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

Primary Purpose

Chronic Tension-Type Headache, Episodic Tension-Type Headache

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Suboccipital inhibition
Ischemic pressure
Passive stretching
Diaphragmatic breathing exercice
Sponsored by
Lucia Trullenque Espallargas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Tension-Type Headache focused on measuring Tension type headache, Manual therapy, Vagus nerve stimulation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fisioterapia FIMA clinic
  • Facultad de Enfermería y fisioterapia, Universidad Alcalá de Henares

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Manual therapy and vagus nerve stimulation group

Manual therapy group

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
September 14, 2021
Last Updated
October 15, 2021
Sponsor
Lucia Trullenque Espallargas
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1. Study Identification

Unique Protocol Identification Number
NCT05097300
Brief Title
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

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2021 (Anticipated)
Primary Completion Date
December 1, 2021 (Anticipated)
Study Completion Date
December 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Lucia Trullenque Espallargas

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Tension-Type Headache, Episodic Tension-Type Headache
Keywords
Tension type headache, Manual therapy, Vagus nerve stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Manual therapy and vagus nerve stimulation group
Arm Type
Experimental
Arm Description
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.
Arm Title
Manual therapy group
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Suboccipital inhibition
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Ischemic pressure
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Passive stretching
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Diaphragmatic breathing exercice
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change in Pain intensity
Description
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.
Time Frame
Day 1 (before the intervention), Day 28 (after the last intervention), Day 56 (4 weeks after the last intervention).
Secondary Outcome Measure Information:
Title
Change in Headache frequency
Description
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.
Time Frame
Day 1 (before the intervention), Day 28 (after the last intervention), Day 56 (4 weeks after the last intervention).
Title
Change in Impact of pain
Description
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.
Time Frame
Day 1 (before the intervention), Day 28 (after the last intervention), Day 56 (4 weeks after the last intervention).
Title
Change in Pain threshold
Description
Amount of pressure needed to change the patient's sensation from pressure to pain. It will be measured with an algometer, in Newton.
Time Frame
Day 1 (before the intervention), Day 28 (after the last intervention).
Title
Change in Cervical Range of Motion
Description
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.
Time Frame
Day 1 (before the intervention), Day 28 (after the last intervention).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
LUCIA TRULLENQUE, STUDENT
Phone
649389616
Email
fisioterapialuciatrullenque@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
PAOLA FORTUNIO, STUDENT
Phone
609500069
Email
fortunio.pala@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ALEJANDRO FERRAGUT, DOCTOR
Organizational Affiliation
Universidad Alcalá de Henares
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fisioterapia FIMA clinic
City
Madrid
ZIP/Postal Code
28029
Country
Spain
Facility Name
Facultad de Enfermería y fisioterapia, Universidad Alcalá de Henares
City
Madrid
ZIP/Postal Code
28805
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

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

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