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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
72
Classical Iyengar Yoga intervention, especially designed for headache patients. Note: First administered face-to-face, due to Covid-restrictions changed to online classes
Standardazied Mindfulness-based stress reduction intervention Note: First administered face-to-face, due to Covid-restrictions changed to online classes
Evang. Kliniken Essen-Mitte
Essen, North Rhine-Westphalia, Germany
Headache Frequency
Headache Frequency self-reported by a headache diary
Time frame: post-intervention (8 weeks)
Headache Frequency
Headache Frequency self-reported by a headache diary
Time frame: follow-up (20 weeks)
Duration of headache episodes
Duration of headache episodes self-reported by a headache diary
Time frame: post-intervention (8 weeks)
Duration of headache episodes
Duration of headache episodes self-reported by a headache diary
Time frame: follow-up (20 weeks)
Pain Intensity
Numeric rating scale
Time frame: post-intervention (8 weeks)
Pain Intensity
Numeric rating scale (NRS)
Time frame: follow-up (20 weeks)
Pain medication use
Pain medication use self-reported by a headache diary
Time frame: post-intervention (8 weeks)
Pain medication use
Pain medication use self-reported by a headache diary
Time frame: follow-up (20 weeks)
Headache related disability
Headche Impact Test 6 (HIT-6)
Time frame: post-intervention (8 weeks)
Headache related disability
Headche Impact Test 6 (HIT-6)
Time frame: follow-up (20 weeks)
Health-related quality of life
SF-36 questionaire
Time frame: post-intervention (8 weeks)
Health-related quality of life
SF-36 questionaire
Time frame: follow-up (20 weeks)
Anxiety
Depression and Anxiety scale (DAAS)
Time frame: post-intervention (8 weeks)
Anxiety
Depression and Anxiety scale (DAAS)
Time frame: follow-up (20 weeks)
Stress
Depression and Anxiety scale (DAAS)
Time frame: post-intervention (8 weeks)
Stress
Depression and Anxiety scale (DAAS)
Time frame: follow-up (20 weeks)
Pain catastrophizing
Pain catastrophizing scale (PCS)
Time frame: post-intervention (8 weeks)
Pain catastrophizing
Pain catastrophizing scale (PCS)
Time frame: follow-up (20 weeks)
Pain acceptance
Chronic pain acceptance questionaire (CPAQ)
Time frame: post-intervention (8 weeks)
Pain acceptance
Chronic pain acceptance questionaire (CPAQ)
Time frame: follow-up (20 weeks)
Mindfulness
Mindfulness Attention and Awerness scale (MAAS)
Time frame: post-intervention (8 weeks)
Mindfulness
Mindfulness Attention and Awerness scale (MAAS)
Time frame: follow-up (20 weeks)
Body Awareness
Body Awareness questionaire (BAQ)
Time frame: post-intervention (8 weeks)
Body Awareness
Body Awareness questionaire (BAQ)
Time frame: follow-up (20 weeks)
Safety
Adverse events
Time frame: post-intervention (8 weeks)
Safety
Adverse events
Time frame: follow-up (20 weeks)
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