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CompletedNCT02264340ERTTHUUpdated Oct 15, 2014

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

An interventional study of Relaxation technique Autogenic Training and Combined treatment Autogenic Training + Cervical exercises and postural correction in Tension-Type Headache, sponsored by Universidad Complutense de Madrid. Completed. Open to participants aged 18 Years to 25 Years. Per ClinicalTrials.gov, last updated 2014-10-15.

Sponsored by Universidad Complutense de Madrid · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
152
Allocation
Randomized
Ages
18 Years to 25 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Tension-Type Headache

Keywords

  • Tension-type headache
  • relaxation techniques
  • physiotherapy
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In context

Tension-Type Headache

144 studies on the registry are indexed under Tension-Type Headache; 41 are open to participants now.

This study's enrollment of 152 is above the median of 60 across 109 interventional studies indexed under Tension-Type Headache.

Browse Tension-Type Headache studies →

Lead sponsor

Universidad Complutense de Madrid is the lead sponsor of 200 studies on the registry; 60 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 25 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
152 participants (actual)

Study arms

  • Active comparator
    Control

    Relaxation technique

    Behavioral: Relaxation technique Autogenic Training

  • Experimental
    Experimental

    Combined treatment

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

Interventions

  • BehavioralRelaxation technique Autogenic Training

    Autogenic Training

  • BehavioralCombined treatment Autogenic Training + Cervical exercises and postural correction

    Autogenic Training + Cervical exercises and postural correction

06

What researchers measure

Primary outcomes

  1. Frequency

    Days with headache, during 4 weeks

    Time frame: 4 weeks

Secondary outcomes

  1. Intensity

    Pain intensity (VAS: 1-10)

    Time frame: 4 weeks

  2. Duration

    Hours a day with headache

    Time frame: 4 weeks

  3. Medication

    Days in which person takes drugs for pain, during 4 weeks

    Time frame: 4 weeks

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Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 15, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02264340
Lead sponsor
Universidad Complutense de Madrid
Responsible party
Ángela Álvarez Melcón (Physiotherapist (Doctor), Universidad Complutense de Madrid) — Principal investigator
First posted
Oct 15, 2014
Start date
Sep 2010
Primary completion
Dec 2010
Completion
Mar 2011
Last update
Oct 15, 2014

Study contacts

Ángela Álvarez Melcón, Doctor
principal investigator · Universidad Complutense de Madrid

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2014. You cannot join it, but the record below documents what was studied.

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