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

Chronic Tension-Type Headache Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05097300
• Other study ID #: CEIM/2021/1/017
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: December 1, 2021

Study information

• Verified date: October 2021
• Source: University of Alcala
• Contact: LUCIA TRULLENQUE, STUDENT
• Phone: 649389616
• Email: fisioterapialuciatrullenque[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 42
• Est. completion date: December 1, 2021
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Tension-Type Headache
• Episodic Tension-Type Headache
• Headache
• Tension-Type Headache

Intervention

Other:
• 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).

Locations

Country	Name	City	State
Spain	Facultad de Enfermería y fisioterapia, Universidad Alcalá de Henares	Madrid
Spain	Fisioterapia FIMA clinic	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Lucia Trullenque Espallargas

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 1 (before the intervention), Day 28 (after the last intervention), Day 56 (4 weeks after the last intervention).
Secondary	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.	Day 1 (before the intervention), Day 28 (after the last intervention), Day 56 (4 weeks after the last intervention).
Secondary	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.	Day 1 (before the intervention), Day 28 (after the last intervention), Day 56 (4 weeks after the last intervention).
Secondary	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.	Day 1 (before the intervention), Day 28 (after the last intervention).
Secondary	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.	Day 1 (before the intervention), Day 28 (after the last intervention).