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Clinical Trials/NCT04867967
NCT04867967
Completed
Not Applicable

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

Universität Duisburg-Essen1 site in 1 country72 target enrollmentFebruary 1, 2019
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ConditionsTension-Type Headache

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Tension-Type Headache
Sponsor
Universität Duisburg-Essen
Enrollment
72
Locations
1
Primary Endpoint
Headache Frequency
Status
Completed
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 1, 2019
End Date
December 30, 2021
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Holger Cramer

PD Dr. rer. medic

Universität Duisburg-Essen

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
  • •Pregnancy
  • •actual in a yoga or MBSR class

Outcomes

Primary Outcomes

Headache Frequency

Time Frame: post-intervention (8 weeks)

Headache Frequency self-reported by a headache diary

Secondary Outcomes

  • Stress(follow-up (20 weeks))
  • Pain catastrophizing(follow-up (20 weeks))
  • Safety(follow-up (20 weeks))
  • Pain medication use(follow-up (20 weeks))
  • Pain Intensity(follow-up (20 weeks))
  • Duration of headache episodes(follow-up (20 weeks))
  • Pain acceptance(follow-up (20 weeks))
  • Mindfulness(follow-up (20 weeks))
  • Headache Frequency(follow-up (20 weeks))
  • Body Awareness(follow-up (20 weeks))
  • Headache related disability(follow-up (20 weeks))
  • Health-related quality of life(follow-up (20 weeks))
  • Anxiety(follow-up (20 weeks))

Study Sites (1)

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