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Completed

NCT Number: NCT05842642

Effects of Adding an Oculomotor Therapy Treatment in Patients With Migraine

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).

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Physiotherapy clinic

Madrid, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

cervical

Other

6 weeks of treatment

Oculomotor

Other

6 weeks of treatment

Primary outcomes

  1. Changes in the impact

    Time frame: Baseline, 6 weeks and 3 months after intervention

    Using the Headache Impact Test (HIT-6) Questionnaire

Secondary outcomes

  1. Changes in the pain

    Time frame: 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.

  2. Changes in the disability

    Time frame: Baseline, 6 weeks and 3 months after intervention

    Using the Migraine Disability Assessment (MIDAS) Questionnaire

  3. Changes in the depression

    Time frame: Baseline, 6 weeks and 3 months after intervention

    Using the Patient Health Questionnaire (PHQ-9) Questionnaire

  4. Changes in the anxiety

    Time frame: Baseline, 6 weeks and 3 months after intervention

    Using the Generalized Anxiety Disorder (GAD-7) Questionnaire

  5. Changes in the sleep quality

    Time frame: Baseline, 6 weeks and 3 months after intervention

    Using the Pittsburgh Sleep Quality Index (PSQI) Questionnaire

  6. Changes in the kinesiophobia

    Time frame: Baseline, 6 weeks and 3 months after intervention

    Using the Tampa Scale of Kinesiophobia (TSK-11) Questionnaire

  7. Changes in the catastrophizing

    Time frame: Baseline, 6 weeks and 3 months after intervention

    Using the Pain Catastrophizing Scale (PCS) Questionnaire

  8. Changes in the central sensitization

    Time frame: Baseline, 6 weeks and 3 months after intervention

    Using the Central Sensitization Inventory (CSI) Questionnaire

  9. Changes in the neck disability

    Time frame: Baseline, 6 weeks and 3 months after intervention

    Using the Neck Disability Index (NDI) Questionnaire

  10. Changes in the head repositioning

    Time frame: 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 error

  11. Changes in the strength of the deep cervical flexors

    Time frame: Baseline, 6 weeks and 3 months after intervention

    Using the Grimmer Test

  12. Changes in the ocular movement

    Time frame: 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".

  13. Changes in the ocular movement with variation of the head

    Time frame: 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

  14. Changes in the range of movement

    Time frame: Baseline, 6 weeks and 3 months after intervention

    Using the Cervical Range of Motion Instrument

  15. Changes in the quality of life

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Jaén

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 6, 2023
Registry last updated
Sep 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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