Tension-Type HeadacheERTTHUNCT02264340
Effects of Exercise and Relaxation Techniques on Tension Headache Pain Parameters of University Students
A study testing Relaxation technique Autogenic Training and Combined treatment Autogenic Training + Cervical exercises and postural correction in people with Tension-Type Headache, run by Universidad Complutense de Madrid.
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… Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Tension-Type Headache
- What is being tested?
- Relaxation technique Autogenic Training and Combined treatment Autogenic Training + Cervical exercises and postural correction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- No sites listed yet
- Study dates
- Sep 2010to Mar 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)).
Who cannot join
- 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.
About this study
Official title: 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.
- Conditions
- Tension-Type Headache
- Being tested
- Relaxation technique Autogenic Training, Combined treatment Autogenic Training + Cervical exercises and postural correction
- Keywords
- Tension-type headache, relaxation techniques, physiotherapy
- Medical subject headings
- Tension-Type Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relaxation technique Autogenic TrainingBehavioural
Autogenic Training
Combined treatment Autogenic Training + Cervical exercises and postural correctionBehavioural
Autogenic Training + Cervical exercises and postural correction
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Relaxation technique Receives: Behavioral: Relaxation technique Autogenic Training |
| Experimental | Experimental | Combined treatment Receives: Behavioral: Combined treatment Autogenic Training + Cervical exercises and postural correction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency
Days with headache, during 4 weeks
Measured: 4 weeks
Secondary outcomes (3)
Intensity
Pain intensity (VAS: 1-10)
Measured: 4 weeks
Duration
Hours a day with headache
Measured: 4 weeks
Medication
Days in which person takes drugs for pain, during 4 weeks
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2014 (estimated)
- Study startSep 2010
- Primary completionDec 2010
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tension-Type HeadacheStudies of the same condition, open and under way.
- More trials run by Universidad Complutense de MadridThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ángela Álvarez Melcón, Universidad Complutense de Madrid
- Investigators
- Ángela Álvarez Melcón, Doctor, Principal investigator, Universidad Complutense de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02264340
- Sponsor's protocol ID
- F(EFP)-003/2010
- Acronym
- ERTTHU
- Status last verified
- Oct 2014
- First submitted
- 8 Oct 2014
- Last updated
- 15 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECTS OF EXERCISE AND RELAXATION TECHNIQUES ON TENSION-TYPE HEADACHE PAIN PARAMETERS OF UNIVERSITY STUDENTS; A RANDOMIZED AND CONTROLLED CLINICAL TRIAL
- ClinicalTrials.gov ID
- NCT02264340
- Acronym / sponsor ID
- ERTTHU / F(EFP)-003/2010
- Conditions
- Tension-Type Headache
- Keywords
- Tension-type headache, relaxation techniques, physiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 15 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Behavioral: Relaxation technique Autogenic TrainingRelaxation technique |
| Experimental | Experimental | Behavioral: Combined treatment Autogenic Training + Cervical exercises and postural correctionCombined treatment |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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)).
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Relaxation technique Autogenic TrainingAutogenic Training | Behavioural | Control |
| Combined treatment Autogenic Training + Cervical exercises and postural correctionAutogenic Training + Cervical exercises and postural correction | Behavioural | Experimental |
Primary outcome
Frequency
Time frame: 4 weeks
Days with headache, during 4 weeks
3 secondary outcomes
Intensity
Time frame: 4 weeks
Duration
Time frame: 4 weeks
Medication
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ángela Álvarez Melcón, Doctor principal investigator
Universidad Complutense de Madrid
Questions about this trial
What is this clinical trial studying?
A study testing Relaxation technique Autogenic Training and Combined treatment Autogenic Training + Cervical exercises and postural correction in people with Tension-Type Headache, run by Universidad Complutense de Madrid.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2014.