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

NCT02264340 | Completed

• 1 other identifier: F(EFP)-003/2010
• Study Type: interventional
• Target: 152
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Tension-Type Headache

Keywords

Tension-type headache; relaxation techniques; physiotherapy

Outcome Measures

Primary Outcomes (1)

• Frequency

  Days with headache, during 4 weeks

  4 weeks

Secondary Outcomes (3)

• Intensity

  4 weeks

• Duration

  4 weeks

• Medication

  4 weeks

Study Arms (2)

Control

ACTIVE COMPARATOR

Relaxation technique

Behavioral: Relaxation technique Autogenic Training

Experimental

EXPERIMENTAL

Combined treatment

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

Interventions

Relaxation technique Autogenic Training BEHAVIORAL

Autogenic Training

Control

Combined treatment Autogenic Training + Cervical exercises and postural correction BEHAVIORAL

Autogenic Training + Cervical exercises and postural correction

Experimental

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Complutense de Madrid: lead

MeSH Terms

Conditions

Tension-Type Headache

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Ángela Álvarez Melcón, Doctor

  Universidad Complutense de Madrid

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist (Doctor)

Study Record Dates

• First Submitted: October 8, 2014
• First Posted: October 15, 2014
• Study Start: September 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: March 1, 2011
• Last Updated: October 15, 2014

Record last verified: 2014-10