Tension-Type Headache
Conditions
Keywords
Tension-Type Headache, Yoga, Mindfulness-based stress reduction
Brief 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. 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.
Interventions
BEHAVIORALIyengar Yoga
Classical Iyengar Yoga intervention, especially designed for headache patients. Note: First administered face-to-face, due to Covid-restrictions changed to online classes
BEHAVIORALMindfulness-based stress reduction
Standardazied Mindfulness-based stress reduction intervention Note: First administered face-to-face, due to Covid-restrictions changed to online classes
Sponsors
Eden Stiftung
Universität Duisburg-Essen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Headache Frequency | post-intervention (8 weeks) | Headache Frequency self-reported by a headache diary |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of headache episodes | post-intervention (8 weeks) | Duration of headache episodes self-reported by a headache diary |
| Pain Intensity | post-intervention (8 weeks) | Numeric rating scale |
| Pain medication use | post-intervention (8 weeks) | Pain medication use self-reported by a headache diary |
| Headache related disability | post-intervention (8 weeks) | Headche Impact Test 6 (HIT-6) |
| Health-related quality of life | post-intervention (8 weeks) | SF-36 questionaire |
| Anxiety | post-intervention (8 weeks) | Depression and Anxiety scale (DAAS) |
| Headache Frequency | follow-up (20 weeks) | Headache Frequency self-reported by a headache diary |
| Pain catastrophizing | post-intervention (8 weeks) | Pain catastrophizing scale (PCS) |
| Pain acceptance | post-intervention (8 weeks) | Chronic pain acceptance questionaire (CPAQ) |
| Mindfulness | post-intervention (8 weeks) | Mindfulness Attention and Awerness scale (MAAS) |
| Body Awareness | post-intervention (8 weeks) | Body Awareness questionaire (BAQ) |
| Safety | post-intervention (8 weeks) | Adverse events |
| Stress | post-intervention (8 weeks) | Depression and Anxiety scale (DAAS) |
Countries
Germany
Outcome results
None listed