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Yoga Therapy for Chronic Tension-Type Headache

Sponsor
NMP Medical Research Institute (Other)
Overall Status
Completed
CT.gov ID
NCT03862638
Collaborator
Yog-Kulam (Other), Department of Zoology, University of Rajasthan, India (Other)
68
Enrollment
1
Location
1
Arm
33.2
Actual Duration (Months)
2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Yoga Therapy
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
68 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Yoga Therapy for Chronic Tension-Type Headache: An Evaluation Study
Actual Study Start Date :
Apr 10, 2010
Actual Primary Completion Date :
Dec 12, 2012
Actual Study Completion Date :
Jan 15, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: Yoga Therapy

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. The number of days with headache [Change from baseline to 12-week of intervention]

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

    Secondary Outcome Measures

    1. The medication intake [Change from baseline to 12 week of intervention]

      Medication score per month were recorded through headache diaries

    2. Intensity of Pan [Change from baseline to12 week of intervention]

      Each headache intensity was measure through 0-10 scale; 0 was no pain and 10 was worst pain

    3. Duration of Pain [Change from baseline to12 week of intervention]

      Duration of each headache was measured through headache diaries

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 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.

    Exclusion Criteria:

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 NMP Medical Research Institue Jaipur Rajasthan India 302019

    Sponsors and Collaborators

    • NMP Medical Research Institute
    • Yog-Kulam
    • Department of Zoology, University of Rajasthan, India

    Investigators

    • Principal Investigator: Neha Sharma, PhD, Yog-Kulam
    • Study Director: PJ John, PhD, Deaprtment of Zoology, University of Rajasthan
    • Study Chair: Chandra M Sharma, DM, SMS Medical College and Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    NMP Medical Research Institute
    ClinicalTrials.gov Identifier:
    NCT03862638
    Other Study ID Numbers:
    • NMP/23891
    First Posted:
    Mar 5, 2019
    Last Update Posted:
    Mar 5, 2019
    Last Verified:
    Mar 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Tension-Type Headache
    Headache

    Study Results

    No Results Posted as of Mar 5, 2019