Yoga and MBSR for TTH

Tension-Type Headache Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04867967
• Other study ID #: 17-7925 BO
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: December 30, 2021

Study information

• Verified date: April 2021
• Source: Universität Duisburg-Essen
• Contact: Dennis Anheyer, MA & BSc
• Phone: +4920117425550
• Email: d.anheyer[@]kem-med.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: December 30, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Headache
• Tension-Type Headache

Intervention

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

Locations

Country	Name	City	State
Germany	Evang. Kliniken Essen-Mitte	Essen	Northrhine-Westphalia

Sponsors (2)

Lead Sponsor	Collaborator
Universität Duisburg-Essen	Eden Stiftung

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Headache Frequency	Headache Frequency self-reported by a headache diary	post-intervention (8 weeks)
Secondary	Headache Frequency	Headache Frequency self-reported by a headache diary	follow-up (20 weeks)
Secondary	Duration of headache episodes	Duration of headache episodes self-reported by a headache diary	post-intervention (8 weeks)
Secondary	Duration of headache episodes	Duration of headache episodes self-reported by a headache diary	follow-up (20 weeks)
Secondary	Pain Intensity	Numeric rating scale	post-intervention (8 weeks)
Secondary	Pain Intensity	Numeric rating scale (NRS)	follow-up (20 weeks)
Secondary	Pain medication use	Pain medication use self-reported by a headache diary	post-intervention (8 weeks)
Secondary	Pain medication use	Pain medication use self-reported by a headache diary	follow-up (20 weeks)
Secondary	Headache related disability	Headche Impact Test 6 (HIT-6)	post-intervention (8 weeks)
Secondary	Headache related disability	Headche Impact Test 6 (HIT-6)	follow-up (20 weeks)
Secondary	Health-related quality of life	SF-36 questionaire	post-intervention (8 weeks)
Secondary	Health-related quality of life	SF-36 questionaire	follow-up (20 weeks)
Secondary	Anxiety	Depression and Anxiety scale (DAAS)	post-intervention (8 weeks)
Secondary	Anxiety	Depression and Anxiety scale (DAAS)	follow-up (20 weeks)
Secondary	Stress	Depression and Anxiety scale (DAAS)	post-intervention (8 weeks)
Secondary	Stress	Depression and Anxiety scale (DAAS)	follow-up (20 weeks)
Secondary	Pain catastrophizing	Pain catastrophizing scale (PCS)	post-intervention (8 weeks)
Secondary	Pain catastrophizing	Pain catastrophizing scale (PCS)	follow-up (20 weeks)
Secondary	Pain acceptance	Chronic pain acceptance questionaire (CPAQ)	post-intervention (8 weeks)
Secondary	Pain acceptance	Chronic pain acceptance questionaire (CPAQ)	follow-up (20 weeks)
Secondary	Mindfulness	Mindfulness Attention and Awerness scale (MAAS)	post-intervention (8 weeks)
Secondary	Mindfulness	Mindfulness Attention and Awerness scale (MAAS)	follow-up (20 weeks)
Secondary	Body Awareness	Body Awareness questionaire (BAQ)	post-intervention (8 weeks)
Secondary	Body Awareness	Body Awareness questionaire (BAQ)	follow-up (20 weeks)
Secondary	Safety	Adverse events	post-intervention (8 weeks)
Secondary	Safety	Adverse events	follow-up (20 weeks)