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Yoga Training for Returning Veterans With Headache

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by University of California, Los Angeles
Sponsor:
Information provided by (Responsible Party):
Bruce Naliboff, PhD, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01993069
First received: July 16, 2013
Last updated: November 22, 2013
Last verified: November 2013
  Purpose

The objective of the study is to evaluate the efficacy of a yoga treatment for veterans with mild post-traumatic and chronic tension-type headaches.

Study Aims:

  • Does this yoga treatment, targeted toward specific symptoms veterans with mild post-traumatic and chronic tension-type headaches experience, assist in decreasing headaches and associated symptoms?
  • Does this yoga treatment, targeted toward specific symptoms veterans with mild post-traumatic and chronic tensions-type headaches experience, assist in improving quality of life?
  • Does this yoga treatment, targeted toward specific symptoms veterans with mild post-traumatic and chronic tension-type headaches experience, improve mood?
  • Do the effects of yoga on symptoms, mood, and quality of life maintain 2 months post completion of treatment?

Condition Intervention
Post Traumatic Headache
Chronic Daily Headache
Behavioral: Iyengar-based Yoga Training

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Yoga Training for Returning Veterans With Headache

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Symptom relief, headache [ Time Frame: Post-Treatment, up to 2 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: October 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Iyengar-based Yoga Training
6 weekly Iyengar-based yoga classes
Behavioral: Iyengar-based Yoga Training
6 weekly Iyengar-based yoga classes

Detailed Description:

The objective of the study is to evaluate the efficacy of a yoga treatment for veterans with mild post-traumatic and chronic tension-type headaches. The yoga will be provided in the form of 6 weekly yoga sessions aimed at providing direct instruction and immediate feedback on postures, breathing, and relaxation techniques in a small group format. The sessions will be led by an experienced yoga instructor who is a part of the study team and have worked with medical patients. A post-yoga 2-month follow-up assessment of self-reported symptoms, mood, and quality of life will also be assessed.

This is a feasibility study to determine if a yoga treatment is received favorably and can be successfully delivered to veterans seeking treatments for post-traumatic and chronic tension-type headaches. This study does not include a comparison group; therefore, we can only make conclusions based on pre to post differences in subjects who participate in the yoga. Our aim for this study is to collect data on the potential benefits of a targeted yoga treatment for symptoms experienced by these subjects, and to then utilize these data to implement a larger study with a comparison group.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Eligibility determined at screening will be based on the following inclusion criteria: Mild post traumatic headaches or chronic tension-type headaches, diagnosed by a physician. Inclusion criteria also includes the following: 1). Ability to participate in yoga classes (i.e., no physical limitations, mobility issues, or severe chronic medical issues/symptoms such as severe chronic back pain or injury, amputees, being wheelchair bound), 2). Not current involved in regular yoga of more than an hour of yoga per week in a formal setting, 3). If a woman, not currently pregnant or breast feeding, 4). Ages 18 and up (no maximal age limit), 5). Veterans only (no non-veteran populations), and 6). Not currently suffering from severe psychiatric diagnoses (e.g., schizophrenia, bipolar disorder), a history of psychiatric hospitalization, or current substance abuse or dependence.

Exclusion Criteria:

Exclusion based on the following: 1). Age less than 18 years old (not an adult); 2). Not a veteran; 3). Physical limitations, mobility issues, or severe chronic medical issues that may impede one's ability to participate in yoga classes (e.g., wheelchair bound veterans, amputees, those with severe musculoskeletal or nerve pain or injury such as chronic back pain with significantly limited range of motion); 4). Current severe psychiatric diagnoses (e.g., schizophrenia, bipolar disorder) or history of psychiatric hospitalizations; 5). Current substance abuse or dependence; 6). Current regular yoga practice involving more than an hour of yoga per week in a formal setting; and 7). If a woman, currently pregnant or breast feeding.

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01993069

Contacts
Contact: Milena Zirovich, MD 310-478-3711 ext 42487 milena.zirovich@va.gov

Locations
United States, California
VA Greater Los Angeles Healthcare System Recruiting
Los Angeles, California, United States, 90073
Contact: Milena Zirovich, MD    310-478-3711 ext 42487    milena.zirovich@va.gov   
Sponsors and Collaborators
University of California, Los Angeles
Investigators
Principal Investigator: Bruce Naliboff, PhD University of California, Los Angeles
Principal Investigator: Milena Zirovich, MD VAGLAHS
  More Information

No publications provided

Responsible Party: Bruce Naliboff, PhD, Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01993069     History of Changes
Other Study ID Numbers: PCC 2013-020286
Study First Received: July 16, 2013
Last Updated: November 22, 2013
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Headache
Headache Disorders
Post-Traumatic Headache
Brain Diseases
Central Nervous System Diseases
Headache Disorders, Secondary
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on November 20, 2014