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
About this trial
This is an interventional treatment trial for Tension-Type Headache focused on measuring Tension-type headache, relaxation techniques, physiotherapy
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.
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
NCT ID
NCT02264340
First Posted
October 8, 2014
Last Updated
October 14, 2014
Sponsor
Universidad Complutense de Madrid
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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