Effects of Adding an Oculomotor Therapy Treatment in Patients With Migraine

Migraine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05842642
• Other study ID #: Universidad de Alcalá
• Status: Completed
• Phase: N/A
• Start date: April 3, 2023
• Est. completion date: September 15, 2023

Study information

• Verified date: September 2023
• Source: University of Jaén
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: September 15, 2023
• Est. primary completion date: May 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Other:
• Cervical
6 weeks of treatment
• Oculomotor
6 weeks of treatment

Locations

Country	Name	City	State
Spain	Physiotherapy clinic	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
University of Jaén

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in the impact	Using the Headache Impact Test (HIT-6) Questionnaire	Baseline, 6 weeks and 3 months after intervention
Secondary	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
Secondary	Changes in the disability	Using the Migraine Disability Assessment (MIDAS) Questionnaire	Baseline, 6 weeks and 3 months after intervention
Secondary	Changes in the depression	Using the Patient Health Questionnaire (PHQ-9) Questionnaire	Baseline, 6 weeks and 3 months after intervention
Secondary	Changes in the anxiety	Using the Generalized Anxiety Disorder (GAD-7) Questionnaire	Baseline, 6 weeks and 3 months after intervention
Secondary	Changes in the sleep quality	Using the Pittsburgh Sleep Quality Index (PSQI) Questionnaire	Baseline, 6 weeks and 3 months after intervention
Secondary	Changes in the kinesiophobia	Using the Tampa Scale of Kinesiophobia (TSK-11) Questionnaire	Baseline, 6 weeks and 3 months after intervention
Secondary	Changes in the catastrophizing	Using the Pain Catastrophizing Scale (PCS) Questionnaire	Baseline, 6 weeks and 3 months after intervention
Secondary	Changes in the central sensitization	Using the Central Sensitization Inventory (CSI) Questionnaire	Baseline, 6 weeks and 3 months after intervention
Secondary	Changes in the neck disability	Using the Neck Disability Index (NDI) Questionnaire	Baseline, 6 weeks and 3 months after intervention
Secondary	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
Secondary	Changes in the strength of the deep cervical flexors	Using the Grimmer Test	Baseline, 6 weeks and 3 months after intervention
Secondary	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
Secondary	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
Secondary	Changes in the range of movement	Using the Cervical Range of Motion Instrument	Baseline, 6 weeks and 3 months after intervention
Secondary	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