Yoga Intervention Study on Episodic Tension Type Headache

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
NMP Medical Research Institute
ClinicalTrials.gov Identifier:
NCT01488825
First received: December 6, 2011
Last updated: December 7, 2011
Last verified: December 2011
  Purpose

The present study was designed to evaluate effect of yoga intervention on patients having frequent tension type headache.


Condition Intervention Phase
Episodic Tension Type Headache
Behavioral: Yoga Therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Yoga Intervention on Episodic Tension Type Headache: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by NMP Medical Research Institute:

Primary Outcome Measures:
  • Frequency of headache [ Time Frame: 3 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Duration of Headache [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Severity of headache [ Time Frame: 3 Months ] [ Designated as safety issue: No ]
  • Analgesic consumption [ Time Frame: 3 Months ] [ Designated as safety issue: No ]
  • Anxiety levels [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Depression [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Stress [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 77
Study Start Date: January 2005
Study Completion Date: June 2006
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
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: 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

No publications provided

Responsible Party: NMP Medical Research Institute
ClinicalTrials.gov Identifier: NCT01488825     History of Changes
Other Study ID Numbers: NMP-0090-YR
Study First Received: December 6, 2011
Last Updated: December 7, 2011
Health Authority: India: Indian Council of Medical Research

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

ClinicalTrials.gov processed this record on July 23, 2014