Yoga Intervention Study on Episodic Tension Type Headache
Effect of Yoga Intervention on Episodic Tension Type Headache: A Randomized Controlled Trial
1 other identifier
interventional
77
1 country
1
Brief Summary
The present study was designed to evaluate effect of yoga intervention on patients having frequent tension type headache.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jan 2005
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2006
CompletedFirst Submitted
Initial submission to the registry
December 6, 2011
CompletedFirst Posted
Study publicly available on registry
December 8, 2011
CompletedDecember 8, 2011
December 1, 2011
1.1 years
December 6, 2011
December 7, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Frequency of headache
3 Months
Secondary Outcomes (6)
Duration of Headache
3 months
Severity of headache
3 Months
Analgesic consumption
3 Months
Anxiety levels
3 months
Depression
3 months
- +1 more secondary outcomes
Study Arms (2)
Wait-list control group
NO INTERVENTIONThe 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
EXPERIMENTALThe yoga sessions developed specifically for study participant consisted of 12 weekly 60-minute designed to benefit in episodic tension type headache.
Interventions
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.
Eligibility Criteria
You may qualify if:
- aged between 18 to 60 years
- more than 5 but fewer than 15 headache episodes per month
- headache intensity moderate to severe
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pain Clinic, NMP Medical Research Institute
Jaipur, Rajasthan, 302019, India
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Neha SHARMA, PhD
NMP Medical Research Institute
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 6, 2011
First Posted
December 8, 2011
Study Start
January 1, 2005
Primary Completion
February 1, 2006
Study Completion
June 1, 2006
Last Updated
December 8, 2011
Record last verified: 2011-12