Post Traumatic HeadacheNCT01993069
Yoga Training for Returning Veterans With Headache
A study testing Iyengar-based Yoga Training in people with Post Traumatic Headache and Chronic Daily Headache, run by University of California, Los Angeles at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Traumatic Headache, Chronic Daily Headache
- What is being tested?
- Iyengar-based Yoga Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Greater Los Angeles Healthcare System
Los Angeles, California, 90073
About this study
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?
Read the 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.
- Conditions
- Post Traumatic Headache, Chronic Daily Headache
- Being tested
- Iyengar-based Yoga Training
- Medical subject headings
- Post-Traumatic Headache, Headache Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iyengar-based Yoga TrainingBehavioural
6 weekly Iyengar-based yoga classes
| Study group | Role | What they receive |
|---|---|---|
| Iyengar-based Yoga Training | Experimental | 6 weekly Iyengar-based yoga classes Receives: Behavioral: Iyengar-based Yoga Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom relief, headache
Measured: Post-Treatment, up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startOct 2013
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Traumatic HeadacheStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bruce Naliboff, PhD, University of California, Los Angeles
- Investigators
- Bruce Naliboff, PhD, Principal investigator, University of California, Los AngelesMilena Zirovich, MD, Principal investigator, VAGLAHS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01993069
- Sponsor's protocol ID
- PCC 2013-020286
- Status last verified
- May 2017
- First submitted
- 16 Jul 2013
- Last updated
- 2 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Yoga Training for Returning Veterans With Headache
- ClinicalTrials.gov ID
- NCT01993069
- Acronym / sponsor ID
- PCC 2013-020286
- Conditions
- Post Traumatic Headache, Chronic Daily Headache
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 25 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Iyengar-based Yoga Training | Experimental | Behavioral: Iyengar-based Yoga Training6 weekly Iyengar-based yoga classes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iyengar-based Yoga Training6 weekly Iyengar-based yoga classes | Behavioural | Iyengar-based Yoga Training |
Primary outcome
Symptom relief, headache
Time frame: Post-Treatment, up to 2 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruce Naliboff, PhD principal investigator
University of California, Los Angeles
Milena Zirovich, MD principal investigator
VAGLAHS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Iyengar-based Yoga Training in people with Post Traumatic Headache and Chronic Daily Headache, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom relief, headache (time frame: Post-Treatment, up to 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2017.