Clinical trial NCT04867967: Yoga and MBSR for TTH
Official title: Yoga and Mindfulnes-based-stress-reduction for Patients With Tension-type Headache
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tension-Type Headache
Keywords: Tension-Type Headache
Yoga
Mindfulness-based stress reduction
Lead sponsor: Universität Duisburg-Essen
Sponsor class: OTHER
Collaborators: name: Eden Stiftung
First posted: 2021-04-30
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Headache Frequency
timeFrame: post-intervention (8 weeks)
Secondary outcomes:
measure: Headache Frequency
timeFrame: follow-up (20 weeks)
measure: Duration of headache episodes
timeFrame: post-intervention (8 weeks)
measure: Duration of headache episodes
timeFrame: follow-up (20 weeks)
measure: Pain Intensity
timeFrame: post-intervention (8 weeks)
measure: Pain Intensity
timeFrame: follow-up (20 weeks)
measure: Pain medication use
timeFrame: post-intervention (8 weeks)
measure: Pain medication use
timeFrame: follow-up (20 weeks)
measure: Headache related disability
timeFrame: post-intervention (8 weeks)
measure: Headache related disability
timeFrame: follow-up (20 weeks)
measure: Health-related quality of life
timeFrame: post-intervention (8 weeks)
measure: Health-related quality of life
timeFrame: follow-up (20 weeks)
measure: Anxiety
timeFrame: post-intervention (8 weeks)
measure: Anxiety
timeFrame: follow-up (20 weeks)
measure: Stress
timeFrame: post-intervention (8 weeks)
measure: Stress
timeFrame: follow-up (20 weeks)
measure: Pain catastrophizing
timeFrame: post-intervention (8 weeks)
measure: Pain catastrophizing
timeFrame: follow-up (20 weeks)
measure: Pain acceptance
timeFrame: post-intervention (8 weeks)
measure: Pain acceptance
timeFrame: follow-up (20 weeks)
measure: Mindfulness
timeFrame: post-intervention (8 weeks)
measure: Mindfulness
timeFrame: follow-up (20 weeks)
measure: Body Awareness
timeFrame: post-intervention (8 weeks)
measure: Body Awareness
timeFrame: follow-up (20 weeks)
measure: Safety
timeFrame: post-intervention (8 weeks)
measure: Safety
timeFrame: follow-up (20 weeks)
Other outcomes:
Locations:
city: Essen
country: Germany
facility: Evang. Kliniken Essen-Mitte
state: Northrhine-Westphalia
Study officials:
affiliation: University of Duisburg-Essen, Faculty of Medicine
name: Gustav Dobos, MD
role: STUDY_CHAIR
References: