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

October 14, 2014 updated by: Ángela Álvarez Melcón, Universidad Complutense de Madrid

EFFECTS OF EXERCISE AND RELAXATION TECHNIQUES ON TENSION-TYPE HEADACHE PAIN PARAMETERS OF UNIVERSITY STUDENTS; A RANDOMIZED AND CONTROLLED CLINICAL TRIAL

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

152

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 25 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Control
Relaxation technique
Behavioral: Relaxation technique Autogenic Training
Autogenic Training
EXPERIMENTAL: Experimental
Combined treatment
Behavioral: Combined treatment Autogenic Training + Cervical exercises and postural correction
Autogenic Training + Cervical exercises and postural correction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency
Time Frame: 4 weeks
Days with headache, during 4 weeks
4 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Complutense de Madrid

Investigators

  • Principal Investigator: Ángela Álvarez Melcón, Doctor, Universidad Complutense de Madrid

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (ACTUAL)

December 1, 2010

Study Completion (ACTUAL)

March 1, 2011

Study Registration Dates

First Submitted

October 8, 2014

First Submitted That Met QC Criteria

October 14, 2014

First Posted (ESTIMATE)

October 15, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

October 15, 2014

Last Update Submitted That Met QC Criteria

October 14, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F(EFP)-003/2010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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