Effects of Adding an Oculomotor Therapy Treatment in Patients With Migraine

NCT05842642 | Completed

• 1 other identifier: Universidad de Alcalá
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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).

Conditions

Migraine

Keywords

migraine; oculomotor; manual therapy; cervical

Outcome Measures

Primary Outcomes (1)

• Changes in the impact

  Using the Headache Impact Test (HIT-6) Questionnaire

  Baseline, 6 weeks and 3 months after intervention

Secondary Outcomes (15)

• Changes in the pain

  Baseline, 6 weeks and 3 months after intervention

• Changes in the disability

  Baseline, 6 weeks and 3 months after intervention

• Changes in the depression

  Baseline, 6 weeks and 3 months after intervention

• Changes in the anxiety

  Baseline, 6 weeks and 3 months after intervention

• Changes in the sleep quality

  Baseline, 6 weeks and 3 months after intervention

Study Arms (2)

Cervical treatment

PLACEBO COMPARATOR

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

Oculomotor treatment

EXPERIMENTAL

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

Interventions

Cervical OTHER

6 weeks of treatment

Cervical treatment; Oculomotor treatment

Oculomotor OTHER

6 weeks of treatment

Oculomotor treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Jaén: lead

Study Sites (1)

Physiotherapy clinic

Madrid, Spain

Location

MeSH Terms

Conditions

Migraine Disorders

Interventions

SETX protein, human

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Alexander Achalandabaso, PhD

  University of Jaen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Upon acceptance, each participant will be assigned a treatment group. Before starting the intervention, all the subjects will go to the UAH physiotherapy center for a first visit with the first examiner where personal data will be collected and sociodemographic, psychometric and functional variables will be assessed. At the end of said evaluation, a second examiner gave them the steps to follow to carry out the study. In addition, you will be given a document with a table that will be your migraine diary that you must fill in every day from the start of treatment until the day of the last assessment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: 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.

Study Record Dates

• First Submitted: February 7, 2023
• First Posted: May 6, 2023
• Study Start: April 3, 2023
• Primary Completion: May 30, 2023
• Study Completion: September 15, 2023
• Last Updated: September 18, 2023

Record last verified: 2023-09

Locations

ES (1)