Yoga for Pediatric Tension-Type Headache

NCT03166358 | Unknown

• 1 other identifier: 15-07-410
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Headache

Outcome Measures

Primary Outcomes (5)

• Headache diary - changes in headache frequency over follow-up

  Headache frequency

  baseline, 2-week, 4-week, 6-week, post-intervention, 3-month follow-up

• Headache diary - changes in headache intensity over follow-up

  Headache intensity

  baseline, 2-week, 4-week, 6-week, post-intervention, 3-month follow-up

• 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

• 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

• 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 Outcomes (6)

• changes in temporal summation from pre-intervention to immediately following intervention (8 weeks)

  baseline, post-intervention (8 weeks) [waitlist group will complete an optional third assessment after they finish the yoga classes)

• changes in conditioned pain modulation from pre-intervention to immediately following intervention (8 weeks)

  baseline, post-intervention (8 weeks) [waitlist group will complete an optional third assessment after they finish the yoga classes)

• hair cortisol concentrations - changes in hair cortisol levels from pre-intervention to immediately following intervention (8 weeks)

  baseline, post-intervention (8 weeks) [waitlist group will complete an optional third assessment after they finish the yoga classes)

• changes in cortisol reactivity to experimental pain task from pre-intervention to immediately following intervention (8 weeks)

  baseline, post-intervention (8 weeks) [waitlist group will complete an optional third assessment after they finish the yoga classes)

• changes in alpha-amylase reactivity to experimental pain task from pre-intervention to immediately following intervention (8 weeks)

  baseline, post-intervention (8 weeks) [waitlist group will complete an optional third assessment after they finish the yoga classes)

Study Arms (2)

hatha yoga intervention

EXPERIMENTAL

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

Behavioral: Hatha yoga

waitlist control

NO INTERVENTION

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.

Interventions

Hatha yoga BEHAVIORAL

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 intervention

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Matthew Morris: lead

Study Sites (1)

Meharry Medical College

Nashville, Tennessee, 37208, United States

RECRUITING

MeSH Terms

Conditions

Headache

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Matthew C Morris, PhD

CONTACT

6153276962; mmorris@mmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: Yoga instructor is blind to yoga intervention or waitlist group status of participants.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

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

Study Record Dates

• First Submitted: May 22, 2017
• First Posted: May 25, 2017
• Study Start: September 1, 2015
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: May 25, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)