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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Myotensive Extraocular Muscle Techniques + Manual Therapy | Experimental | Cranio-Cervical Manual Therapy Combined with Extraocular Myotensive Techniques |
|
| Standard Manual Therapy | Active Comparator | Standard Cranio-Cervical Manual Therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Myotensive Extraocular Muscle Techniques + Manual Therapy | Other | 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 movement directions. The goal is to modulate extraocular muscle tone, optimize the cervico-ocular proprioceptive relationship, and reduce migraine-related dysfunctions. |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale (VAS) | This continuous quantitative variable assesses the intensity of pain experienced by the patient. The VAS consists of a 10 cm horizontal line whose endpoints are anchored by the expressions "no pain" on the left end and "worst pain imaginable" on the right end. The patient is asked to mark the point along this line that best represents their subjective perception of pain at that moment, and the score is obtained by measuring in centimeters from the left end to the mark made. | 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) | This discrete quantitative variable, originally named the Craniofacial Pain and Disability Inventory (CF-PDI), is a questionnaire specifically designed to assess pain and disability in patients suffering from craniofacial pain, such as headaches, temporomandibular disorders, and related conditions. The aim of the questionnaire is to evaluate the severity of craniofacial pain and its impact on patients' functional, emotional, and social activities. It is structured into items grouped into four dimensions: the impact on daily activities, work, interpersonal relationships, and emotional state. Each item is rated on a 5-point Likert scale ranging from 0 to 4, where 0 indicates minimal impact and 4 indicates maximum perceived impact in each dimension. The total score can reach up to 84 points, with higher scores reflecting greater levels of disability and impact of craniofacial pain on the patient's life. This tool has demonstrated excellent psychometric properties, with high reliability i | 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) | This continuous quantitative variable corresponds to a tool used to assess the impact of migraine on patients' quality of life. The MSQ includes 14 items that explore the frequency and intensity of migraine episodes and their impact on work activities, social relationships, emotional well-being, and overall health status. Responses are rated using a Likert-type scale. The questionnaire is divided into subscales corresponding to different domains of life affected by migraine: physical functioning, emotional functioning, and social functioning. The total score is obtained by summing the subscale scores. Each of the 14 items is rated on a 6-point Likert scale ranging from 1 = "all the time" to 6 = "never," thus evaluating how frequently migraine interferes with different aspects of the patient's life. To facilitate interpretation and standardization, raw scores from the MSQ are transformed to a standardized 0-100 scale. This transformation is achieved by subtracting the minimum possible |
| Measure | Description | Time Frame |
|---|---|---|
| Cervical Range of Motion - Flexion and Extension | This continuous quantitative variable will be measured using a gravity goniometer, expressed in degrees. Participants will be asked to actively perform flexion and extension movements. Three measurements will be taken, and the mean value will be recorded. The gravity goniometer has demonstrated validity and reliability for assessing cervical range of motion, with excellent intra-rater reliability (ICC > 0.85) according to Youdas et al., and good concurrent validity when compared to three-dimensional systems (differences < 5°). It also shows adequate inter-rater reliability when standardized protocols are followed. |
| Measure | Description | Time Frame |
|---|---|---|
| Participant's Sex | This qualitative nominal variable records the sex of each participant as registered in the electronic clinical history. | Baseline (at enrollment, prior to any intervention) |
| Participant's Age |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Juan Sanchez Tejedor, PT | Contact | *34671265717 | juasantej@alum.us.es | |
| María De la casa Almeida, PhD, PT | Contact | +34 615617103 | mcasa@us.es |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidad from Sevilla | Seville | Andalusia | 41009 | Spain |
Individual participant data (IPD) will not be shared because this study involves personal health information collected under strict confidentiality according to the General Data Protection Regulation (EU) and the Spanish Data Protection Law (LOPDGDD). Only aggregated and anonymized results will be published in scientific journals and repositories.
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| ID | Term |
|---|---|
| D020326 | Migraine without Aura |
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D026201 | Musculoskeletal Manipulations |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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The study is considered double-blind because two levels of blinding are implemented:
Blinding of participants:
Subjects will not know whether they are receiving the experimental intervention (cranio-cervical manual therapy combined with extraocular myotensive techniques) or the control intervention (standard cranio-cervical manual therapy only). To achieve this, both interventions will be applied under identical conditions of duration, frequency, environment, and therapist-patient contact, so that the subjective treatment experience remains indistinguishable and participants cannot identify which group they belong to.
