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Yoga Intervention Study on Episodic Tension Type Headache

Primary Purpose

Episodic Tension Type Headache

Status
Completed
Phase
Phase 2
Locations
India
Study Type
Interventional
Intervention
Yoga Therapy
Sponsored by
NMP Medical Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Episodic Tension Type Headache

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pain Clinic, NMP Medical Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Wait-list control group

Yoga Intervention Group

Arm Description

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.

The yoga sessions developed specifically for study participant consisted of 12 weekly 60-minute designed to benefit in episodic tension type headache.

Outcomes

Primary Outcome Measures

Frequency of headache

Secondary Outcome Measures

Duration of Headache
Severity of headache
Analgesic consumption
Anxiety levels
Depression
Stress

Full Information

First Posted
December 6, 2011
Last Updated
December 7, 2011
Sponsor
NMP Medical Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01488825
Brief Title
Yoga Intervention Study on Episodic Tension Type Headache
Official Title
Effect of Yoga Intervention on Episodic Tension Type Headache: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
February 2006 (Actual)
Study Completion Date
June 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NMP Medical Research Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Episodic Tension Type Headache

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
77 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Wait-list control group
Arm Type
No Intervention
Arm Description
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.
Arm Title
Yoga Intervention Group
Arm Type
Experimental
Arm Description
The yoga sessions developed specifically for study participant consisted of 12 weekly 60-minute designed to benefit in episodic tension type headache.
Intervention Type
Behavioral
Intervention Name(s)
Yoga Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Frequency of headache
Time Frame
3 Months
Secondary Outcome Measure Information:
Title
Duration of Headache
Time Frame
3 months
Title
Severity of headache
Time Frame
3 Months
Title
Analgesic consumption
Time Frame
3 Months
Title
Anxiety levels
Time Frame
3 months
Title
Depression
Time Frame
3 months
Title
Stress
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neha SHARMA, PhD
Organizational Affiliation
NMP Medical Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pain Clinic, NMP Medical Research Institute
City
Jaipur
State/Province
Rajasthan
ZIP/Postal Code
302019
Country
India

12. IPD Sharing Statement

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Yoga Intervention Study on Episodic Tension Type Headache

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