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

NCT05097300 | Unknown

• 1 other identifier: CEIM/2021/1/017
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 2

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.

Conditions

Chronic Tension-Type Headache; Episodic Tension-Type Headache

Keywords

Tension type headache; Manual therapy; Vagus nerve stimulation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in 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

  Day 1 (before the intervention), Day 28 (after the last intervention), Day 56 (4 weeks after the last intervention).

• Change in Pain threshold

  Day 1 (before the intervention), Day 28 (after the last intervention).

• Change in Cervical Range of Motion

  Day 1 (before the intervention), Day 28 (after the last intervention).

Study Arms (2)

Manual therapy and vagus nerve stimulation group

EXPERIMENTAL

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; Other: Ischemic pressure; Other: Passive stretching; Other: Diaphragmatic breathing exercice

Manual therapy group

ACTIVE COMPARATOR

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; Other: Ischemic pressure; Other: Passive stretching

Interventions

Suboccipital inhibition OTHER

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

Manual therapy and vagus nerve stimulation group; Manual therapy group

Ischemic pressure OTHER

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.

Manual therapy and vagus nerve stimulation group; Manual therapy group

Passive stretching OTHER

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.

Manual therapy and vagus nerve stimulation group; Manual therapy group

Diaphragmatic breathing exercice OTHER

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).

Manual therapy and vagus nerve stimulation group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with episodic or chronic tension type headache

You may not qualify if:

• 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

Sponsors & Collaborators

• Lucia Trullenque Espallargas: lead

Study Sites (2)

Fisioterapia FIMA clinic

Madrid, 28029, Spain

Location

Facultad de Enfermería y fisioterapia, Universidad Alcalá de Henares

Madrid, 28805, Spain

Location

MeSH Terms

Conditions

Tension-Type Headache

Interventions

Muscle Stretching Exercises

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• ALEJANDRO FERRAGUT, DOCTOR

  Universidad Alcalá de Henares

  PRINCIPAL INVESTIGATOR

Central Study Contacts

LUCIA TRULLENQUE, STUDENT

CONTACT

649389616; fisioterapialuciatrullenque@gmail.com

PAOLA FORTUNIO, STUDENT

CONTACT

609500069; fortunio.pala@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: STUDIENT

Study Record Dates

• First Submitted: September 14, 2021
• First Posted: October 28, 2021
• Study Start: November 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: October 28, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)