Back to resultsYoga Therapy for Chronic Tension-Type Headache
Primary Purpose
Chronic Tension-Type Headache
Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Yoga Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Tension-Type Headache
Eligibility Criteria
Inclusion Criteria:
- Meeting the diagnostic criteria of CTTH in the international classification of headache disorders, 3rd edition (beta version) (ICHD-III beta);
- Aged 18-55 years;
- Having the ability of understanding and completing the headache dairy;
- Provide written informed consent.
Exclusion Criteria:
- No headache during the pervious 3 months;
- Taking any prophylactic medication during the previous one month;
- Secondary headache or any systematic cause
- Having serious conditions of the heart, liver, kidney or other organs;
- In pregnancy or lactation, or planning to be pregnant in 6 months;
- Drug and Substance abuse
- Diagnosed psychiatric condition
- Taking any other complementary and alternative medicines
- Practicing yoga of any kind in last three months
Sites / Locations
- NMP Medical Research Institue
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Yoga Therapy
Arm Description
Yoga therapy session lasted for 60 minutes consisting physical posture, Breath work, Relaxation, guided meditation, chants and combination techniques for groups sessions.
Outcomes
Primary Outcome Measures
The number of days with headache
Number of days with headache every four weeks were assessed through headache diaries
Secondary Outcome Measures
The medication intake
Medication score per month were recorded through headache diaries
Intensity of Pan
Each headache intensity was measure through 0-10 scale; 0 was no pain and 10 was worst pain
Duration of Pain
Duration of each headache was measured through headache diaries
Full Information
NCT ID
NCT03862638
First Posted
February 28, 2019
Last Updated
March 2, 2019
Sponsor
NMP Medical Research Institute
Collaborators
Yog-Kulam, Department of Zoology, University of Rajasthan, India
1. Study Identification
Unique Protocol Identification Number
NCT03862638
Brief Title
Yoga Therapy for Chronic Tension-Type Headache
Official Title
Yoga Therapy for Chronic Tension-Type Headache: An Evaluation Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
April 10, 2010 (Actual)
Primary Completion Date
December 12, 2012 (Actual)
Study Completion Date
January 15, 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NMP Medical Research Institute
Collaborators
Yog-Kulam, Department of Zoology, University of Rajasthan, India
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Chronic tension headache represents a considerable social burden in terms of both costs to the health services and also the costs of lost productivity. Episodic tension-type headache can be treated with rest and analgesics, while chronic tension-type headache demands a more fundamental treatment.
Effectiveness of yoga therapy in the management of chronic tension type headache is limited. In this study, yoga therapy was used to explore its effect on chronic tension-type headache.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Tension-Type Headache
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
68 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Yoga Therapy
Arm Type
Experimental
Arm Description
Yoga therapy session lasted for 60 minutes consisting physical posture, Breath work, Relaxation, guided meditation, chants and combination techniques for groups sessions.
Intervention Type
Other
Intervention Name(s)
Yoga Therapy
Other Intervention Name(s)
Yoga
Intervention Description
Yoga therapy is therapeutic application of yoga, specifically designed to treat the condition using physical posture, breathing exercises, guided relaxation and meditation.
Primary Outcome Measure Information:
Title
The number of days with headache
Description
Number of days with headache every four weeks were assessed through headache diaries
Time Frame
Change from baseline to 12-week of intervention
Secondary Outcome Measure Information:
Title
The medication intake
Description
Medication score per month were recorded through headache diaries
Time Frame
Change from baseline to 12 week of intervention
Title
Intensity of Pan
Description
Each headache intensity was measure through 0-10 scale; 0 was no pain and 10 was worst pain
Time Frame
Change from baseline to12 week of intervention
Title
Duration of Pain
Description
Duration of each headache was measured through headache diaries
Time Frame
Change from baseline to12 week of intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Meeting the diagnostic criteria of CTTH in the international classification of headache disorders, 3rd edition (beta version) (ICHD-III beta);
Aged 18-55 years;
Having the ability of understanding and completing the headache dairy;
Provide written informed consent.
Exclusion Criteria:
No headache during the pervious 3 months;
Taking any prophylactic medication during the previous one month;
Secondary headache or any systematic cause
Having serious conditions of the heart, liver, kidney or other organs;
In pregnancy or lactation, or planning to be pregnant in 6 months;
Drug and Substance abuse
Diagnosed psychiatric condition
Taking any other complementary and alternative medicines
Practicing yoga of any kind in last three months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neha Sharma, PhD
Organizational Affiliation
Yog-Kulam
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
PJ John, PhD
Organizational Affiliation
Deaprtment of Zoology, University of Rajasthan
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Chandra M Sharma, DM
Organizational Affiliation
SMS Medical College and Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
NMP Medical Research Institue
City
Jaipur
State/Province
Rajasthan
ZIP/Postal Code
302019
Country
India
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Yoga Therapy for Chronic Tension-Type Headache
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