Tension-Type HeadacheNCT04867967
Yoga and MBSR for TTH
A study testing Iyengar Yoga and Mindfulness-based stress reduction in people with Tension-Type Headache, run by Universität Duisburg-Essen at 1 site in Germany.
Trial summary
Primary study objectives 1. evaluate the short-term effect of yoga intervention in addition to routine care on headache frequency in patients with frequent or chronic tension-type headache compared to routine care alone (waiting group). 2. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tension-Type Headache
- What is being tested?
- Iyengar Yoga and Mindfulness-based stress reduction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteGermany
- Study dates
- 1 Feb 2019to 30 Dec 2021
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- episodic or chronic tension-type headache according to ICHD-3 definition
Who cannot join
- medication induced headache according to ICHD-3 definition
- Cluster-headache according to ICHD-3 definition
- serious chronic systemic or acute physical or mental illness
- Dementia
- Pregnancy
- actual in a yoga or MBSR class
Trial locations and contacts
1 site in 1 country.
Germany1 site
Evang. Kliniken Essen-Mitte
Essen, North Rhine-Westphalia, 45276
About this study
Official title: Yoga and Mindfulnes-based-stress-reduction for Patients With Tension-type Headache
Primary study objectives
- evaluate the short-term effect of yoga intervention in addition to routine care on headache frequency in patients with frequent or chronic tension-type headache compared to routine care alone (waiting group).
- to evaluate the short-term effect of yoga intervention in addition to routine care on headache frequency in patients with frequent episodic or chronic tension-type headache compared with stress management through mindfulness-based stress reduction (MBSR) in addition to routine care.
Read more
Secondary study objectives
Evaluation of the medium-term effect of the intervention on headache frequency as well as the short- and medium-term effect on the secondary target parameters in comparison to the waiting group and MBSR. Further evaluation of the safety and acceptability of the intervention.
- Conditions
- Tension-Type Headache
- Being tested
- Iyengar Yoga, Mindfulness-based stress reduction
- Keywords
- Tension-Type Headache, Yoga, Mindfulness-based stress reduction
- Medical subject headings
- Tension-Type Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iyengar YogaBehavioural
Classical Iyengar Yoga intervention, especially designed for headache patients. Note: First administered face-to-face, due to Covid-restrictions changed to online classes
Mindfulness-based stress reductionBehavioural
Standardazied Mindfulness-based stress reduction intervention Note: First administered face-to-face, due to Covid-restrictions changed to online classes
| Study group | Role | What they receive |
|---|---|---|
| Iyengar Yoga Intervention | Experimental | 8-week yoga class; once weekly; 90 minutes
Note: First administered face-to-face, due to Covid-restrictions changed to online classes Receives: Behavioral: Iyengar Yoga |
| Mindfulness-based stress reduction | Active comparator | 8-week MBSR class; once weekly; 90 minutes
Note: First administered face-to-face, due to Covid-restrictions changed to online classes Receives: Behavioral: Mindfulness-based stress reduction |
| Waitlist control | No intervention | Waitlist control, ususal care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Headache Frequency
Headache Frequency self-reported by a headache diary
Measured: post-intervention (8 weeks)
Secondary outcomes (25)
Headache Frequency
Headache Frequency self-reported by a headache diary
Measured: follow-up (20 weeks)
Duration of headache episodes
Duration of headache episodes self-reported by a headache diary
Measured: post-intervention (8 weeks)
Duration of headache episodes
Duration of headache episodes self-reported by a headache diary
Measured: follow-up (20 weeks)
Pain Intensity
Numeric rating scale
Measured: post-intervention (8 weeks)
Pain Intensity
Numeric rating scale (NRS)
Measured: follow-up (20 weeks)
Pain medication use
Pain medication use self-reported by a headache diary
Measured: post-intervention (8 weeks)
Pain medication use
Pain medication use self-reported by a headache diary
Measured: follow-up (20 weeks)
Headache related disability
Headche Impact Test 6 (HIT-6)
Measured: post-intervention (8 weeks)
Headache related disability
Headche Impact Test 6 (HIT-6)
Measured: follow-up (20 weeks)
Health-related quality of life
SF-36 questionaire
Measured: post-intervention (8 weeks)
Health-related quality of life
SF-36 questionaire
Measured: follow-up (20 weeks)
Anxiety
Depression and Anxiety scale (DAAS)
Measured: post-intervention (8 weeks)
Anxiety
Depression and Anxiety scale (DAAS)
Measured: follow-up (20 weeks)
Stress
Depression and Anxiety scale (DAAS)
Measured: post-intervention (8 weeks)
Stress
Depression and Anxiety scale (DAAS)
Measured: follow-up (20 weeks)
Pain catastrophizing
Pain catastrophizing scale (PCS)
Measured: post-intervention (8 weeks)
Pain catastrophizing
Pain catastrophizing scale (PCS)
Measured: follow-up (20 weeks)
Pain acceptance
Chronic pain acceptance questionaire (CPAQ)
Measured: post-intervention (8 weeks)
Pain acceptance
Chronic pain acceptance questionaire (CPAQ)
Measured: follow-up (20 weeks)
Mindfulness
Mindfulness Attention and Awerness scale (MAAS)
Measured: post-intervention (8 weeks)
Mindfulness
Mindfulness Attention and Awerness scale (MAAS)
Measured: follow-up (20 weeks)
Body Awareness
Body Awareness questionaire (BAQ)
Measured: post-intervention (8 weeks)
Body Awareness
Body Awareness questionaire (BAQ)
Measured: follow-up (20 weeks)
Safety
Adverse events
Measured: post-intervention (8 weeks)
Safety
Adverse events
Measured: follow-up (20 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2021
- Study start1 Feb 2019
- Primary completion30 Aug 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universität Duisburg-Essen
- Sponsor type
- University, hospital or other
- Collaborators
- Eden Stiftung
- Responsible party
- Principal investigator, Holger Cramer, Universität Duisburg-Essen
- Investigators
- Gustav Dobos, MD, Study chair, University of Duisburg-Essen, Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04867967
- Sponsor's protocol ID
- 17-7925 BO
- Status last verified
- Apr 2025
- First submitted
- 29 Apr 2021
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Yoga and Mindfulnes-based-stress-reduction for Patients With Tension-type Headache
- ClinicalTrials.gov ID
- NCT04867967
- Acronym / sponsor ID
- 17-7925 BO
- Conditions
- Tension-Type Headache
- Keywords
- Tension-Type Headache, Yoga, Mindfulness-based stress reduction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Universität Duisburg-EssenUniversity, hospital or other
- Collaborators
- Eden Stiftung
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 30 Aug 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 30 Apr 2021 (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.
Primary study objectives
- evaluate the short-term effect of yoga intervention in addition to routine care on headache frequency in patients with frequent or chronic tension-type headache compared to routine care alone (waiting group).
- to evaluate the short-term effect of yoga intervention in addition to routine care on headache frequency in patients with frequent episodic or chronic tension-type headache compared with stress management through mindfulness-based stress reduction (MBSR) in addition to routine care.
Secondary study objectives
Evaluation of the medium-term effect of the intervention on headache frequency as well as the short- and medium-term effect on the secondary target parameters in comparison to the waiting group and MBSR. Further evaluation of the safety and acceptability of the intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Iyengar Yoga Intervention | Experimental | Behavioral: Iyengar Yoga8-week yoga class; once weekly; 90 minutes Note: First administered face-to-face, due to Covid-restrictions changed to online classes |
| Mindfulness-based stress reduction | Active comparator | Behavioral: Mindfulness-based stress reduction8-week MBSR class; once weekly; 90 minutes Note: First administered face-to-face, due to Covid-restrictions changed to online classes |
| Waitlist control | No intervention | –Waitlist control, ususal care |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- episodic or chronic tension-type headache according to ICHD-3 definition
Key exclusion criteria (6 listed)
- medication induced headache according to ICHD-3 definition
- Cluster-headache according to ICHD-3 definition
- serious chronic systemic or acute physical or mental illness
- Dementia
- Pregnancy
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 |
|---|---|---|
| Iyengar YogaClassical Iyengar Yoga intervention, especially designed for headache patients. Note: First administered face-to-face, due to Covid-restrictions changed to online classes | Behavioural | Iyengar Yoga Intervention |
| Mindfulness-based stress reductionStandardazied Mindfulness-based stress reduction intervention Note: First administered face-to-face, due to Covid-restrictions changed to online classes | Behavioural | Mindfulness-based stress reduction |
Primary outcome
Headache Frequency
Time frame: post-intervention (8 weeks)
Headache Frequency self-reported by a headache diary
25 secondary outcomes
Headache Frequency
Time frame: follow-up (20 weeks)
Duration of headache episodes
Time frame: post-intervention (8 weeks)
Duration of headache episodes
Time frame: follow-up (20 weeks)
Pain Intensity
Time frame: post-intervention (8 weeks)
Pain Intensity
Time frame: follow-up (20 weeks)
Pain medication use
Time frame: post-intervention (8 weeks)
Pain medication use
Time frame: follow-up (20 weeks)
Headache related disability
Time frame: post-intervention (8 weeks)
Headache related disability
Time frame: follow-up (20 weeks)
Health-related quality of life
Time frame: post-intervention (8 weeks)
Health-related quality of life
Time frame: follow-up (20 weeks)
Anxiety
Time frame: post-intervention (8 weeks)
Anxiety
Time frame: follow-up (20 weeks)
Stress
Time frame: post-intervention (8 weeks)
Stress
Time frame: follow-up (20 weeks)
Pain catastrophizing
Time frame: post-intervention (8 weeks)
Pain catastrophizing
Time frame: follow-up (20 weeks)
Pain acceptance
Time frame: post-intervention (8 weeks)
Pain acceptance
Time frame: follow-up (20 weeks)
Mindfulness
Time frame: post-intervention (8 weeks)
Mindfulness
Time frame: follow-up (20 weeks)
Body Awareness
Time frame: post-intervention (8 weeks)
Body Awareness
Time frame: follow-up (20 weeks)
Safety
Time frame: post-intervention (8 weeks)
Safety
Time frame: follow-up (20 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 4 Apr 2025.
- Individual participant dataSharing planned: No
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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.
Gustav Dobos, MD study chair
University of Duisburg-Essen, Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Iyengar Yoga and Mindfulness-based stress reduction in people with Tension-Type Headache, run by Universität Duisburg-Essen at 1 site in Germany.
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 1 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 4 Apr 2025. 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 Germany. 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: post-intervention (8 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 4 Apr 2025; AzTrials last refreshed its copy on 3 Nov 2026.