An interventional study of Cervical and Oculomotor in Migraine, sponsored by University of Jaén. Completed at 1 site in Spain. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-09-18.
Sponsored by University of Jaén · Not applicable, Interventional, and Treatment
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).
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.
1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.
This study's enrollment of 32 is below the median of 80 across 1,175 interventional studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →University of Jaén is the lead sponsor of 79 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
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
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 · Other: Oculomotor
6 weeks of treatment
6 weeks of treatment
Changes in the impact
Using the Headache Impact Test (HIT-6) Questionnaire
Time frame: Baseline, 6 weeks and 3 months after intervention
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.
Time frame: Baseline, 6 weeks and 3 months after intervention
Changes in the disability
Using the Migraine Disability Assessment (MIDAS) Questionnaire
Time frame: Baseline, 6 weeks and 3 months after intervention
Changes in the depression
Using the Patient Health Questionnaire (PHQ-9) Questionnaire
Time frame: Baseline, 6 weeks and 3 months after intervention
Changes in the anxiety
Using the Generalized Anxiety Disorder (GAD-7) Questionnaire
Time frame: Baseline, 6 weeks and 3 months after intervention
Changes in the sleep quality
Using the Pittsburgh Sleep Quality Index (PSQI) Questionnaire
Time frame: Baseline, 6 weeks and 3 months after intervention
Changes in the kinesiophobia
Using the Tampa Scale of Kinesiophobia (TSK-11) Questionnaire
Time frame: Baseline, 6 weeks and 3 months after intervention
Changes in the catastrophizing
Using the Pain Catastrophizing Scale (PCS) Questionnaire
Time frame: Baseline, 6 weeks and 3 months after intervention
Changes in the central sensitization
Using the Central Sensitization Inventory (CSI) Questionnaire
Time frame: Baseline, 6 weeks and 3 months after intervention
Changes in the neck disability
Using the Neck Disability Index (NDI) Questionnaire
Time frame: 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
Time frame: Baseline, 6 weeks and 3 months after intervention
Changes in the strength of the deep cervical flexors
Using the Grimmer Test
Time frame: 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".
Time frame: 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
Time frame: Baseline, 6 weeks and 3 months after intervention
Changes in the range of movement
Using the Cervical Range of Motion Instrument
Time frame: 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.
Time frame: Baseline, 6 weeks and 3 months after intervention
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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University of Jaén