Effects of Adding an Oculomotor Therapy Treatment in Patients With Migraine

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of Adding an Oculomotor Therapy Treatment to a Cervical Protocol in Patients With Migraine

Conditions
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Migraine

Intervention / Treatment
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* Other: Cervical
* Other: Oculomotor


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Cervical treatment<br>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. | Other: Cervical<br>* 6 weeks of treatment<br>|
| Experimental: Oculomotor treatment<br>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 | Other: Cervical<br>* 6 weeks of treatment<br>Other: Oculomotor<br>* 6 weeks of treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the impact | Using the Headache Impact Test (HIT-6) Questionnaire | Baseline, 6 weeks and 3 months after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the pain | Using the Visual Analog Scale (VAS). Each item is scored 0-10 (0= no pain; 10= the major pain that the patient can imagine) yielding a total between 0 and 10. | Baseline, 6 weeks and 3 months after intervention | 
| Changes in the disability | Using the Migraine Disability Assessment (MIDAS) Questionnaire | Baseline, 6 weeks and 3 months after intervention | 
| Changes in the depression | Using the Patient Health Questionnaire (PHQ-9) Questionnaire | Baseline, 6 weeks and 3 months after intervention | 
| Changes in the anxiety | Using the Generalized Anxiety Disorder (GAD-7) Questionnaire | Baseline, 6 weeks and 3 months after intervention | 
| Changes in the sleep quality | Using the Pittsburgh Sleep Quality Index (PSQI) Questionnaire | Baseline, 6 weeks and 3 months after intervention | 
| Changes in the kinesiophobia | Using the Tampa Scale of Kinesiophobia (TSK-11) Questionnaire | Baseline, 6 weeks and 3 months after intervention | 
| Changes in the catastrophizing | Using the Pain Catastrophizing Scale (PCS) Questionnaire | Baseline, 6 weeks and 3 months after intervention | 
| Changes in the central sensitization | Using the Central Sensitization Inventory (CSI) Questionnaire | Baseline, 6 weeks and 3 months after intervention | 
| Changes in the neck disability | Using the Neck Disability Index (NDI) Questionnaire | Baseline, 6 weeks and 3 months after intervention | 
| Changes in the head repositioning | Using the Head Repositioning. This test will be used to assess the subject's proprioceptive ability to reposition the head on the trunk in the horizontal and sagittal planes and to measure the impact of treatment techniques. The distance between the center of the objective (target) and the laser point is measured, representing the cervico-cephalic positioning error | Baseline, 6 weeks and 3 months after intervention | 
| Changes in the strength of the deep cervical flexors | Using the Grimmer Test | Baseline, 6 weeks and 3 months after intervention | 
| Changes in the ocular movement | Using Smooth tracking test. It consists of following with the eyes an object (stick with a painted dot) that moves in the shape of an H. | Baseline, 6 weeks and 3 months after intervention | 
| Changes in the ocular movement with variation of the head | Using the Smooth Pursuit Neck Torsion. It consists of following with the eyes an object (stick with a painted dot) that moves in the shape of an H with variant head position | Baseline, 6 weeks and 3 months after intervention | 
| Changes in the range of movement | Using the Cervical Range of Motion Instrument | Baseline, 6 weeks and 3 months after intervention | 
| Changes in the quality of life | Using the Short-Form 12 Health Survey (SF-12). Composed of twelve items, eight dimensions (physical function, physical role, bodily pain, mental health, general health, vitality, social function, and emotional role). The score ranges from 0 to 100, where the higher score implies a better health-related quality of life. | Baseline, 6 weeks and 3 months after intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cervical, migraine, oculomotor, manual therapy