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Effects of Exercise and Relaxation Techniques on Tension Headache Pain Parameters of University Students (ERTTHU)

Primary Purpose

Tension-Type Headache

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Relaxation technique Autogenic Training
Combined treatment Autogenic Training + Cervical exercises and postural correction
Sponsored by
Universidad Complutense de Madrid
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tension-Type Headache focused on measuring Tension-type headache, relaxation techniques, physiotherapy

Eligibility Criteria

18 Years - 25 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • College students of Complutense University of Madrid, diagnosed with frequent episodic or chronic tension-type headache (according to the criteria of International Headache Society (IHS)).

Exclusion Criteria:

  • Cases with other headaches
  • Students with excessive state anxiety and / or trait anxiety (≥ 85 percentile, State-Trait Anxiety Inventory )
  • Students that had received treatment for tension headache, based on physical exercise or relaxation techniques, in the last 6 months.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Control

    Experimental

    Arm Description

    Relaxation technique

    Combined treatment

    Outcomes

    Primary Outcome Measures

    Frequency
    Days with headache, during 4 weeks

    Secondary Outcome Measures

    Intensity
    Pain intensity (VAS: 1-10)
    Duration
    Hours a day with headache
    Medication
    Days in which person takes drugs for pain, during 4 weeks

    Full Information

    First Posted
    October 8, 2014
    Last Updated
    October 14, 2014
    Sponsor
    Universidad Complutense de Madrid
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02264340
    Brief Title
    Effects of Exercise and Relaxation Techniques on Tension Headache Pain Parameters of University Students
    Acronym
    ERTTHU
    Official Title
    EFFECTS OF EXERCISE AND RELAXATION TECHNIQUES ON TENSION-TYPE HEADACHE PAIN PARAMETERS OF UNIVERSITY STUDENTS; A RANDOMIZED AND CONTROLLED CLINICAL TRIAL
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2010 (undefined)
    Primary Completion Date
    December 2010 (Actual)
    Study Completion Date
    March 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universidad Complutense de Madrid

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Tension headache is a common disabling disease and a worldwide public health problem. This research tries to demonstrate the efficacy of physical therapy, based on cervical training and postural self-correction instructions, which aims to increase the positive results obtained from traditional relaxation techniques (Schultz Autogenic Training). University students are selected, because headaches are very common in this sector of the population. The design is a non-pharmacological randomized controlled trial, with blinded evaluation of the response variables. The investigators compare two independent samples. One of them receives an only treatment (Autogenic Training) and the other group receives a combined program (Autogenic Training + specific cervical exercises and postural correction). Pain parameters (frequency, intensity and duration) and drug consumption are measured before treatment, and then, at 4 weeks and 3 months, to value the results.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Tension-Type Headache
    Keywords
    Tension-type headache, relaxation techniques, physiotherapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    152 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Control
    Arm Type
    Active Comparator
    Arm Description
    Relaxation technique
    Arm Title
    Experimental
    Arm Type
    Experimental
    Arm Description
    Combined treatment
    Intervention Type
    Behavioral
    Intervention Name(s)
    Relaxation technique Autogenic Training
    Intervention Description
    Autogenic Training
    Intervention Type
    Behavioral
    Intervention Name(s)
    Combined treatment Autogenic Training + Cervical exercises and postural correction
    Intervention Description
    Autogenic Training + Cervical exercises and postural correction
    Primary Outcome Measure Information:
    Title
    Frequency
    Description
    Days with headache, during 4 weeks
    Time Frame
    4 weeks
    Secondary Outcome Measure Information:
    Title
    Intensity
    Description
    Pain intensity (VAS: 1-10)
    Time Frame
    4 weeks
    Title
    Duration
    Description
    Hours a day with headache
    Time Frame
    4 weeks
    Title
    Medication
    Description
    Days in which person takes drugs for pain, during 4 weeks
    Time Frame
    4 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    25 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: College students of Complutense University of Madrid, diagnosed with frequent episodic or chronic tension-type headache (according to the criteria of International Headache Society (IHS)). Exclusion Criteria: Cases with other headaches Students with excessive state anxiety and / or trait anxiety (≥ 85 percentile, State-Trait Anxiety Inventory ) Students that had received treatment for tension headache, based on physical exercise or relaxation techniques, in the last 6 months.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ángela Álvarez Melcón, Doctor
    Organizational Affiliation
    Universidad Complutense de Madrid
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Effects of Exercise and Relaxation Techniques on Tension Headache Pain Parameters of University Students

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