Tension-type HeadacheNCT02170259
Manual Therapy for Tension Headache With Psychological Disorders
A study testing The suboccipital technique, The articulatory technique and Combined treatment in people with Tension-type Headache, run by University of Valencia at 1 site in Spain.
Trial summary
Introduction. Tension-type headache is a highly prevalent disorder with a significant socio-economic impact, affecting psychological aspects. This study aims to assess aspects pertaining to anxiety, depression, headache frequency and pain intensity. Subjects and methods. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tension-type Headache
- What is being tested?
- The suboccipital technique, The articulatory technique and Combined treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2012to Jan 2016
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients participating in this study had been diagnosed in primary healthcare centers with frequent episodic tension-type headache (ETTH) or chronic tension-type headache (CTTH) as described by the International Headache Society (IHS). Participants presented pericranial tenderness evolving over a period greater than six months and all were pharmacologically stable.
Who cannot join
- Exclusion criteria covered patients with secondary headache suffering from photophobia or phonophobia, nausea or vomiting, cases of headache aggravated by head movements, musculoskeletal disorders, previous neck trauma, vertigo, dizziness, arterial hypertension, arthritis or advanced degenerative osteoarthritis, patients with heart devices, excessive emotional tension, neurological disorders, radiological alterations, pregnancy and a positive vertebral artery test.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Manual Therapy for the Treatment of Tension-type Headache in Patients With Anxiety and Depressive Disorders. A Randomized Controlled Clinical Trial
Introduction. Tension-type headache is a highly prevalent disorder with a significant socio-economic impact, affecting psychological aspects. This study aims to assess aspects pertaining to anxiety, depression, headache frequency and pain intensity.
Subjects and methods. A clinical trial was conducted on 84 participants suffering from tension-type headache, divided into 4 groups, the mean age being 39.76 years (SD 11.38). The first group received suboccipital soft tissue treatment (ST); the second group was treated with articulatory technique (AT); the third group was applied a combination of both techniques (ST and AT) and a forth group which served as control group. Treatment sessions were administered during four weeks, with a post-treatment assessment, and follow-up after one month. The investigators conducted Repeated measures Analysis of Covariance (RM-MANCOVA) to evaluate the effect of treatment on between and within-subject conditions and their interaction on reported depression, anxiety, and headache pain frequency and intensity.
- Conditions
- Tension-type Headache
- Being tested
- The suboccipital technique, The articulatory technique, Combined treatment
- Keywords
- Tension-type headache, Depression, Anxiety, Manual therapy, Spinal manipulation, Patients diagnosed with tension-type headache
- Medical subject headings
- Tension-Type Headache, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The suboccipital techniqueOther
The suboccipital technique (ST) aims to release the spasm of the muscles affected in tension-type headaches and in general of suboccipital soft tissues, as they are responsible for the mobility dysfunction of the occiput-atlas-axis joint; this releases the facial restriction of this region. Patients lied on the stretcher, in supine position, with their occiput resting against the physiotherapist's hands. Fingertips slide until contacting the posterior arch of atlas so that it "hangs" from the fingers. A deep and progressive pressure is applied, perpendicularly to muscle fibers, until the therapist perceives that muscle tone decreases. Approximate duration of ST is 10 minutes and it is performed with patients' eyes closed because of the connection between craniocervical muscle tone and eye movements
The articulatory techniqueOther
The articulatory technique (AT) was administered to correct and restore the mobility of joints between occiput, atlas and axis - correcting a global joint dysfunction. This technique was performed in supine position, in the same manner as the preceding technique, bilaterally and in two phases. First, a gentle head decompression is applied, followed by small circumduction searching for the joint barrier in rotation through selective tension. Second, the manipulation is performed by a cranial rotation towards the same side as the circumduction and around a vertical axis passing through the axis, without cervical flexion or extension and very little bending
Combined treatmentOther
Combined treatment (ST and AT). Combination treatment consisted of the application of the two preceding treatments in the same sequence: first, treatment with ST and then AT, thereafter maintaining the resting position for five minutes
| Study group | Role | What they receive |
|---|---|---|
| suboccipital technique | Experimental | The suboccipital technique (ST) aims to release the spasm of the muscles affected in tension-type headaches and in general of suboccipital soft tissues, as they are responsible for the mobility dysfunction of the occiput-atlas-axis joint; this releases the facial restriction of this region. Receives: Other: The suboccipital technique |
| The articulatory technique | Experimental | - The articulatory technique (AT) was administered to correct and restore the mobility of joints between occiput, atlas and axis - correcting a global joint dysfunction. This technique was performed in supine position, in the same manner as the preceding technique, bilaterally and in two phases. Receives: Other: The articulatory technique |
| Combined treatment | Experimental | Combined treatment (ST and AT). Combination treatment consisted of the application of the two preceding treatments in the same sequence: first, treatment with ST and then AT. Receives: Other: Combined treatment |
| Control group | No intervention | Control group. The control group was not applied a treatment technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Frequency of TTH at week 4 and at week 8
During the study, all subjects completed a weekly register of headaches.
Measured: Baseline, week 4, and week 8
Change from baseline in Intensity of TTH at week 4 and at week 8
During the study, all subjects completed a weekly register of headaches, recording on a daily basis their intensity, using the Visual Analogue Scale (VAS), which measures pain intensity in a 0-10 scale (0=no pain, 10=the most severe pain).
Measured: Basline, week 4 and week 8
Secondary outcomes (2)
Anxiety
Anxiety was assessed with the State-Trait Anxiety Inventory (STAI-SA and STAI-TA). Scores range from 0 to a maximum of 60 points; scoring above the 50th percentile indicates the presence of anxiety. For men, this percentile correlates with a score of 19 points, both for STAI-state and STAI-trait. For women, scores over 21 for STAI-state and 24 for STAI-trait determine this level.
Measured: All patients were assessed under the same conditions before the treatment, after the treatment (at 4 weeks), and at follow-up (after 8 weeks).
Depression
Depression, assessed with the Beck Depression Inventory (BDI) , which consists of 21 items with 4 possible answers each; it is intended to assess the severity of depression. It was adapted into Spanish and validated by Conde and Useros, showing very good
Measured: All patients were assessed under the same conditions before the treatment, after the treatment (at 4 weeks), and at follow-up (after 8 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2014 (estimated)
- Study startJan 2012
- Primary completionDec 2012
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tension-type HeadacheStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe 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
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GEMMA V ESPÍ LÓPEZ, PhD, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02170259
- Sponsor's protocol ID
- UVtensiontype
- Status last verified
- May 2016
- First submitted
- 3 Jun 2014
- Last updated
- 9 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Penacoba-Puente C, Fernandez-de-Las-Penas C, Gonzalez-Gutierrez JL, Miangolarra-Page JC, Pareja JA. Interaction between anxiety, depression, quality of life and clinical parameters in chronic tension-type headache. Eur J Pain. 2008 Oct;12(7):886-94. doi: 10.1016/j.ejpain.2007.12.016. Epub 2008 Mar 10.
PubMed 18331805
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Manual Therapy for the Treatment of Tension-type Headache in Patients With Anxiety and Depressive Disorders. A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT02170259
- Acronym / sponsor ID
- UVtensiontype
- Conditions
- Tension-type Headache
- Keywords
- Tension-type headache, Depression, Anxiety, Manual therapy, Spinal manipulation, Patients diagnosed with tension-type headache
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 23 Jun 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.
Introduction. Tension-type headache is a highly prevalent disorder with a significant socio-economic impact, affecting psychological aspects. This study aims to assess aspects pertaining to anxiety, depression, headache frequency and pain intensity.
Subjects and methods. A clinical trial was conducted on 84 participants suffering from tension-type headache, divided into 4 groups, the mean age being 39.76 years (SD 11.38). The first group received suboccipital soft tissue treatment (ST); the second group was treated with articulatory technique (AT); the third group was applied a combination of both techniques (ST and AT) and a forth group which served as control group. Treatment sessions were administered during four weeks, with a post-treatment assessment, and follow-up after one month. The investigators conducted Repeated measures Analysis of Covariance (RM-MANCOVA) to evaluate the effect of treatment on between and within-subject conditions and their interaction on reported depression, anxiety, and headache pain frequency and intensity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| suboccipital technique | Experimental | Other: The suboccipital techniqueThe suboccipital technique (ST) aims to release the spasm of the muscles affected in tension-type headaches and in general of suboccipital soft tissues, as they are responsible for the mobility dysfunction of the occiput-atlas-axis joint; this releases the facial restriction of this region. |
| The articulatory technique | Experimental | Other: The articulatory technique- The articulatory technique (AT) was administered to correct and restore the mobility of joints between occiput, atlas and axis - correcting a global joint dysfunction. This technique was performed in supine position, in the same manner as the preceding technique, bilaterally and in two phases. |
| Combined treatment | Experimental | Other: Combined treatmentCombined treatment (ST and AT). Combination treatment consisted of the application of the two preceding treatments in the same sequence: first, treatment with ST and then AT. |
| Control group | No intervention | –Control group. The control group was not applied a treatment technique |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients participating in this study had been diagnosed in primary healthcare centers with frequent episodic tension-type headache (ETTH) or chronic tension-type headache (CTTH) as described by the International Headache Society (IHS). Participants presented pericranial tenderness evolving over a period greater than six months and all were pharmacologically stable.
