Back to resultsYoga Nasal Irrigation in the Treatment of Chronic Tension Type Headache
Primary Purpose
Chronic Tension-Type Headache
Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Jalaneti
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 chronic tension type headache as per International Classification of Headache Disorders, 3rd edition (beta version) (ICHD-3 beta criteria)
- Aged 18-60 years;
- Ability of understand and completing the headache dairy;
- Volunteering to the study
- Provide written informed consent.
Exclusion Criteria:
- Not having tension-type headache during the pervious 3 months or having less than 8 episode of tension type headache in serious month.
- Taking any prophylactic headache medication or complementary and alternative medicine in last 3 month;
- Secondary Headaches
- In pregnancy, lactation, or planning to be pregnant in 6 months
- Having nose bleeding disorders or recurrent infections;
- Psychiatric diagnosis or medication history
Sites / Locations
- Yoga Bhavan
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Yoga Nasal Irrigation Group
Wait list Control group
Arm Description
Saline nasal irrigation using neti pot was practiced.
Group was given usual pain medication. After trial period, they were offered the intervention.
Outcomes
Primary Outcome Measures
Headache Frequency
Number of days with headache was assessed using headache diary
Secondary Outcome Measures
Headache severity
Mean pain intensity of tension-type headache measured using Visual Analogue Scale from 0-10, 0 defined as no pain and 10 defined as an unbearable pain
Duration of Headache
Duration of each headache attack (hours per day)
Headache disability
Disability caused by headache was measure using Headache Impact Test (HIT-6).
Full Information
NCT ID
NCT04113512
First Posted
October 1, 2019
Last Updated
October 1, 2019
Sponsor
NMP Medical Research Institute
Collaborators
University of Rajasthan, Yog-Kulam
1. Study Identification
Unique Protocol Identification Number
NCT04113512
Brief Title
Yoga Nasal Irrigation in the Treatment of Chronic Tension Type Headache
Official Title
Yoga Nasal Irrigation in the Treatment of Chronic Tension Type Headache: Randomised Waitlist Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
March 15, 2019 (Actual)
Primary Completion Date
June 30, 2019 (Actual)
Study Completion Date
July 26, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NMP Medical Research Institute
Collaborators
University of Rajasthan, Yog-Kulam
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
To evaluate the effectiveness of Yoga Nasal Irrigation (Jalaneti) on patients with chronic tension-type headache reducing pain and disability.
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
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
98 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Yoga Nasal Irrigation Group
Arm Type
Experimental
Arm Description
Saline nasal irrigation using neti pot was practiced.
Arm Title
Wait list Control group
Arm Type
No Intervention
Arm Description
Group was given usual pain medication. After trial period, they were offered the intervention.
Intervention Type
Other
Intervention Name(s)
Jalaneti
Intervention Description
Sterilised and lukewarm isotonic salt water using neti pot was poured into one nostril, so that it leaves through the other. The procedure is then repeated on the other side, and the nose is dried by bending forward and by rapid yoga breathing
Primary Outcome Measure Information:
Title
Headache Frequency
Description
Number of days with headache was assessed using headache diary
Time Frame
Change from baseline to 6 weeks
Secondary Outcome Measure Information:
Title
Headache severity
Description
Mean pain intensity of tension-type headache measured using Visual Analogue Scale from 0-10, 0 defined as no pain and 10 defined as an unbearable pain
Time Frame
Change from baseline to 6 weeks
Title
Duration of Headache
Description
Duration of each headache attack (hours per day)
Time Frame
Change from baseline to 6 weeks
Title
Headache disability
Description
Disability caused by headache was measure using Headache Impact Test (HIT-6).
Time Frame
Change from baseline to 6 weeks
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:
Meeting the diagnostic criteria of chronic tension type headache as per International Classification of Headache Disorders, 3rd edition (beta version) (ICHD-3 beta criteria)
Aged 18-60 years;
Ability of understand and completing the headache dairy;
Volunteering to the study
Provide written informed consent.
Exclusion Criteria:
Not having tension-type headache during the pervious 3 months or having less than 8 episode of tension type headache in serious month.
Taking any prophylactic headache medication or complementary and alternative medicine in last 3 month;
Secondary Headaches
In pregnancy, lactation, or planning to be pregnant in 6 months
Having nose bleeding disorders or recurrent infections;
Psychiatric diagnosis or medication history
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
Jaydeep Joshi
Organizational Affiliation
Yog-Kulam
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Placheril John, PhD
Organizational Affiliation
University of Rajasthan, India
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Shekhar Sharma
Organizational Affiliation
NMP Medical Research Institute, India
Official's Role
Study Director
Facility Information:
Facility Name
Yoga Bhavan
City
Jaipur
State/Province
Rajasthan
Country
India
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Yoga Nasal Irrigation in the Treatment of Chronic Tension Type Headache
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