Yoga Nasal Irrigation in the Treatment of Chronic Tension Type Headache

Chronic Tension-Type Headache Clinical Trial

Official title:

Yoga Nasal Irrigation in the Treatment of Chronic Tension Type Headache: Randomised Waitlist Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04113512
• Other study ID #: NMP/98672
• Status: Completed
• Phase: N/A
• Start date: March 15, 2019
• Est. completion date: July 26, 2019

Study information

• Verified date: October 2019
• Source: NMP Medical Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the effectiveness of Yoga Nasal Irrigation (Jalaneti) on patients with chronic tension-type headache reducing pain and disability.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: July 26, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Tension-Type Headache
• Headache
• Tension-Type Headache

Intervention

Other:
• Jalaneti
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

Locations

Country	Name	City	State
India	Yoga Bhavan	Jaipur	Rajasthan

Sponsors (3)

Lead Sponsor	Collaborator
NMP Medical Research Institute	University of Rajasthan, Yog-Kulam, UK

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Headache Frequency	Number of days with headache was assessed using headache diary	Change from baseline to 6 weeks
Secondary	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	Change from baseline to 6 weeks
Secondary	Duration of Headache	Duration of each headache attack (hours per day)	Change from baseline to 6 weeks
Secondary	Headache disability	Disability caused by headache was measure using Headache Impact Test (HIT-6).	Change from baseline to 6 weeks