Headache Clinical Trial
Official title:
Yoga for Pediatric Tension-Type Headache
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.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | August 1, 2018 |
Est. primary completion date | August 1, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 13 Years to 18 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Meharry Medical College | Nashville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Matthew Morris |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Headache diary - changes in headache frequency over follow-up | Headache frequency | baseline, 2-week, 4-week, 6-week, post-intervention, 3-month follow-up | |
Primary | Headache diary - changes in headache intensity over follow-up | Headache intensity | baseline, 2-week, 4-week, 6-week, post-intervention, 3-month follow-up | |
Primary | Functional Disability Inventory - changes in pain-related functional disability over follow-up | pain-related functional disability: perceived impact of general and physical health on psychosocial functioning in the last 2 weeks | baseline, 2-week, 4-week, 6-week, post-intervention, 3-month follow-up | |
Primary | Health-Related Quality of Life- Short Form-36: changes in physical functioning over follow-up | health-related quality of life: physical functioning subscale | baseline, 2-week, 4-week, 6-week, post-intervention, 3-month follow-up | |
Primary | Headache Diary - changes in medication use over follow-up | frequency/type of medication used for preventive or abortive purposes | baseline, 2-week, 4-week, 6-week, post-intervention, 3-month follow-up | |
Secondary | changes in temporal summation from pre-intervention to immediately following intervention (8 weeks) | temporal summation to second pain assessed with a TSA-II Neurosensory Analyzer | baseline, post-intervention (8 weeks) [waitlist group will complete an optional third assessment after they finish the yoga classes) | |
Secondary | changes in conditioned pain modulation from pre-intervention to immediately following intervention (8 weeks) | conditioned pain modulation assessed with a TSA-II Neurosensory Analyzer and hot water bath | baseline, post-intervention (8 weeks) [waitlist group will complete an optional third assessment after they finish the yoga classes) | |
Secondary | hair cortisol concentrations - changes in hair cortisol levels from pre-intervention to immediately following intervention (8 weeks) | hair cortisol levels in the previous month will be determined using 1-cm hair samples | baseline, post-intervention (8 weeks) [waitlist group will complete an optional third assessment after they finish the yoga classes) | |
Secondary | changes in cortisol reactivity to experimental pain task from pre-intervention to immediately following intervention (8 weeks) | salivary cortisol will be determined using 5 saliva samples collected during each experimental pain session | baseline, post-intervention (8 weeks) [waitlist group will complete an optional third assessment after they finish the yoga classes) | |
Secondary | changes in alpha-amylase reactivity to experimental pain task from pre-intervention to immediately following intervention (8 weeks) | salivary alpha-amylase will be determined using 5 saliva samples collected during each experimental pain session | baseline, post-intervention (8 weeks) [waitlist group will complete an optional third assessment after they finish the yoga classes) | |
Secondary | changes in DHEA reactivity to experimental pain task from pre-intervention to immediately following intervention (8 weeks) | salivary DHEA will be determined using 5 saliva samples collected during each experimental pain session | baseline, post-intervention (8 weeks) [waitlist group will complete an optional third assessment after they finish the yoga classes) |
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