Chronic Tension-Type HeadacheNCT05097300
Treatment of Tension Headache Using Soft Tissue Techniques VS Vagus Stimulation Techniques.
A study testing Suboccipital inhibition, Ischemic pressure and Passive stretching in people with Chronic Tension-Type Headache and Episodic Tension-Type Headache, run by Lucia Trullenque Espallargas at 2 sites in Spain.
Trial summary
A treatment based on manual therapy and vagus nerve stimulation is more effective than manual therapy only to reduce frequency, intensity and pressure pain threshold in patients with tension type headache. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Tension-Type Headache, Episodic Tension-Type Headache
- What is being tested?
- Suboccipital inhibition, Ischemic pressure and Passive stretching
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 2 sitesSpain
- Study dates
- 1 Nov 2021to 1 Dec 2021
- 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 diagnosed with episodic or chronic tension type headache
Who cannot join
- Pregnant women
- Patients who have received in the previous 3 months some type of treatment for headache
- Recent history of syncope or seizures
- Heart / cardiovascular disease
- Electrical or neurostimulation devices
- History of intracranial / carotid aneurysm or bleeding; brain tumors / lesions; significant head trauma.
- Change in prophylactic medication type or dose <1 month before the intervention
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Fisioterapia FIMA clinic
Madrid, 28029
Facultad de Enfermería y fisioterapia, Universidad Alcalá de Henares
Madrid, 28805
About this study
Official title: Tratamiento de la Cefalea Tensional Mediante técnicas de Tejido Blando VS técnicas de estimulación Del Vago.
A treatment based on manual therapy and vagus nerve stimulation is more effective than manual therapy only to reduce frequency, intensity and pressure pain threshold in patients with tension type headache.
Read the detailed description
Participants will be randomly assigned to two groups:
- Experimental group, to which soft tissue techniques and vagus nerve stimulation techniques will be applied.
- Control group, to which only soft tissue techniques are applied. Treatment will consist of four sessions, with an interval of seven days between them, for both study groups. Each session with a duration of 20 minutes for both groups.
In the control group, treatment using soft techniques will consist of the application of manual techniques that have already been shown to have some efficacy in other studies.
- Being tested
- Suboccipital inhibition, Ischemic pressure, Passive stretching, Diaphragmatic breathing exercice
- Keywords
- Tension type headache, Manual therapy, Vagus nerve stimulation
- 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.
Suboccipital inhibitionOther
The therapist will place his hands under the patient's head, making contact with the suboccipital muscles in the region of the posterior arch of the atlas, applying progressive and deep pressure. This pressure will be maintained for 10 minutes
Ischemic pressureOther
Pressures will be made on the temporal, superior trapezius, masseter and sternocleidomastoid muscles. Physical therapist will apply gradual sustained finger pressure to the muscle's active trigger points for 5-15 seconds. The therapist will begin with light firm pressure and gradually increase the pressure until the patient feels a "moderate but bearable" level of pain (corresponding to a level 7 on a pain scale of 1 to 10 levels where 1 indicates no pain and 10 is excruciating pain). Pressure will remain at this level until pain levels decrease to level 3. The therapist will repeat this procedure approximately 3-4 times over a 90 second period.
Passive stretchingOther
Passive stretches will be applied to each muscle 2 times for 30 seconds, they will be performed slowly at the rate of the patient's normal breathing and checking that no compensations appear.
Diaphragmatic breathing exerciceOther
To perform diaphragmatic breaths, there will first be an education on how to do them. The patient will lie supine, with the hips and knees semi-flexed. The therapist will ask you to place one hand on your chest and one on your abdomen. Successively, it will ask you to take a few deep breaths, inhaling through your nose for 2 seconds and exhaling through your mouth, with your lips pursed (almost closed) for 4 seconds, helping you to maintain the rhythm of your breath by counting out loud. The patient should note that during inspiration his hand on top of the chest does not rise (the chest remains still) and during expiration that his hand on top of the abdomen goes down (the abdomen sinks).
