NCT03862638

Brief Summary

Chronic tension headache represents a considerable social burden in terms of both costs to the health services and also the costs of lost productivity. Episodic tension-type headache can be treated with rest and analgesics, while chronic tension-type headache demands a more fundamental treatment. Effectiveness of yoga therapy in the management of chronic tension type headache is limited. In this study, yoga therapy was used to explore its effect on chronic tension-type headache.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 10, 2010

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2013

Completed
6.1 years until next milestone

First Submitted

Initial submission to the registry

February 28, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 5, 2019

Completed
Last Updated

March 5, 2019

Status Verified

March 1, 2019

Enrollment Period

2.7 years

First QC Date

February 28, 2019

Last Update Submit

March 2, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • The number of days with headache

    Number of days with headache every four weeks were assessed through headache diaries

    Change from baseline to 12-week of intervention

Secondary Outcomes (3)

  • The medication intake

    Change from baseline to 12 week of intervention

  • Intensity of Pan

    Change from baseline to12 week of intervention

  • Duration of Pain

    Change from baseline to12 week of intervention

Study Arms (1)

Yoga Therapy

EXPERIMENTAL

Yoga therapy session lasted for 60 minutes consisting physical posture, Breath work, Relaxation, guided meditation, chants and combination techniques for groups sessions.

Other: Yoga Therapy

Interventions

Yoga therapy is therapeutic application of yoga, specifically designed to treat the condition using physical posture, breathing exercises, guided relaxation and meditation.

Also known as: Yoga
Yoga Therapy

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Meeting the diagnostic criteria of CTTH in the international classification of headache disorders, 3rd edition (beta version) (ICHD-III beta);
  • Aged 18-55 years;
  • Having the ability of understanding and completing the headache dairy;
  • Provide written informed consent.

You may not qualify if:

  • No headache during the pervious 3 months;
  • Taking any prophylactic medication during the previous one month;
  • Secondary headache or any systematic cause
  • Having serious conditions of the heart, liver, kidney or other organs;
  • In pregnancy or lactation, or planning to be pregnant in 6 months;
  • Drug and Substance abuse
  • Diagnosed psychiatric condition
  • Taking any other complementary and alternative medicines
  • Practicing yoga of any kind in last three months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NMP Medical Research Institue

Jaipur, Rajasthan, 302019, India

Location

MeSH Terms

Interventions

Yoga

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Neha Sharma, PhD

    Yog-Kulam

    PRINCIPAL INVESTIGATOR
  • PJ John, PhD

    Deaprtment of Zoology, University of Rajasthan

    STUDY DIRECTOR
  • Chandra M Sharma, DM

    SMS Medical College and Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2019

First Posted

March 5, 2019

Study Start

April 10, 2010

Primary Completion

December 12, 2012

Study Completion

January 15, 2013

Last Updated

March 5, 2019

Record last verified: 2019-03

Locations