NCT05097300

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 14, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 28, 2021

Completed
4 days until next milestone

Study Start

First participant enrolled

November 1, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

October 28, 2021

Status Verified

October 1, 2021

Enrollment Period

1 month

First QC Date

September 14, 2021

Last Update Submit

October 15, 2021

Conditions

Chronic Tension-Type HeadacheEpisodic Tension-Type Headache

Keywords

Tension type headacheManual therapyVagus 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 inhibitionOther: Ischemic pressureOther: Passive stretchingOther: 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 inhibitionOther: Ischemic pressureOther: Passive stretching

Interventions

Suboccipital inhibitionOTHER

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 groupManual therapy group
Ischemic pressureOTHER

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 groupManual therapy group
Passive stretchingOTHER

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 groupManual therapy group
Diaphragmatic breathing exerciceOTHER

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

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • ALEJANDRO FERRAGUT, DOCTOR

    Universidad Alcalá de Henares

    PRINCIPAL INVESTIGATOR

Central Study Contacts

LUCIA TRULLENQUE, STUDENT

CONTACT

649389616fisioterapialuciatrullenque@gmail.com

PAOLA FORTUNIO, STUDENT

CONTACT

609500069fortunio.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)