Clinical trial NCT05842642: Effects of Adding an Oculomotor Therapy Treatment in Patients With Migraine
Official title: Effects of Adding an Oculomotor Therapy Treatment to a Cervical Protocol in Patients With Migraine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine
Keywords: migraine
oculomotor
manual therapy
cervical
Lead sponsor: University of Jaén
Sponsor class: OTHER
First posted: 2023-05-06
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups, a control group and an experimental group. In the control group, a treatment of the cervical region will be done for 6 weeks, once a week, and they will be taught some exercises to do at home. And in the experimental group, the treatment of the control group will be done plus an additional intervention in the oculomotor region together with some specific exercises.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Changes in the impact
timeFrame: Baseline, 6 weeks and 3 months after intervention
Secondary outcomes:
measure: Changes in the pain
timeFrame: Baseline, 6 weeks and 3 months after intervention
measure: Changes in the disability
timeFrame: Baseline, 6 weeks and 3 months after intervention
measure: Changes in the depression
timeFrame: Baseline, 6 weeks and 3 months after intervention
measure: Changes in the anxiety
timeFrame: Baseline, 6 weeks and 3 months after intervention
measure: Changes in the sleep quality
timeFrame: Baseline, 6 weeks and 3 months after intervention
measure: Changes in the kinesiophobia
timeFrame: Baseline, 6 weeks and 3 months after intervention
measure: Changes in the catastrophizing
timeFrame: Baseline, 6 weeks and 3 months after intervention
measure: Changes in the central sensitization
timeFrame: Baseline, 6 weeks and 3 months after intervention
measure: Changes in the neck disability
timeFrame: Baseline, 6 weeks and 3 months after intervention
measure: Changes in the head repositioning
timeFrame: Baseline, 6 weeks and 3 months after intervention
measure: Changes in the strength of the deep cervical flexors
timeFrame: Baseline, 6 weeks and 3 months after intervention
measure: Changes in the ocular movement
timeFrame: Baseline, 6 weeks and 3 months after intervention
measure: Changes in the ocular movement with variation of the head
timeFrame: Baseline, 6 weeks and 3 months after intervention
measure: Changes in the range of movement
timeFrame: Baseline, 6 weeks and 3 months after intervention
measure: Changes in the quality of life
timeFrame: Baseline, 6 weeks and 3 months after intervention
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Physiotherapy clinic
Study officials:
affiliation: University of Jaen
name: Alexander Achalandabaso, PhD
role: STUDY_DIRECTOR
References: