Episodic Tension Type HeadachePhase 2NCT01488825
Yoga Intervention Study on Episodic Tension Type Headache
A Phase 2 study testing Yoga Therapy in people with Episodic Tension Type Headache, run by NMP Medical Research Institute at 1 site in India.
Trial summary
The present study was designed to evaluate effect of yoga intervention on patients having frequent tension type headache. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Episodic Tension Type Headache
- What is being tested?
- Yoga Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteIndia
- Study dates
- Jan 2005to Jun 2006
- Phase
- Phase 2
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- aged between 18 to 60 years
- more than 5 but fewer than 15 headache episodes per month
- headache intensity moderate to severe
Who cannot join
- Patients on anti-psychotic, antidepressant or any prophylactic medication
- pregnancy
- Taking psychotherapy or any other alternative medicine
- migraine headache more than 1 day a month
- pain disorder, psychiatric or medical disorder requiring immediate treatment,
- headache due to sinusitis, eyestrain, cervical spondylosis and posttraumatic headaches
Trial locations and contacts
1 site in 1 country.
India1 site
Pain Clinic, NMP Medical Research Institute
Jaipur, Rajasthan, 302019
About this study
Official title: Effect of Yoga Intervention on Episodic Tension Type Headache: A Randomized Controlled Trial
The present study was designed to evaluate effect of yoga intervention on patients having frequent tension type headache.
- Conditions
- Episodic Tension Type Headache
- Being tested
- Yoga Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yoga TherapyBehavioural
Therapeutically oriented style of yoga originated from Pancha Kosha philosophy of Vedanta was used throughout the trial. All the sessions emphasized on postures, breathing practices with the specific focus on relaxation, combination of chants and meditation. Once a week, Kunjal and Jalaneti (cleansing practices) were practiced in guidance of therapist. They all were instructed to eat light and rest on Kriya days.
| Study group | Role | What they receive |
|---|---|---|
| Wait-list control group | No intervention | The wait-list control group received no intervention, or instruction and they were observed with their usual care for 12-weeks intervention period. Upon completion of the study, this group received 12 weeks of yoga intervention. |
| Yoga Intervention Group | Experimental | The yoga sessions developed specifically for study participant consisted of 12 weekly 60-minute designed to benefit in episodic tension type headache. Receives: Behavioral: Yoga Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of headache
Measured: 3 Months
Secondary outcomes (6)
Duration of Headache
Measured: 3 months
Severity of headache
Measured: 3 Months
Analgesic consumption
Measured: 3 Months
Anxiety levels
Measured: 3 months
Depression
Measured: 3 months
Stress
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2011 (estimated)
- Study startJan 2005
- Primary completionFeb 2006
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Episodic Tension Type HeadacheStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- NMP Medical Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Neha SHARMA, PhD, Principal investigator, NMP Medical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01488825
- Sponsor's protocol ID
- NMP-0090-YR
- Status last verified
- Dec 2011
- First submitted
- 6 Dec 2011
- Last updated
- 8 Dec 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Yoga Intervention on Episodic Tension Type Headache: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01488825
- Acronym / sponsor ID
- NMP-0090-YR
- Conditions
- Episodic Tension Type Headache
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- NMP Medical Research InstituteUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- Feb 2006 (actual)
- Study completion
- Jun 2006 (actual)
- First posted
- 8 Dec 2011 (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 present study was designed to evaluate effect of yoga intervention on patients having frequent tension type headache.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wait-list control group | No intervention | –The wait-list control group received no intervention, or instruction and they were observed with their usual care for 12-weeks intervention period. Upon completion of the study, this group received 12 weeks of yoga intervention. |
| Yoga Intervention Group | Experimental | Behavioral: Yoga TherapyThe yoga sessions developed specifically for study participant consisted of 12 weekly 60-minute designed to benefit in episodic tension type headache. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- aged between 18 to 60 years
- more than 5 but fewer than 15 headache episodes per month
- headache intensity moderate to severe
Key exclusion criteria (6 listed)
- Patients on anti-psychotic, antidepressant or any prophylactic medication
- pregnancy
- Taking psychotherapy or any other alternative medicine
- migraine headache more than 1 day a month
- pain disorder, psychiatric or medical disorder requiring immediate treatment,
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 |
|---|---|---|
| Yoga TherapyTherapeutically oriented style of yoga originated from Pancha Kosha philosophy of Vedanta was used throughout the trial. All the sessions emphasized on postures, breathing practices with the specific focus on relaxation, combination of chants and meditation. Once a week, Kunjal and Jalaneti (cleansing practices) were practiced in guidance of therapist. They all were instructed to eat light and rest on Kriya days. | Behavioural | Yoga Intervention Group |
Primary outcome
Frequency of headache
Time frame: 3 Months
6 secondary outcomes
Duration of Headache
Time frame: 3 months
Severity of headache
Time frame: 3 Months
Analgesic consumption
Time frame: 3 Months
Anxiety levels
Time frame: 3 months
Depression
Time frame: 3 months
Stress
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2011.
Related trials for Episodic Tension Type Headache
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Recruiting
Pilot Study of the Osteo-Fluidic-Sensitive (OFS) in Tension-type Headache.
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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.
Neha SHARMA, PhD principal investigator
NMP Medical Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Yoga Therapy in people with Episodic Tension Type Headache, run by NMP Medical Research Institute at 1 site in India.
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 3 inclusion and 6 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: finished, as of the sponsor's last update on 8 Dec 2011. 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 India. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Frequency of headache (time frame: 3 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 8 Dec 2011; AzTrials last refreshed its copy on 28 Oct 2026.