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.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Tension-Type Headache; Episodic Tension-Type Headache
• Intervention / Treatment: Other: Suboccipital inhibition; Other: Ischemic pressure; Other: Passive stretching; Other: Diaphragmatic breathing exercice

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.

• Study Type: Interventional
• Enrollment (Anticipated): 42
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: LUCIA TRULLENQUE, STUDENT; Phone Number: 649389616; Email: fisioterapialuciatrullenque@gmail.com
• Study Contact Backup: Name: PAOLA FORTUNIO, STUDENT; Phone Number: 609500069; Email: fortunio.pala@gmail.com

Study Locations

• Spain
  • Madrid, Spain, 28029
    • Fisioterapia FIMA clinic
  • Madrid, Spain, 28805
    • Facultad de Enfermería y fisioterapia, Universidad Alcalá de Henares

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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; Other: 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.; Other: 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.; Other: 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).
Active Comparator: 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).	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; Other: 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.; Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).
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).
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).
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).

Collaborators and Investigators

• Sponsor: Lucia Trullenque Espallargas
• Investigators: Principal Investigator: ALEJANDRO FERRAGUT, DOCTOR, Universidad Alcala de Henares

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2021
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: September 14, 2021
• First Submitted That Met QC Criteria: October 15, 2021
• First Posted (Actual): October 28, 2021

Study Record Updates

• Last Update Posted (Actual): October 28, 2021
• Last Update Submitted That Met QC Criteria: October 15, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Vagus nerve stimulation; Manual therapy; Tension type headache
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders, Primary; Headache Disorders; Headache; Tension-Type Headache
• Other Study ID Numbers: CEIM/2021/1/017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No