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Completed

NCT Number: NCT04867967

Yoga and MBSR for TTH

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. 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.

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Key information

Conditions

Tension-type Headache Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Evang. Kliniken Essen-Mitte

Essen, North Rhine-Westphalia, 45276, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • episodic or chronic tension-type headache according to ICHD-3 definition

Exclusion criteria

  • 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

Treatment and study plan

Iyengar Yoga

Behavioral

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 Reduction

Behavioral

Standardazied Mindfulness-based stress reduction intervention Note: First administered face-to-face, due to Covid-restrictions changed to online classes

Primary outcomes

  1. Headache Frequency

    Time frame: post-intervention (8 weeks)

    Headache Frequency self-reported by a headache diary

Secondary outcomes

  1. Headache Frequency

    Time frame: follow-up (20 weeks)

    Headache Frequency self-reported by a headache diary

  2. Duration of headache episodes

    Time frame: post-intervention (8 weeks)

    Duration of headache episodes self-reported by a headache diary

  3. Duration of headache episodes

    Time frame: follow-up (20 weeks)

    Duration of headache episodes self-reported by a headache diary

  4. Pain Intensity

    Time frame: post-intervention (8 weeks)

    Numeric rating scale

  5. Pain Intensity

    Time frame: follow-up (20 weeks)

    Numeric rating scale (NRS)

  6. Pain medication use

    Time frame: post-intervention (8 weeks)

    Pain medication use self-reported by a headache diary

  7. Pain medication use

    Time frame: follow-up (20 weeks)

    Pain medication use self-reported by a headache diary

  8. Headache related disability

    Time frame: post-intervention (8 weeks)

    Headche Impact Test 6 (HIT-6)

  9. Headache related disability

    Time frame: follow-up (20 weeks)

    Headche Impact Test 6 (HIT-6)

  10. Health-related quality of life

    Time frame: post-intervention (8 weeks)

    SF-36 questionaire

  11. Health-related quality of life

    Time frame: follow-up (20 weeks)

    SF-36 questionaire

  12. Anxiety

    Time frame: post-intervention (8 weeks)

    Depression and Anxiety scale (DAAS)

  13. Anxiety

    Time frame: follow-up (20 weeks)

    Depression and Anxiety scale (DAAS)

  14. Stress

    Time frame: post-intervention (8 weeks)

    Depression and Anxiety scale (DAAS)

  15. Stress

    Time frame: follow-up (20 weeks)

    Depression and Anxiety scale (DAAS)

  16. Pain catastrophizing

    Time frame: post-intervention (8 weeks)

    Pain catastrophizing scale (PCS)

  17. Pain catastrophizing

    Time frame: follow-up (20 weeks)

    Pain catastrophizing scale (PCS)

  18. Pain acceptance

    Time frame: post-intervention (8 weeks)

    Chronic pain acceptance questionaire (CPAQ)

  19. Pain acceptance

    Time frame: follow-up (20 weeks)

    Chronic pain acceptance questionaire (CPAQ)

  20. Mindfulness

    Time frame: post-intervention (8 weeks)

    Mindfulness Attention and Awerness scale (MAAS)

  21. Mindfulness

    Time frame: follow-up (20 weeks)

    Mindfulness Attention and Awerness scale (MAAS)

  22. Body Awareness

    Time frame: post-intervention (8 weeks)

    Body Awareness questionaire (BAQ)

  23. Body Awareness

    Time frame: follow-up (20 weeks)

    Body Awareness questionaire (BAQ)

  24. Safety

    Time frame: post-intervention (8 weeks)

    Adverse events

  25. Safety

    Time frame: follow-up (20 weeks)

    Adverse events

Sponsors and collaborators

Lead sponsor

Universität Duisburg-Essen

Other

Collaborators

  • Eden Stiftung

Registry information

Official study title

Yoga and Mindfulnes-based-stress-reduction for Patients With Tension-type Headache

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Apr 30, 2021
Registry last updated
Apr 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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