Yoga Nasal Irrigation in the Treatment of Chronic Tension Type Headache

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

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

Study Overview

• Status: Completed
• Conditions: Chronic Tension-Type Headache
• Intervention / Treatment: Other: Jalaneti

• Study Type: Interventional
• Enrollment (Actual): 98
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Rajasthan
    • Jaipur, Rajasthan, India
      • Yoga Bhavan

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:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Yoga Nasal Irrigation Group; Saline nasal irrigation using neti pot was practiced.	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
NO_INTERVENTION: Wait list Control group; Group was given usual pain medication. After trial period, they were offered the intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Headache Frequency	Number of days with headache was assessed using headache diary	Change from baseline to 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Duration of Headache	Duration of each headache attack (hours per day)	Change from baseline to 6 weeks
Headache disability	Disability caused by headache was measure using Headache Impact Test (HIT-6).	Change from baseline to 6 weeks

Collaborators and Investigators

• Sponsor: NMP Medical Research Institute
• Collaborators: Yog-Kulam; University of Rajasthan
• Investigators: Study Director: Shekhar Sharma, NMP Medical Research Institute, India; Study Chair: Placheril John, PhD, University of Rajasthan, India

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 15, 2019
• Primary Completion (ACTUAL): June 30, 2019
• Study Completion (ACTUAL): July 26, 2019

Study Registration Dates

• First Submitted: October 1, 2019
• First Submitted That Met QC Criteria: October 1, 2019
• First Posted (ACTUAL): October 2, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 2, 2019
• Last Update Submitted That Met QC Criteria: October 1, 2019
• Last Verified: October 1, 2019

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/98672

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No