Recruiting

Yoga

Sponsor:

Matthew Morris

Code:

NCT03166358

Conditions

Headache

Eligibility Criteria

Sex: All

Age: 13 - 18

Healthy Volunteers: Not accepted

Interventions

Hatha yoga

Study Details

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

Study ID

NCT03166358

Start date

Sep 1, 2015

Status verified date

May, 2017

Completion date

Aug 1, 2018

Anticipated

Primary completion date

Aug 1, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 13 - 18

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: hatha yoga intervention

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

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.

Interventions

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Matthew C Morris, PhD

6153276962mmorris@mmc.edu

Locations

Meharry Medical College

Recruiting

Nashville, Tennessee, United States, 37208

Contacts

Matthew C Morris, PhD

615-327-6962mmorris@mmc.edu

More Information

Sponsor

Matthew Morris

Last update posted

May 25, 2017

Last verified

May, 2017

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Matthew Morris on 2017-05-25.