Blinding of outcome assessors:
The physiotherapists and optometrists responsible for performing pre- and post-intervention measurements will not know the participants' group allocation. Data will be coded and analyzed using numerical identifiers to ensure objectivity in the evaluation of results.
|
| Standard Manual Therapy | Other | 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. |
|
| 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) | This continuous quantitative variable is used to measure health-related quality of life, encompassing multiple aspects of physical and mental well-being. The SF-36 consists of 36 items divided into eight subscales evaluating different dimensions of health: Physical Functioning (PF), Social Functioning (SF), Role Emotional (RE), Vitality (VT), Mental Health (MH), Bodily Pain (BP), General Health (GH), and Physical Health (PH). Each subscale is scored from 0 to 100, where higher scores indicate better quality of life in that particular domain. Subscale scores can be analyzed individually or combined to generate an overall quality of life index. The SF-36 was developed by Ware et al. (1992) and adapted and validated into Spanish as part of the international IQOLA project by Vilagut et al. The SF-36 has demonstrated excellent reliability and validity across diverse populations and clinical contexts. It shows high internal consistency, with Cronbach's alpha coefficients generally above 0.8 | 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) | This continuous quantitative variable is a self-administered tool designed to evaluate the impact of migraine on patients' daily activities over the past three months. It consists of five questions assessing the number of days lost in work, household, and social activities due to migraine. The total score is obtained by summing responses to these five questions and is classified into four disability grades: 0-5 points: little or no disability 6-10 points: mild disability 11-20 points: moderate disability ≥21 points: severe disability Additionally, the questionnaire includes two supplemental questions that gather information on the frequency of migraine episodes and the average pain intensity on a 0-10 scale. The MIDAS has shown moderately high test-retest reliability and good convergent validity. | 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) | This continuous quantitative variable consists of a questionnaire with six items assessing the impact of headaches across various aspects of a patient's life, including pain, functional limitation, fatigue, cognition, and emotional status, providing a global overview of headache burden. Each item is rated on a 5-point frequency scale: never (6 points), rarely (8 points), sometimes (10 points), very often (11 points), and always (13 points). The total score ranges from 36 to 78 and is interpreted as follows: ≤49: little or no impact 50-55: some impact 56-59: substantial impact ≥60: severe impact The HIT-6 has demonstrated excellent psychometric properties, with internal consistency (Cronbach's alpha) ranging from 0.78 to 0.90 across studies, strong validity through correlations with other migraine assessment scales such as MIDAS and SF-36, and high reproducibility, with test-retest coefficients above 0.80. | Baseline (pre-intervention, prior to the first treatment session) and immediately after completion of the final treatment session. |
| before first session and immediately after each of the 6 treatment sessions |
| Cervical Range of Motion - Right and Left Lateral Flexion | This continuous quantitative variable will be measured in degrees using a gravity goniometer. Participants will be asked to actively perform right (RSB) and left (LSB) lateral flexion movements three times each, and the mean value will be calculated. | before first session and immediately after each of the 6 treatment sessions |
| Cervical Range of Motion - Right and Left Rotation | This continuous quantitative variable will be measured in degrees using a gravity goniometer. Participants will be asked to actively perform right (RR) and left (LR) cervical rotation three times each, and the mean value will be obtained | before first session and immediately after each of the 6 treatment sessions |
| Cranio-Cervical Flexion Test - Activation Score (AS) | Assessed using the Cranio-Cervical Flexion Test (CCFT) with the Chattanooga Stabilizer™ pressure biofeedback device. The Activation Score reflects the highest pressure level (in mmHg) that the participant can achieve and maintain with correct deep cervical flexor activation and without recruitment of superficial musculature. | before first session and immediately after each of the 6 treatment sessions |
| Cranio-Cervical Flexion Test - Performance Index (PI) | Assessed using the Cranio-Cervical Flexion Test (CCFT) with the Chattanooga Stabilizer™ pressure biofeedback device. The Performance Index represents the product of the pressure level achieved and the duration maintained, providing a quantitative measure of deep cervical flexor endurance and control. | Baseline (before first session) and immediately after each of the 6 treatment sessions. |
| Head Postural Deviation in Neutral Standing Position | This categorical quantitative variable measures the spontaneous tilt or rotation of the head axis relative to the vertical plane in relaxed standing posture, while the participant fixates on a target 50 cm away at eye level. Measured with a gravity goniometer and categorized as:
| before first session and immediately after each of the 6 treatment sessions |
