Effects of Adding an Oculomotor Therapy Treatment in Patients With Migraine

NCT ID: NCT05842642

Last Updated: 2023-09-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-03
• Study Completion Date: 2023-09-15

Brief Summary

Headaches are the fourth cause/reason for disability in the world population. Of which, headache in general accounts for 47%, 38% are tension headaches, 10% migraines and 3% for chronic headache lasting more than 15 days a month.

Migraine is a neurological disease/disorder originating in the central nervous system with difficulty modulating responses to common sensory stimuli.

Different studies have linked possible oculomotor problems and headaches, being an important and complex relationship.

It is difficult to find a suitable and beneficial treatment for the treatment of migraine. It is hypothesized that adding a treatment of manual therapy and therapeutic exercise of the oculomotor system to an already established protocol of manual therapy and therapeutic exercise of the cervical region, has an additional benefit for patients with migraines (in relation to the quality of life, symptomatology and functionality).

Detailed Description

Migraine is a neurological disease/disorder originating in the central nervous system with difficulty modulating responses to common sensory stimuli. It is characterized by being unilateral, frontotemporal, pulsatile, of moderate or severe intensity, nausea and/or vomiting, sensitivity to movement, visual, auditory, and other afferent stimuli may appear. In addition, other symptoms such as fatigue, neck stiffness, decreased concentration, mood swings and yawning may appear, and the headache may be anticipated up to 48 hours.

It has been hypothesized that the possible relationship between the eyes and the pathophysiology of migraine is due to the trigeminal-cervical complex, since if there is an alteration it would be established by a nociceptive impulse that can trigger central sensitization in the trigeminal nuclei.

Today, the quintessential treatment is pharmacological where the excessive use of medications can trigger possible side effects such as depression, anxiety, weight gain, fatigue and drowsiness, among others, causing an alteration in the patient's quality of life more than of the migraine attack.

Several studies show that there are other non-pharmacological treatment options such as manual physiotherapy and therapeutic exercise for migraines, and that it is effective for reducing the intensity and frequency of attacks, the use of medication and improving the quality of life. Being preventive treatments in order to avoid the frequency and intensity of these attacks.

At present, the role of oculomotricity in headache, although it may be promising, has not been extensively studied. In the literature that the investigators have reviewed, the investigators have found very few studies that investigate manual therapy directly on the eyeball, despite the great relationship of the trigeminal-vascular nerve with migraines and how it influences the different variables.

The main objective of the present study is to investigate the impact and possible additional benefits of adding an oculomotor treatment to a manual therapy protocol of the cervical region in patients with migraine.

Conditions

Migraine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Cervical treatment

A treatment of the cervical region will be done for 6 weeks, once a week, and they will be taught exercises to do at home.

Group Type: PLACEBO_COMPARATOR

Cervical

Intervention Type: OTHER

6 weeks of treatment

Oculomotor treatment

An oculomotor treatment will be added to the treatment of the cervical group with specific exercises in the area. Once a week during 6 weeks

Group Type: EXPERIMENTAL

Cervical

Intervention Type: OTHER

6 weeks of treatment

Oculomotor

Intervention Type: OTHER

6 weeks of treatment

Interventions

Cervical

6 weeks of treatment

Intervention Type: OTHER

Oculomotor

6 weeks of treatment

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age between 18-65 years
• Suffer less than 15 days of headache per month,
• The pain must have these characteristics: unilateral, pulsating, of moderate to severe intensity, during the attack, nausea and/or vomiting, with the possible presence of an aura
• History of evolution of more than a year,
• Onset and aggravation in the afternoon and
• Relation to visual work
• Feeling of eye discomfort,
• Photophobia
• Neck pain after attack.

Exclusion Criteria

• Receiving some type of preventive physiotherapy treatment at the time of the intervention
• Subjects with preventive medication, pregnancy or lactation, with neurological, systemic or psychiatric disorders, suffering from bone degeneration
• Metabolic or musculoskeletal problems that could imply risk of the vertebral artery
• Dizziness
• Unbalanced tension
• Use of specific medication
• Lack of fluency in Spanish.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Jaén

OTHER

Sponsor Role: lead

Responsible Party

Alexander Achalandabaso

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alexander Achalandabaso, PhD

Role: STUDY_DIRECTOR

University of Jaen

Locations

Physiotherapy clinic

Madrid, , Spain

Countries

Spain

Other Identifiers

Universidad de Alcalá

Identifier Type: -

Identifier Source: org_study_id