Yoga Intervention Study on Episodic Tension Type Headache

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.

Study Overview

• Status: Completed
• Conditions: Episodic Tension Type Headache
• Intervention / Treatment: Behavioral: Yoga Therapy

• Study Type: Interventional
• Enrollment (Actual): 77
• Phase: Phase 2

Contacts and Locations

Study Locations

• India
  • Rajasthan
    • Jaipur, Rajasthan, India, 302019
      • Pain Clinic, NMP Medical Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Frequency of headache	3 Months

Secondary Outcome Measures

Outcome Measure	Time Frame
Duration of Headache	3 months
Severity of headache	3 Months
Analgesic consumption	3 Months
Anxiety levels	3 months
Depression	3 months
Stress	3 months

Collaborators and Investigators

• Sponsor: NMP Medical Research Institute
• Investigators: Principal Investigator: Neha Sharma, PhD, NMP Medical Research Institute

Study record dates

Study Major Dates

• Study Start: January 1, 2005
• Primary Completion (Actual): February 1, 2006
• Study Completion (Actual): June 1, 2006

Study Registration Dates

• First Submitted: December 6, 2011
• First Submitted That Met QC Criteria: December 7, 2011
• First Posted (Estimate): December 8, 2011

Study Record Updates

• Last Update Posted (Estimate): December 8, 2011
• Last Update Submitted That Met QC Criteria: December 7, 2011
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders, Primary; Headache Disorders; Headache; Tension-Type Headache
• Other Study ID Numbers: NMP-0090-YR