| Study group | Role | What they receive |
|---|---|---|
| Manual therapy and vagus nerve stimulation group | Experimental | Patients will recibe 4 sessions, each of the duration of 20 minutes. Manual therapy consist in: suboccipital inhibition (during 10 minutes) and ischemic pressure and passive stretching of three muscles (superior trapezius, temporal muscle and sternocleidomastoid muscle). Vagus nerve stimulation will be performed through a diaphragmatic breathing exercise, during 5 minutes, adding neural tension of median nerve. Receives: Other: Suboccipital inhibition; Other: Ischemic pressure; Other: Passive stretching; Other: Diaphragmatic breathing exercice |
| Manual therapy group | Active comparator | Patients will recibe 4 sessions, each of the duration of 20 minutes. Manual therapy consist in: suboccipital inhibition (during 10 minutes) and ischemic pressure and passive stretching of three muscles (superior trapezius, temporal muscle and sternocleidomastoid muscle). Receives: Other: Suboccipital inhibition; Other: Ischemic pressure; Other: Passive stretching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain intensity
The strength with which the participants subjectively feel their headache. It will be measured with the following degrees: mild, moderate or severe.
The Headache Disability Inventory will be used to measure pain intensity.
Measured: Day 1 (before the intervention), Day 28 (after the last intervention), Day 56 (4 weeks after the last intervention).
Secondary outcomes (4)
Change in Headache frequency
The number of headache episodes experienced by the participant in the 30-day time interval (once a month, more than once and less than 4 times a month, and once a week).
The Headache Disability Inventory will be used to measure headache frequency.
Measured: Day 1 (before the intervention), Day 28 (after the last intervention), Day 56 (4 weeks after the last intervention).
Change in Impact of pain
The impact of pain refers to how much pain affects the patient in the activities of his daily life.
It will be measured through 25 items of the Headache Disability Inventory.
Measured: Day 1 (before the intervention), Day 28 (after the last intervention), Day 56 (4 weeks after the last intervention).
Change in Pain threshold
Amount of pressure needed to change the patient's sensation from pressure to pain. It will be measured with an algometer, in Newton.
Measured: Day 1 (before the intervention), Day 28 (after the last intervention).
Change in Cervical Range of Motion
It will be measured in degrees, through a cervical goniometer. The patient will be placed in a sitting position. The movements to be measured will be: flexion, whose expected amplitude is 80º; extension with an expected amplitude of 80º; rotations with an expected amplitude of 80º and inclinations with an expected amplitude of 40º.
Measured: Day 1 (before the intervention), Day 28 (after the last intervention).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2021
- Study start1 Nov 2021 (estimated)
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Tension-Type HeadacheStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lucia Trullenque Espallargas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lucia Trullenque Espallargas, University of Alcala
- Investigators
- ALEJANDRO FERRAGUT, DOCTOR, Principal investigator, Universidad Alcalá de Henares
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05097300
- Sponsor's protocol ID
- CEIM/2021/1/017
- Status last verified
- Oct 2021
- First submitted
- 14 Sep 2021
- Last updated
- 28 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tratamiento de la Cefalea Tensional Mediante técnicas de Tejido Blando VS técnicas de estimulación Del Vago.
- ClinicalTrials.gov ID
- NCT05097300
- Acronym / sponsor ID
- CEIM/2021/1/017
- Keywords
- Tension type headache, Manual therapy, Vagus nerve stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Lucia Trullenque EspallargasUniversity, hospital or other
- Study start
- 1 Nov 2021 (estimated)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 28 Oct 2021 (actual)
- 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.
A treatment based on manual therapy and vagus nerve stimulation is more effective than manual therapy only to reduce frequency, intensity and pressure pain threshold in patients with tension type headache.
Detailed description
Participants will be randomly assigned to two groups:
- Experimental group, to which soft tissue techniques and vagus nerve stimulation techniques will be applied.
- Control group, to which only soft tissue techniques are applied. Treatment will consist of four sessions, with an interval of seven days between them, for both study groups. Each session with a duration of 20 minutes for both groups.
