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Effects of Adding an Oculomotor Therapy Treatment in Patients With Migraine

Primary Purpose

Migraine

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Cervical
Oculomotor
Sponsored by
University of Jaén
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine focused on measuring migraine, oculomotor, manual therapy, cervical

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Physiotherapy clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Cervical treatment

Oculomotor treatment

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Changes in the impact
Using the Headache Impact Test (HIT-6) Questionnaire

Secondary Outcome Measures

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.
Changes in the disability
Using the Migraine Disability Assessment (MIDAS) Questionnaire
Changes in the depression
Using the Patient Health Questionnaire (PHQ-9) Questionnaire
Changes in the anxiety
Using the Generalized Anxiety Disorder (GAD-7) Questionnaire
Changes in the sleep quality
Using the Pittsburgh Sleep Quality Index (PSQI) Questionnaire
Changes in the kinesiophobia
Using the Tampa Scale of Kinesiophobia (TSK-11) Questionnaire
Changes in the catastrophizing
Using the Pain Catastrophizing Scale (PCS) Questionnaire
Changes in the central sensitization
Using the Central Sensitization Inventory (CSI) Questionnaire
Changes in the neck disability
Using the Neck Disability Index (NDI) Questionnaire
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
Changes in the strength of the deep cervical flexors
Using the Grimmer Test
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".
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
Changes in the range of movement
Using the Cervical Range of Motion Instrument
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.

Full Information

First Posted
February 7, 2023
Last Updated
September 15, 2023
Sponsor
University of Jaén
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1. Study Identification

Unique Protocol Identification Number
NCT05842642
Brief Title
Effects of Adding an Oculomotor Therapy Treatment in Patients With Migraine
Official Title
Effects of Adding an Oculomotor Therapy Treatment to a Cervical Protocol in Patients With Migraine
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
April 3, 2023 (Actual)
Primary Completion Date
May 30, 2023 (Actual)
Study Completion Date
September 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Jaén

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
Keywords
migraine, oculomotor, manual therapy, cervical

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Participant
Masking Description
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.
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cervical treatment
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Oculomotor treatment
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Cervical
Intervention Description
6 weeks of treatment
Intervention Type
Other
Intervention Name(s)
Oculomotor
Intervention Description
6 weeks of treatment
Primary Outcome Measure Information:
Title
Changes in the impact
Description
Using the Headache Impact Test (HIT-6) Questionnaire
Time Frame
Baseline, 6 weeks and 3 months after intervention
Secondary Outcome Measure Information:
Title
Changes in the pain
Description
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.
Time Frame
Baseline, 6 weeks and 3 months after intervention
Title
Changes in the disability
Description
Using the Migraine Disability Assessment (MIDAS) Questionnaire
Time Frame
Baseline, 6 weeks and 3 months after intervention
Title
Changes in the depression
Description
Using the Patient Health Questionnaire (PHQ-9) Questionnaire
Time Frame
Baseline, 6 weeks and 3 months after intervention
Title
Changes in the anxiety
Description
Using the Generalized Anxiety Disorder (GAD-7) Questionnaire
Time Frame
Baseline, 6 weeks and 3 months after intervention
Title
Changes in the sleep quality
Description
Using the Pittsburgh Sleep Quality Index (PSQI) Questionnaire
Time Frame
Baseline, 6 weeks and 3 months after intervention
Title
Changes in the kinesiophobia
Description
Using the Tampa Scale of Kinesiophobia (TSK-11) Questionnaire
Time Frame
Baseline, 6 weeks and 3 months after intervention
Title
Changes in the catastrophizing
Description
Using the Pain Catastrophizing Scale (PCS) Questionnaire
Time Frame
Baseline, 6 weeks and 3 months after intervention
Title
Changes in the central sensitization
Description
Using the Central Sensitization Inventory (CSI) Questionnaire
Time Frame
Baseline, 6 weeks and 3 months after intervention
Title
Changes in the neck disability
Description
Using the Neck Disability Index (NDI) Questionnaire
Time Frame
Baseline, 6 weeks and 3 months after intervention
Title
Changes in the head repositioning
Description
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
Time Frame
Baseline, 6 weeks and 3 months after intervention
Title
Changes in the strength of the deep cervical flexors
Description
Using the Grimmer Test
Time Frame
Baseline, 6 weeks and 3 months after intervention
Title
Changes in the ocular movement
Description
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".
Time Frame
Baseline, 6 weeks and 3 months after intervention
Title
Changes in the ocular movement with variation of the head
Description
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
Time Frame
Baseline, 6 weeks and 3 months after intervention
Title
Changes in the range of movement
Description
Using the Cervical Range of Motion Instrument
Time Frame
Baseline, 6 weeks and 3 months after intervention
Title
Changes in the quality of life
Description
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.
Time Frame
Baseline, 6 weeks and 3 months after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander Achalandabaso, PhD
Organizational Affiliation
University of Jaen
Official's Role
Study Director
Facility Information:
Facility Name
Physiotherapy clinic
City
Madrid
Country
Spain

12. IPD Sharing Statement

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Effects of Adding an Oculomotor Therapy Treatment in Patients With Migraine

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