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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05842642
Other study ID # Universidad de Alcalá
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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