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Yoga Intervention Study on Episodic Tension Type Headache

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01488825
Recruitment Status : Completed
First Posted : December 8, 2011
Last Update Posted : December 8, 2011
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The present study was designed to evaluate effect of yoga intervention on patients having frequent tension type headache.

Condition or disease Intervention/treatment Phase
Episodic Tension Type Headache Behavioral: Yoga Therapy Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 77 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Yoga Intervention on Episodic Tension Type Headache: A Randomized Controlled Trial
Study Start Date : January 2005
Primary Completion Date : February 2006
Study Completion Date : June 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
No Intervention: Wait-list control group
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.
Experimental: Yoga Intervention Group
The yoga sessions developed specifically for study participant consisted of 12 weekly 60-minute designed to benefit in episodic tension type headache.
Behavioral: Yoga Therapy
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.


Outcome Measures

Primary Outcome Measures :
  1. Frequency of headache [ Time Frame: 3 Months ]

Secondary Outcome Measures :
  1. Duration of Headache [ Time Frame: 3 months ]
  2. Severity of headache [ Time Frame: 3 Months ]
  3. Analgesic consumption [ Time Frame: 3 Months ]
  4. Anxiety levels [ Time Frame: 3 months ]
  5. Depression [ Time Frame: 3 months ]
  6. Stress [ Time Frame: 3 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • aged between 18 to 60 years
  • more than 5 but fewer than 15 headache episodes per month
  • headache intensity moderate to severe

Exclusion Criteria:

  • 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01488825


Locations
India
Pain Clinic, NMP Medical Research Institute
Jaipur, Rajasthan, India, 302019
Sponsors and Collaborators
NMP Medical Research Institute
Investigators
Principal Investigator: Neha SHARMA, PhD NMP Medical Research Institute
More Information

Responsible Party: NMP Medical Research Institute
ClinicalTrials.gov Identifier: NCT01488825     History of Changes
Other Study ID Numbers: NMP-0090-YR
First Posted: December 8, 2011    Key Record Dates
Last Update Posted: December 8, 2011
Last Verified: December 2011

Additional relevant MeSH terms:
Headache
Tension-Type Headache
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases