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

Tension-Type Headache Clinical Trial

— ERTTHU  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02264340
• Other study ID #: F(EFP)-003/2010
• Status: Completed
• Phase: N/A
• First received: October 8, 2014
• Last updated: October 14, 2014
• Start date: September 2010
• Est. completion date: March 2011

Study information

• Verified date: October 2014
• Source: Universidad Complutense de Madrid
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: March 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 25 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Headache
• Tension-Type Headache

Intervention

Behavioral:
• Relaxation technique Autogenic Training
Autogenic Training
• Combined treatment Autogenic Training + Cervical exercises and postural correction
Autogenic Training + Cervical exercises and postural correction

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Complutense de Madrid

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency	Days with headache, during 4 weeks	4 weeks	No
Secondary	Intensity	Pain intensity (VAS: 1-10)	4 weeks	No
Secondary	Duration	Hours a day with headache	4 weeks	No
Secondary	Medication	Days in which person takes drugs for pain, during 4 weeks	4 weeks	No