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Treatment of Tension Headache Using Soft Tissue Techniques VS Vagus Stimulation Techniques.

Tratamiento de la Cefalea Tensional Mediante técnicas de Tejido Blando VS técnicas de estimulación Del Vago.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05097300
Enrollment
42
Registered
2021-10-28
Start date
2021-11-01
Completion date
2021-12-01
Last updated
2021-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Tension-Type Headache, Episodic Tension-Type Headache

Keywords

Tension type headache, Manual therapy, Vagus nerve stimulation

Brief 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.

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.

Interventions

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

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 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.

OTHERDiaphragmatic 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).

Sponsors

Lucia Trullenque Espallargas
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Patients diagnosed with episodic or chronic tension type headache

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Change in Pain intensityDay 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.

Secondary

MeasureTime frameDescription
Change in Headache frequencyDay 1 (before the intervention), Day 28 (after the last intervention), Day 56 (4 weeks after the last intervention).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.
Change in Impact of painDay 1 (before the intervention), Day 28 (after the last intervention), Day 56 (4 weeks after the last intervention).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.
Change in Pain thresholdDay 1 (before the intervention), Day 28 (after the last intervention).Amount of pressure needed to change the patient's sensation from pressure to pain. It will be measured with an algometer, in Newton.
Change in Cervical Range of MotionDay 1 (before the intervention), Day 28 (after the last intervention).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.

Countries

Spain

Contacts

Primary ContactLUCIA TRULLENQUE, STUDENT
fisioterapialuciatrullenque@gmail.com649389616
Backup ContactPAOLA FORTUNIO, STUDENT
fortunio.pala@gmail.com609500069

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026