third assessment after they finish the yoga classes) ]
    salivary cortisol will be determined using 5 saliva samples collected during each experimental pain session

  • changes in alpha-amylase reactivity to experimental pain task from pre-intervention to immediately following intervention (8 weeks) [ Time Frame: baseline, post-intervention (8 weeks) [waitlist group will complete an optional third assessment after they finish the yoga classes) ]
    salivary alpha-amylase will be determined using 5 saliva samples collected during each experimental pain session

  • changes in DHEA reactivity to experimental pain task from pre-intervention to immediately following intervention (8 weeks) [ Time Frame: baseline, post-intervention (8 weeks) [waitlist group will complete an optional third assessment after they finish the yoga classes) ]
    salivary DHEA will be determined using 5 saliva samples collected during each experimental pain session


Estimated Enrollment: 40
Actual Study Start Date: September 1, 2015
Estimated Study Completion Date: August 1, 2018
Estimated Primary Completion Date: August 1, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: hatha yoga intervention
Participants randomized to the intervention are asked to attend 8 hatha yoga classes delivered in a group format.
Behavioral: Hatha yoga
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.
No Intervention: waitlist control
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.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   13 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Eligible participants will have a diagnosis of TTH with or without migraines according to the International Classification for Headache Disorders criteria, be between 13 and 18 years old (inclusive), English-speaking, and willing to be randomized and attend yoga sessions regularly.

Exclusion Criteria:

  • Participants will be excluded if they have any injury, disease, or metabolic dysfunction known to influence pain, have any physical limitations deemed by a medical practitioner to preclude yoga practice, had attended yoga classes in the previous 3 months, are currently pregnant, or have a history of drug or alcohol dependence within 6 months of screening.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03166358


Contacts
Contact: Matthew C Morris, PhD 6153276962 mmorris@mmc.edu

Locations
United States, Tennessee
Meharry Medical College Recruiting
Nashville, Tennessee, United States, 37208
Contact: Matthew C Morris, PhD    615-327-6962    mmorris@mmc.edu   
Sponsors and Collaborators
Matthew Morris
  More Information

Responsible Party: Matthew Morris, Associate Professor, Meharry Medical College
ClinicalTrials.gov Identifier: NCT03166358     History of Changes
Other Study ID Numbers: 15-07-410
First Submitted: May 22, 2017
First Posted: May 25, 2017
Last Update Posted: May 25, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual participant data will not be made available to other researchers.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Headache
Tension-Type Headache
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases