AzTrials
AzTrials

MigraineNCT05842642

Effects of Adding an Oculomotor Therapy Treatment in Patients With Migraine

A study testing Cervical and Oculomotor in people with Migraine, run by University of Jaén at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Migraine
What is being tested?
Cervical and Oculomotor
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
32 participants
Where
1 siteSpain
Study dates
3 Apr 2023to 15 Sep 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • Feeling of eye discomfort,
  • Photophobia
  • Neck pain after attack.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Physiotherapy clinic

    Madrid

Other trials in Spain

About this study

Official title: Effects of Adding an Oculomotor Therapy Treatment to a Cervical Protocol 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.

Read more

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).

Read the 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.

Conditions
Migraine
Being tested
Cervical, Oculomotor
Keywords
migraine, oculomotor, manual therapy, cervical
Medical subject headings
Migraine Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CervicalOther

    6 weeks of treatment

  • OculomotorOther

    6 weeks of treatment

Study groups in NCT05842642
Study groupRoleWhat they receive
Cervical treatmentPlacebo comparatorA treatment of the cervical region will be done for 6 weeks, once a week, and they will be taught exercises to do at home.
Receives: Other: Cervical
Oculomotor treatmentExperimentalAn oculomotor treatment will be added to the treatment of the cervical group with specific exercises in the area. Once a week during 6 weeks
Receives: Other: Cervical; Other: Oculomotor

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in the impact

    Using the Headache Impact Test (HIT-6) Questionnaire

    Measured: Baseline, 6 weeks and 3 months after intervention

Secondary outcomes (15)

  1. 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.

    Measured: Baseline, 6 weeks and 3 months after intervention

  2. Changes in the disability

    Using the Migraine Disability Assessment (MIDAS) Questionnaire

    Measured: Baseline, 6 weeks and 3 months after intervention

  3. Changes in the depression

    Using the Patient Health Questionnaire (PHQ-9) Questionnaire

    Measured: Baseline, 6 weeks and 3 months after intervention

  4. Changes in the anxiety

    Using the Generalized Anxiety Disorder (GAD-7) Questionnaire

    Measured: Baseline, 6 weeks and 3 months after intervention

  5. Changes in the sleep quality

    Using the Pittsburgh Sleep Quality Index (PSQI) Questionnaire

    Measured: Baseline, 6 weeks and 3 months after intervention

  6. Changes in the kinesiophobia

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

    Measured: Baseline, 6 weeks and 3 months after intervention

  7. Changes in the catastrophizing

    Using the Pain Catastrophizing Scale (PCS) Questionnaire

    Measured: Baseline, 6 weeks and 3 months after intervention

  8. Changes in the central sensitization

    Using the Central Sensitization Inventory (CSI) Questionnaire

    Measured: Baseline, 6 weeks and 3 months after intervention

  9. Changes in the neck disability

    Using the Neck Disability Index (NDI) Questionnaire

    Measured: Baseline, 6 weeks and 3 months after intervention

  10. 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

    Measured: Baseline, 6 weeks and 3 months after intervention

  11. Changes in the strength of the deep cervical flexors

    Using the Grimmer Test

    Measured: Baseline, 6 weeks and 3 months after intervention

  12. 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".

    Measured: Baseline, 6 weeks and 3 months after intervention

  13. 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

    Measured: Baseline, 6 weeks and 3 months after intervention

  14. Changes in the range of movement

    Using the Cervical Range of Motion Instrument

    Measured: Baseline, 6 weeks and 3 months after intervention

  15. 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.

    Measured: Baseline, 6 weeks and 3 months after intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2023
  2. Study start3 Apr 2023
  3. Primary completion30 May 2023
  4. Study completion15 Sep 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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 blind
Who is masked
Participant
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05842642
Sponsor's protocol ID
Universidad de Alcalá
Status last verified
Sep 2023
First submitted
7 Feb 2023
Last updated
18 Sep 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Cervical and Oculomotor in people with Migraine, run by University of Jaén at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in the impact (time frame: Baseline, 6 weeks and 3 months after intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05842642.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in