Chronic Tension-Type HeadacheNCT04113512
Yoga Nasal Irrigation in the Treatment of Chronic Tension Type Headache
A study testing Jalaneti in people with Chronic Tension-Type Headache, run by NMP Medical Research Institute at 1 site in India.
Trial summary
To evaluate the effectiveness of Yoga Nasal Irrigation (Jalaneti) on patients with chronic tension-type headache reducing pain and disability. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Chronic Tension-Type Headache
- What is being tested?
- Jalaneti
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteIndia
- Study dates
- 15 Mar 2019to 26 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Chronic Tension-Type Headache
- Being tested
- Jalaneti
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JalanetiOther
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
| Study group | Role | What they receive |
|---|---|---|
| Yoga Nasal Irrigation Group | Experimental | Saline nasal irrigation using neti pot was practiced. Receives: Other: Jalaneti |
| Wait list Control group | No intervention | Group was given usual pain medication. After trial period, they were offered the intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Headache Frequency
Number of days with headache was assessed using headache diary
Measured: Change from baseline to 6 weeks
Secondary outcomes (3)
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
Measured: Change from baseline to 6 weeks
Duration of Headache
Duration of each headache attack (hours per day)
Measured: Change from baseline to 6 weeks
Headache disability
Disability caused by headache was measure using Headache Impact Test (HIT-6).
Measured: Change from baseline to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2019
- Study start15 Mar 2019
- Primary completion30 Jun 2019
- Study completion26 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Tension-Type HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- NMP Medical Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- University of Rajasthan, Yog-Kulam
- Responsible party
- Sponsor
- Investigators
- Neha Sharma, PhD, Principal investigator, Yog-KulamJaydeep Joshi, Study chair, Yog-KulamPlacheril John, PhD, Study chair, University of Rajasthan, IndiaShekhar Sharma, Study director, NMP Medical Research Institute, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04113512
- Sponsor's protocol ID
- NMP/98672
- Status last verified
- Oct 2019
- First submitted
- 1 Oct 2019
- Last updated
- 2 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Yoga Nasal Irrigation in the Treatment of Chronic Tension Type Headache: Randomised Waitlist Controlled Trial
- ClinicalTrials.gov ID
- NCT04113512
- Acronym / sponsor ID
- NMP/98672
- Conditions
- Chronic Tension-Type Headache
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- NMP Medical Research InstituteUniversity, hospital or other
- Collaborators
- University of Rajasthan, Yog-Kulam
- Study start
- 15 Mar 2019 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 26 Jul 2019 (actual)
- First posted
- 2 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the effectiveness of Yoga Nasal Irrigation (Jalaneti) on patients with chronic tension-type headache reducing pain and disability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yoga Nasal Irrigation Group | Experimental | Other: JalanetiSaline nasal irrigation using neti pot was practiced. |
| Wait list Control group | No intervention | –Group was given usual pain medication. After trial period, they were offered the intervention. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JalanetiSterilised 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 | Other | Yoga Nasal Irrigation Group |
Primary outcome
Headache Frequency
Time frame: Change from baseline to 6 weeks
Number of days with headache was assessed using headache diary
3 secondary outcomes
Headache severity
Time frame: Change from baseline to 6 weeks
Duration of Headache
Time frame: Change from baseline to 6 weeks
Headache disability
Time frame: Change from baseline to 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Chronic Tension-Type Headache
Recruiting
BioTenCer: Biofeedback as Preventive Treatment in Tension Type Headache
Tension Type Headache
Recruiting
Dance-therapy and Chronic Pain
Chronic Pain, Complex Regional Pain Syndromes
Not yet recruiting
Fire Needling Plus Filiform Needling for Chronic Migraine With Comorbid Tension-Type Headache
Chronic Migraine, Tension-type Headache
Not yet recruiting
Efficacy of a Multimodal Physiotherapy Program and Mobile-App Guided Meditation in Adults With Frequent or Chronic Tension-Type Headache
Tension-Type Headache, Chronic Tension-type Headache
Recruiting
Low-Energy Ultrasound, Electrical and Magnetic Field Stimulation in Therapy-Resistant Myofascial Pain Syndrome
Myofascial Pain Syndrome - Lower Back, Myofascial Pain Syndrome - Neck
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neha Sharma, PhD principal investigator
Yog-Kulam
Jaydeep Joshi study chair
Yog-Kulam
Placheril John, PhD study chair
University of Rajasthan, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Jalaneti in people with Chronic Tension-Type Headache, run by NMP Medical Research Institute at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Headache Frequency (time frame: Change from baseline to 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2019.