Treatment of Tension Headache Using Soft Tissue Techniques VS Vagus Stimulation Techniques.
NCT ID: NCT05097300
Last Updated: 2021-10-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
42 participants
INTERVENTIONAL
2021-11-01
2021-12-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* 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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Manual therapy and vagus nerve stimulation group
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.
Suboccipital inhibition
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 pressure
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 stretching
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 exercice
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).
Manual therapy group
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).
Suboccipital inhibition
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 pressure
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 stretching
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Suboccipital inhibition
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 pressure
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 stretching
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 exercice
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).
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Lucia Trullenque Espallargas
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Lucia Trullenque Espallargas
STUDIENT
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
ALEJANDRO FERRAGUT, DOCTOR
Role: PRINCIPAL_INVESTIGATOR
Universidad Alcalá de Henares
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Fisioterapia FIMA clinic
Madrid, , Spain
Facultad de Enfermería y fisioterapia, Universidad Alcalá de Henares
Madrid, , Spain
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CEIM/2021/1/017
Identifier Type: -
Identifier Source: org_study_id