Clinical trial NCT05097300: Treatment of Tension Headache Using Soft Tissue Techniques VS Vagus Stimulation Techniques.
Official title: Tratamiento de la Cefalea Tensional Mediante técnicas de Tejido Blando VS técnicas de estimulación Del Vago.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Tension-Type Headache
Episodic Tension-Type Headache
Keywords: Tension type headache
Manual therapy
Vagus nerve stimulation
Lead sponsor: University of Alcala
Sponsor class: OTHER
First posted: 2021-10-28
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Pain intensity
timeFrame: Day 1 (before the intervention), Day 28 (after the last intervention), Day 56 (4 weeks after the last intervention).
Secondary outcomes:
measure: Change in Headache frequency
timeFrame: Day 1 (before the intervention), Day 28 (after the last intervention), Day 56 (4 weeks after the last intervention).
measure: Change in Impact of pain
timeFrame: Day 1 (before the intervention), Day 28 (after the last intervention), Day 56 (4 weeks after the last intervention).
measure: Change in Pain threshold
timeFrame: Day 1 (before the intervention), Day 28 (after the last intervention).
measure: Change in Cervical Range of Motion
timeFrame: Day 1 (before the intervention), Day 28 (after the last intervention).
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Fisioterapia FIMA clinic
city: Madrid
country: Spain
facility: Facultad de Enfermería y fisioterapia, Universidad Alcalá de Henares
Study officials:
affiliation: Universidad Alcalá de Henares
name: ALEJANDRO FERRAGUT, DOCTOR
role: PRINCIPAL_INVESTIGATOR
References: