Effects of Adding an Oculomotor Therapy Treatment in Patients With Migraine
- Conditions
- Migraine
- Interventions
- Other: CervicalOther: Oculomotor
- Registration Number
- NCT05842642
- Lead Sponsor
- University of Jaén
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cervical treatment Cervical 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. Oculomotor treatment 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 Oculomotor treatment Oculomotor 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
- Primary Outcome Measures
Name Time Method Changes in the impact Baseline, 6 weeks and 3 months after intervention Using the Headache Impact Test (HIT-6) Questionnaire
- Secondary Outcome Measures
Name Time Method Changes in the disability Baseline, 6 weeks and 3 months after intervention Using the Migraine Disability Assessment (MIDAS) Questionnaire
Changes in the depression Baseline, 6 weeks and 3 months after intervention Using the Patient Health Questionnaire (PHQ-9) Questionnaire
Changes in the kinesiophobia Baseline, 6 weeks and 3 months after intervention Using the Tampa Scale of Kinesiophobia (TSK-11) Questionnaire
Changes in the head repositioning Baseline, 6 weeks and 3 months after intervention 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 errorChanges in the ocular movement with variation of the head Baseline, 6 weeks and 3 months after intervention 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
Changes in the range of movement Baseline, 6 weeks and 3 months after intervention Using the Cervical Range of Motion Instrument
Changes in the pain Baseline, 6 weeks and 3 months after intervention 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.
Changes in the anxiety Baseline, 6 weeks and 3 months after intervention Using the Generalized Anxiety Disorder (GAD-7) Questionnaire
Changes in the sleep quality Baseline, 6 weeks and 3 months after intervention Using the Pittsburgh Sleep Quality Index (PSQI) Questionnaire
Changes in the catastrophizing Baseline, 6 weeks and 3 months after intervention Using the Pain Catastrophizing Scale (PCS) Questionnaire
Changes in the central sensitization Baseline, 6 weeks and 3 months after intervention Using the Central Sensitization Inventory (CSI) Questionnaire
Changes in the neck disability Baseline, 6 weeks and 3 months after intervention Using the Neck Disability Index (NDI) Questionnaire
Changes in the strength of the deep cervical flexors Baseline, 6 weeks and 3 months after intervention Using the Grimmer Test
Changes in the quality of life Baseline, 6 weeks and 3 months after intervention 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.
Changes in the ocular movement Baseline, 6 weeks and 3 months after intervention 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".
Trial Locations
- Locations (1)
Physiotherapy clinic
🇪🇸Madrid, Spain