Treatment of Tension Headache Using Soft Tissue Techniques VS Vagus Stimulation Techniques.
- Conditions
- Episodic Tension-Type HeadacheChronic Tension-Type Headache
- Registration Number
- NCT05097300
- Lead Sponsor
- Lucia Trullenque Espallargas
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 42
- Patients diagnosed with episodic or chronic tension type headache
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change in Pain intensity 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.
- Secondary Outcome Measures
Name Time Method Change in Impact of pain Day 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 Headache frequency Day 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 Pain threshold Day 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 Motion Day 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.
Trial Locations
- Locations (2)
Fisioterapia FIMA clinic
🇪🇸Madrid, Spain
Facultad de Enfermería y fisioterapia, Universidad Alcalá de Henares
🇪🇸Madrid, Spain
Fisioterapia FIMA clinic🇪🇸Madrid, Spain