Myotensive Extraocular Muscle Techniques Added to Manual Therapy for Migraine Without Aura
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In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Myotensive Extraocular Muscle Techniques + Manual Therapy, Standard Manual Therapy.
- Who it may be relevant to
- Registry conditions: Migraine Without Aura. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy of Myotensive Techniques Applied to the Extraocular Muscles as an Adjunct to Manual Therapy in the Treatment of Migraine Without Aura
Overview
Migraine without aura is a highly prevalent and disabling primary headache that significantly affects quality of life. Many patients experience insufficient symptom control with pharmacological treatments or develop adverse effects, which has increased interest in safe, non-invasive therapeutic alternatives. Physiotherapy, and particularly manual therapy, has shown potential benefits in reducing pain and improving function in headache disorders. This randomized clinical trial will evaluate the effectiveness of adding specific myotensive techniques directed at the extraocular muscles to a craniocervical manual therapy program in adults with migraine without aura. The hypothesis is that targeting the oculomotor system may influence pain modulation and improve symptoms related to visual, cervical, and sensorimotor interactions. Ninety participants aged 18 to 65 years with a medical diagnosis of migraine without aura according to the International Classification of Headache Disorders, Third Edition (ICHD-III), will be randomly assigned to an experimental group or a control group. Both groups will receive six physiotherapy sessions over approximately eight weeks. The experimental group will receive manual therapy on the craniocervical region and temporomandibular joint (TMJ) combined with myotensive techniques for the extraocular muscles, while the control group will receive only the standard manual therapy protocol. Evaluations will be conducted at baseline and post-intervention using validated instruments such as the Migraine Disability Assessment (MIDAS), Craniofacial Pain and Disability Inventory (CF-PDI), Migraine-Specific Quality of Life Questionnaire (MSQ), and Visual Analogue Scale (VAS) for pain. Cervical mobility and oculomotor function will also be assessed through standardized clinical tests. All procedures will be carried out at the Faculty of Nursing, Physiotherapy and Podiatry of the University of Seville. Data will be collected and managed in digital format in compliance with the General Data Protection Regulation (GDPR) and Spanish data protection law. Study results are expected to clarify the role of the oculomotor system in migraine without aura and to determine whether incorporating extraocular myotensive techniques enhances the effects of manual therapy within a comprehensive physiotherapeutic approach.
Detailed description
Migraine without aura is a complex neurological condition involving interactions between sensory, musculoskeletal, and central regulatory systems. Its recurrent pain episodes, associated symptoms, and functional impact make it a major cause of disability. Despite therapeutic advances, a substantial proportion of patients continue to experience insufficient symptom control or intolerance to medication, reinforcing the need for complementary, non-pharmacological treatment strategies. Physiotherapy, and specifically manual therapy, has gained increased relevance due to its safety, individualized application, and potential influence on neuromuscular and sensorimotor mechanisms involved in migraine.
Alterations in the craniocervical region, including muscular hypertonicity, reduced mobility, and altered proprioception, are frequently observed in patients with migraine. These factors may contribute to pain modulation and central sensitization. Within this context, the oculomotor system has emerged as an area of interest due to its strong anatomical and functional connections with the upper cervical spine, brainstem integration centers, and vestibular and proprioceptive pathways. Extraocular muscles provide continuous proprioceptive input essential for coordinating gaze and head orientation. Dysfunction in this system may affect sensory integration, postural control, and cervico-ocular interactions, potentially contributing to increased sensory load and symptom exacerbation.
Myotensive techniques applied to the extraocular muscles aim to regulate muscle tone, optimize ocular motility, and influence afferent sensory input to central integration centers. When combined with manual therapy directed at the craniocervical region and temporomandibular joint (TMJ), these techniques may contribute to improving neuromuscular coordination and reducing migraine-related symptoms. This trial seeks to evaluate the clinical effects of incorporating extraocular myotensive techniques into a structured manual therapy program in patients with migraine without aura.
The study is a randomized, controlled, parallel-group clinical trial designed to compare two physiotherapy interventions. Ninety participants aged 18 to 65 years with a medical diagnosis of migraine without aura according to the International Classification of Headache Disorders, Third Edition (ICHD-III), will be randomly assigned through a computer-generated sequence to an experimental group or a control group. An independent researcher will manage allocation concealment using opaque, sealed envelopes. Evaluators will be blinded to group assignment, and data analysis will be conducted under blinded conditions.
Both groups will receive six physiotherapy sessions over approximately eight weeks. The experimental group will receive combined craniocervical manual therapy and specific myotensive techniques applied to the extraocular muscles. The control group will receive the same craniocervical manual therapy program without oculomotor techniques. All interventions will be administered by physiotherapists trained in manual therapy. Oculomotor assessments will be supervised by professionals with expertise in optometry.
Outcome measures will be assessed at baseline and post-intervention. Pain and disability will be evaluated through validated instruments, including the Visual Analogue Scale (VAS), Migraine Disability Assessment (MIDAS), Craniofacial Pain and Disability Inventory (CF-PDI), and the Migraine-Specific Quality of Life Questionnaire (MSQ). Cervical range of motion will be assessed using a gravity goniometer. Neuromuscular function of the deep cervical flexors will be evaluated through the Cranio-Cervical Flexion Test (CCFT) using pressure biofeedback in millimeters of mercury (mmHg), generating the Activation Score (AS) and Performance Index (PI). Oculomotor evaluation will include assessment of ocular motility, gaze-related pain perception, and functional changes in different gaze directions. Postural alignment of the head will be measured using goniometric procedures in a relaxed standing position. Heterophoria will be quantified using the Von Graefe test, expressed in prism diopters (Δ), with results categorized into esophoria (base-out, BO) or exophoria (base-in, BI) as applicable.
All study procedures will take place at the Faculty of Nursing, Physiotherapy and Podiatry of the University of Seville. Data collection will be performed exclusively through secure digital platforms, ensuring compliance with the General Data Protection Regulation (GDPR) and relevant Spanish legislation on personal data protection. The intervention is non-pharmacological and low-risk, and all participants will provide written informed consent prior to enrollment.
The purpose of this clinical trial is to determine whether incorporating specific techniques directed at the extraocular muscles enhances the effects of manual therapy in patients with migraine without aura. By examining changes in pain intensity, migraine frequency, disability, quality of life, cervical function, and oculomotor performance, this study aims to contribute new evidence to physiotherapy-based approaches and expand the range of safe and effective therapeutic options for individuals living with migraine.
Interventions
- Other Myotensive Extraocular Muscle Techniques + Manual Therapy
This intervention consists of six 55-minute sessions over eight weeks. It combines standard cranio-cervical manual therapy techniques-such as suboccipital inhibition, cervical traction, vertebral segmental mobilization, and temporomandibular joint decompression-with specific myotensive techniques applied to the extraocular muscles. The oculomotor component is performed in a supine position, using gentle isometric and eccentric tension-release maneuvers targeted to the most restricted eye movemen - Other Standard Manual Therapy
This intervention consists of six 40-minute sessions over eight weeks, matching the experimental group in duration, frequency, and clinical environment. It includes suboccipital inhibition, cervical traction, segmental vertebral mobilization, and temporomandibular joint decompression techniques. No ocular or visual system intervention is performed. The purpose is to serve as an active control for the cranio-cervical component of the treatment.
Primary outcome measures
- Visual Analog Scale (VAS) [Time frame: Baseline (pre-intervention, prior to the first treatment session) and immediately after each treatment session, through study completion.]
- Score obtained from the Craniofacial Pain and Disability Inventory (CF-PDI) [Time frame: Baseline (pre-intervention, prior to the first treatment session) and immediately after completion of the final treatment session.]
- Score obtained from the Migraine-Specific Quality of Life Questionnaire (MSQ) [Time frame: Baseline (pre-intervention, prior to the first treatment session) and immediately after completion of the final treatment session.]
- Score obtained from the Short Form-36 Health Survey (SF-36) [Time frame: Baseline (pre-intervention, prior to the first treatment session) and immediately after completion of the final treatment session.]
- Score obtained from the Migraine Disability Assessment Questionnaire (MIDAS) [Time frame: Baseline (pre-intervention, prior to the first treatment session) and immediately after completion of the final treatment session.]
- Score obtained from the Headache Impact Test (HIT-6) [Time frame: Baseline (pre-intervention, prior to the first treatment session) and immediately after completion of the final treatment session.]
Secondary outcome measures (12)
- Cervical Range of Motion - Flexion and Extension [Time frame: before first session and immediately after each of the 6 treatment sessions]
- Cervical Range of Motion - Right and Left Lateral Flexion [Time frame: before first session and immediately after each of the 6 treatment sessions]
- Cervical Range of Motion - Right and Left Rotation [Time frame: before first session and immediately after each of the 6 treatment sessions]
- Cranio-Cervical Flexion Test - Activation Score (AS) [Time frame: before first session and immediately after each of the 6 treatment sessions]
- Cranio-Cervical Flexion Test - Performance Index (PI) [Time frame: Baseline (before first session) and immediately after each of the 6 treatment sessions.]
- Head Postural Deviation in Neutral Standing Position [Time frame: before first session and immediately after each of the 6 treatment sessions]
- Pain Sensation in Each Gaze Position [Time frame: before first session and immediately after each of the 6 treatment sessions]
- Ocular Motility Assessment [Time frame: Before first session and immediately after each of the 6 treatment sessions]
- Modulation of Ocular Motility After Head Postural Correction in Standing Position [Time frame: Before first session and immediately after each of the 6 treatment sessions]
- Thorington test for Heterophoria [Time frame: Baseline (pre-intervention, prior to the first treatment session) and immediately after completion of the final treatment session.]
- Alternate Cover Test with Prism Bar for Oculomotor Deviation [Time frame: Baseline (pre-intervention, prior to the first treatment session) and immediately after completion of the final treatment session.]
- Fusional Vergence Amplitude (Positive and Negative) [Time frame: Baseline (pre-intervention, prior to the first treatment session) and immediately after completion of the final treatment session.]
Eligibility criteria
Inclusion criteria
- Being of legal age.
- Having a medical diagnosis of migraine without aura established by a neurologist, according to the criteria of the ICHD-III
- Having been diagnosed with migraine for at least one year and experiencing at least one attack per month.
- Having been prescribed a specific pharmacological treatment by a specialist physician for at least 6 months.
- Participants must attend all assessments with their habitual optical correction fully updated (glasses or contact lenses), ensuring that any refractive error is appropriately corrected.
- Presenting symptoms in the oculomotor system, as detailed in the participant information sheet.
Exclusion criteria
- Pregnancy or breastfeeding.
- Receiving any other type of physiotherapeutic treatment at the time of the intervention.
- Presenting any of the following conditions: chronic respiratory, cardiovascular, and/or musculoskeletal diseases such as polyarthritis, rheumatic muscle inflammation, osteoporosis, or osteoarthritis; other types of headache, other neurological diseases, oncological processes, cognitive, emotional, or psychological disorders; previous surgical interventions or trauma in the cervical region; or diseases specific to the oculomotor system.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Spain · 1 center
- Universidad from Sevilla — Seville
Identifiers
NCT: NCT07254598 · ECAOJO