Chronic Tension-Type HeadacheNCT03862638
Yoga Therapy for Chronic Tension-Type Headache
A study testing Yoga Therapy in people with Chronic Tension-Type Headache, run by NMP Medical Research Institute at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Chronic Tension-Type Headache
- What is being tested?
- Yoga Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteIndia
- Study dates
- 10 Apr 2010to 15 Jan 2013
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- Diagnosed psychiatric condition
- Taking any other complementary and alternative medicines
- Practicing yoga of any kind in last three months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Yoga Therapy for Chronic Tension-Type Headache: An Evaluation Study
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.
- Conditions
- Chronic Tension-Type Headache
- Being tested
- Yoga Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yoga TherapyOther
Also called Yoga
Yoga therapy is therapeutic application of yoga, specifically designed to treat the condition using physical posture, breathing exercises, guided relaxation and meditation.
| Study group | Role | What they receive |
|---|---|---|
| Yoga Therapy | Experimental | Yoga therapy session lasted for 60 minutes consisting physical posture, Breath work, Relaxation, guided meditation, chants and combination techniques for groups sessions. Receives: Other: Yoga Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of days with headache
Number of days with headache every four weeks were assessed through headache diaries
Measured: Change from baseline to 12-week of intervention
Secondary outcomes (3)
The medication intake
Medication score per month were recorded through headache diaries
Measured: Change from baseline to 12 week of intervention
Intensity of Pan
Each headache intensity was measure through 0-10 scale; 0 was no pain and 10 was worst pain
Measured: Change from baseline to12 week of intervention
Duration of Pain
Duration of each headache was measured through headache diaries
Measured: Change from baseline to12 week of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2019
- Study start10 Apr 2010
- Primary completion12 Dec 2012
- Study completion15 Jan 2013
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- NMP Medical Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Yog-Kulam, Department of Zoology, University of Rajasthan, India
- Responsible party
- Sponsor
- Investigators
- Neha Sharma, PhD, Principal investigator, Yog-KulamPJ John, PhD, Study director, Deaprtment of Zoology, University of RajasthanChandra M Sharma, DM, Study chair, SMS Medical College and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03862638
- Sponsor's protocol ID
- NMP/23891
- Status last verified
- Mar 2019
- First submitted
- 28 Feb 2019
- Last updated
- 5 Mar 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 5 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Yoga Therapy for Chronic Tension-Type Headache: An Evaluation Study
- ClinicalTrials.gov ID
- NCT03862638
- Acronym / sponsor ID
- NMP/23891
- Conditions
- Chronic Tension-Type Headache
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- NMP Medical Research InstituteUniversity, hospital or other
- Collaborators
- Yog-Kulam, Department of Zoology, University of Rajasthan, India
- Study start
- 10 Apr 2010 (actual)
- Primary completion
- 12 Dec 2012 (actual)
- Study completion
- 15 Jan 2013 (actual)
- First posted
- 5 Mar 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Yoga Therapy | Experimental | Other: Yoga TherapyYoga therapy session lasted for 60 minutes consisting physical posture, Breath work, Relaxation, guided meditation, chants and combination techniques for groups sessions. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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;
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 |
|---|---|---|
| Yoga TherapyAlso: YogaYoga therapy is therapeutic application of yoga, specifically designed to treat the condition using physical posture, breathing exercises, guided relaxation and meditation. | Other | Yoga Therapy |
Primary outcome
The number of days with headache
Time frame: Change from baseline to 12-week of intervention
Number of days with headache every four weeks were assessed through headache diaries
3 secondary outcomes
The medication intake
Time frame: Change from baseline to 12 week of intervention
Intensity of Pan
Time frame: Change from baseline to12 week of intervention
Duration of Pain
Time frame: Change from baseline to12 week of intervention
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 5 Mar 2019.
- Individual participant dataSharing planned: Undecided
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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
PJ John, PhD study director
Deaprtment of Zoology, University of Rajasthan
Chandra M Sharma, DM study chair
SMS Medical College and Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga Therapy 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 4 inclusion and 9 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 5 Mar 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?
The number of days with headache (time frame: Change from baseline to 12-week of intervention). 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 5 Mar 2019.