Key exclusion criteria (1 listed)
- Exclusion criteria covered patients with secondary headache suffering from photophobia or phonophobia, nausea or vomiting, cases of headache aggravated by head movements, musculoskeletal disorders, previous neck trauma, vertigo, dizziness, arterial hypertension, arthritis or advanced degenerative osteoarthritis, patients with heart devices, excessive emotional tension, neurological disorders, radiological alterations, pregnancy and a positive vertebral artery test.
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 |
|---|---|---|
| The suboccipital techniqueThe suboccipital technique (ST) aims to release the spasm of the muscles affected in tension-type headaches and in general of suboccipital soft tissues, as they are responsible for the mobility dysfunction of the occiput-atlas-axis joint; this releases the facial restriction of this region. Patients lied on the stretcher, in supine position, with their occiput resting against the physiotherapist's hands. Fingertips slide until contacting the posterior arch of atlas so that it "hangs" from the fingers. A deep and progressive pressure is applied, perpendicularly to muscle fibers, until the therapist perceives that muscle tone decreases. Approximate duration of ST is 10 minutes and it is performed with patients' eyes closed because of the connection between craniocervical muscle tone and eye movements | Other | suboccipital technique |
| The articulatory techniqueThe articulatory technique (AT) was administered to correct and restore the mobility of joints between occiput, atlas and axis - correcting a global joint dysfunction. This technique was performed in supine position, in the same manner as the preceding technique, bilaterally and in two phases. First, a gentle head decompression is applied, followed by small circumduction searching for the joint barrier in rotation through selective tension. Second, the manipulation is performed by a cranial rotation towards the same side as the circumduction and around a vertical axis passing through the axis, without cervical flexion or extension and very little bending | Other | The articulatory technique |
| Combined treatmentCombined treatment (ST and AT). Combination treatment consisted of the application of the two preceding treatments in the same sequence: first, treatment with ST and then AT, thereafter maintaining the resting position for five minutes | Other | Combined treatment |
Primary outcome
Change from baseline in Frequency of TTH at week 4 and at week 8
Time frame: Baseline, week 4, and week 8
During the study, all subjects completed a weekly register of headaches.
Change from baseline in Intensity of TTH at week 4 and at week 8
Time frame: Basline, week 4 and week 8
During the study, all subjects completed a weekly register of headaches, recording on a daily basis their intensity, using the Visual Analogue Scale (VAS), which measures pain intensity in a 0-10 scale (0=no pain, 10=the most severe pain).
2 secondary outcomes
Anxiety
Time frame: All patients were assessed under the same conditions before the treatment, after the treatment (at 4 weeks), and at follow-up (after 8 weeks).
Depression
Time frame: All patients were assessed under the same conditions before the treatment, after the treatment (at 4 weeks), and at follow-up (after 8 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 9 May 2016.
- Results publication: PubMed 18331805Penacoba-Puente C, Fernandez-de-Las-Penas C, Gonzalez-Gutierrez JL, Miangolarra-Page JC, Pareja JA. Interaction between anxiety, depression, quality of life and clinical parameters in chronic tension-type headache. Eur J Pain. 2008 Oct;12(7):886-94. doi: 10.1016/j.ejpain.2007.12.016. Epub 2008 Mar 10.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The suboccipital technique, The articulatory technique and Combined treatment in people with Tension-type Headache, run by University of Valencia at 1 site in Spain.
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 1 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 9 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Change from baseline in Frequency of TTH at week 4 and at week 8 (time frame: Baseline, week 4, and week 8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02170259, which also lists 1 linked publication.
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 9 May 2016.