In the control group, treatment using soft techniques will consist of the application of manual techniques that have already been shown to have some efficacy in other studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual therapy and vagus nerve stimulation group | Experimental | Other: Suboccipital inhibition, Other: Ischemic pressure, Other: Passive stretching, Other: Diaphragmatic breathing exercicePatients will recibe 4 sessions, each of the duration of 20 minutes. Manual therapy consist in: suboccipital inhibition (during 10 minutes) and ischemic pressure and passive stretching of three muscles (superior trapezius, temporal muscle and sternocleidomastoid muscle). Vagus nerve stimulation will be performed through a diaphragmatic breathing exercise, during 5 minutes, adding neural tension of median nerve. |
| Manual therapy group | Active comparator | Other: Suboccipital inhibition, Other: Ischemic pressure, Other: Passive stretchingPatients will recibe 4 sessions, each of the duration of 20 minutes. Manual therapy consist in: suboccipital inhibition (during 10 minutes) and ischemic pressure and passive stretching of three muscles (superior trapezius, temporal muscle and sternocleidomastoid muscle). |
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 diagnosed with episodic or chronic tension type headache
Key exclusion criteria (7 listed)
- Pregnant women
- Patients who have received in the previous 3 months some type of treatment for headache
- Recent history of syncope or seizures
- Heart / cardiovascular disease
- Electrical or neurostimulation devices
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 |
|---|---|---|
| Suboccipital inhibitionThe therapist will place his hands under the patient's head, making contact with the suboccipital muscles in the region of the posterior arch of the atlas, applying progressive and deep pressure. This pressure will be maintained for 10 minutes | Other | Manual therapy and vagus nerve stimulation group, Manual therapy group |
| Ischemic pressurePressures will be made on the temporal, superior trapezius, masseter and sternocleidomastoid muscles. Physical therapist will apply gradual sustained finger pressure to the muscle's active trigger points for 5-15 seconds. The therapist will begin with light firm pressure and gradually increase the pressure until the patient feels a "moderate but bearable" level of pain (corresponding to a level 7 on a pain scale of 1 to 10 levels where 1 indicates no pain and 10 is excruciating pain). Pressure will remain at this level until pain levels decrease to level 3. The therapist will repeat this procedure approximately 3-4 times over a 90 second period. | Other | Manual therapy and vagus nerve stimulation group, Manual therapy group |
| Passive stretchingPassive stretches will be applied to each muscle 2 times for 30 seconds, they will be performed slowly at the rate of the patient's normal breathing and checking that no compensations appear. | Other | Manual therapy and vagus nerve stimulation group, Manual therapy group |
| Diaphragmatic breathing exerciceTo perform diaphragmatic breaths, there will first be an education on how to do them. The patient will lie supine, with the hips and knees semi-flexed. The therapist will ask you to place one hand on your chest and one on your abdomen. Successively, it will ask you to take a few deep breaths, inhaling through your nose for 2 seconds and exhaling through your mouth, with your lips pursed (almost closed) for 4 seconds, helping you to maintain the rhythm of your breath by counting out loud. The patient should note that during inspiration his hand on top of the chest does not rise (the chest remains still) and during expiration that his hand on top of the abdomen goes down (the abdomen sinks). | Other | Manual therapy and vagus nerve stimulation group |
Primary outcome
Change in Pain intensity
Time frame: Day 1 (before the intervention), Day 28 (after the last intervention), Day 56 (4 weeks after the last intervention).
The strength with which the participants subjectively feel their headache. It will be measured with the following degrees: mild, moderate or severe. The Headache Disability Inventory will be used to measure pain intensity.
4 secondary outcomes
Change in Headache frequency
Time frame: Day 1 (before the intervention), Day 28 (after the last intervention), Day 56 (4 weeks after the last intervention).
Change in Impact of pain
Time frame: Day 1 (before the intervention), Day 28 (after the last intervention), Day 56 (4 weeks after the last intervention).
Change in Pain threshold
Time frame: Day 1 (before the intervention), Day 28 (after the last intervention).
Change in Cervical Range of Motion
Time frame: Day 1 (before the intervention), Day 28 (after the last intervention).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2021.
- Individual participant dataSharing planned: No
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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.
ALEJANDRO FERRAGUT, DOCTOR principal investigator
Universidad Alcalá de Henares
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Suboccipital inhibition, Ischemic pressure and Passive stretching in people with Chronic Tension-Type Headache and Episodic Tension-Type Headache, run by Lucia Trullenque Espallargas at 2 sites 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 7 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: status not confirmed, as of the sponsor's last update on 28 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact LUCIA TRULLENQUE, STUDENT (649389616, fisioterapialuciatrullenque@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain intensity (time frame: Day 1 (before the intervention), Day 28 (after the last intervention), Day 56 (4 weeks after the last intervention).). 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 28 Oct 2021.