| Pain Sensation in Each Gaze Position | This dichotomous qualitative variable records the presence or absence of pain during eye movement or fixation in each of the nine gaze positions: primary gaze, dextroversion, levoversion, supraversion, infraversion, dextroelevation, levoelevation, dextrodepression, and levodepression. The examiner asks the participant to look at a target placed in each position for 4 seconds, noting any painful sensation. This helps detect patterns of oculomotor dysfunction and serves as an indirect clinical indicator of tension or hypertonicity in extraocular muscles | before first session and immediately after each of the 6 treatment sessions |
| Ocular Motility Assessment | This ordinal qualitative variable assesses whether the participant can perform complete and unrestricted eye movements in all nine gaze directions. The evaluation follows a standardized clinical observation using the "H-test" or star pattern, with a pen, pointer, or finger moved at approximately 50 cm distance. Each gaze direction is categorized as:
| Before first session and immediately after each of the 6 treatment sessions |
| Modulation of Ocular Motility After Head Postural Correction in Standing Position | This dichotomous ordinal qualitative variable records whether there is a symptomatic improvement (pain reduction and/or increased ocular mobility) after manual correction of head posture in neutral standing. Categorized as:
| Before first session and immediately after each of the 6 treatment sessions |
| Thorington test for Heterophoria | The Thorington test will be used to measure latent ocular deviation, expressed in prism diopters (∆), through optical dissociation with a Maddox rod and direct reading on a calibrated scale. This method provides high intra-examiner, inter-examiner, and test-retest reliability, and is sensitive to small changes following an intervention. Its internal validity relies on strict standardization of distance, illumination, rod orientation, and accommodative demand, while its external validity is supported by its widespread use as a reference test in binocular vision research. Due to its consistency, reproducibility, and clinical relevance, the Thorington test is considered an appropriate and reliable variable for use in a clinical trial. | 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 | This continuous quantitative variable quantifies heterophoria in prism diopters (Δ), positive for exophoria and negative for esophoria, by neutralizing ocular recovery movement with increasing prism strength. Normal values: ≤4Δ at distance and ≤6Δ at near (horizontal); ≤1Δ (vertical). Reliability: moderate to high (ICC 0.65-0.90), good concurrent validity with the Von Graefe test. | Baseline (pre-intervention, prior to the first treatment session) and immediately after completion of the final treatment session. |
| Fusional Vergence Amplitude (Positive and Negative) | Continuous quantitative variable that measures the ability of the visual system to maintain binocular fusion in response to retinal disparity stimuli induced by prisms.
Normal ranges:
| Baseline (pre-intervention, prior to the first treatment session) and immediately after completion of the final treatment session. |
| Vertical Fusional Vergence (VV) | Continuous quantitative variable representing the visual system's ability to maintain vertical alignment under dissociative stimuli using base-up (BU) and base-down (BD) prisms. Normal values: break 2-3Δ, recovery ≥1.5Δ, symmetrical between eyes. Test-retest reliability: high, with strong clinical validity. | Baseline (pre-intervention, prior to the first treatment session) and immediately after completion of the final treatment session. |
| Vergence Facility (VF) | Continuous quantitative variable evaluating the efficiency of alternating between convergence and divergence. Measured in cycles per minute (cpm) using a prism combination of 3Δ base-in (BI) and 12Δ base-out (BO). Normal values: ≥12 cpm (near vision), ≥10 cpm (distance). Test-retest reliability: ICC > 0.75; sensitive to improvements after visual therapy. | Baseline (pre-intervention, prior to the first treatment session) and immediately after completion of the final treatment session. |
This continuous quantitative variable records age in full years, calculated from the participant's date of birth. If required for specific statistical analyses, this variable may be categorized into age ranges to explore possible differences in migraine frequency, intensity, or characteristics across age groups
| Baseline (at enrollment, prior to any intervention). |
| History of Migraine | This nominal qualitative variable indicates whether a family history of migraine is present (Yes/No). For positive cases, the degree of kinship of the affected relative will be specified. | Baseline (at enrollment, prior to any intervention). |
| Medication use | This nominal qualitative variable records the type of medication taken to reduce migraine symptoms, categorized as follows:
| Daily throughout the 8-week intervention period |
| Amount of Medication Consumed | This continuous quantitative variable records the quantity of medication consumed during a migraine attack, expressed in milligrams (mg) or number of doses per day. | Daily throughout the 8-week intervention period |
| Migraine Attack Intensity | This ordinal quantitative variable records the subjective intensity of each migraine attack using a 10-point numeric rating scale, where 1 = minimal pain and 10 = maximum pain experienced. | Daily throughout the 8-week intervention period |
| Presence of Prodrome Prior to the Attack | This dichotomous qualitative variable records the presence (Yes/No) of prodromal symptoms prior to the onset of a migraine episode, as well as their type when present. | Daily throughout the 8-week intervention period |
| Dietary Factors | This dichotomous nominal qualitative variable records whether the participant consumed any of the following potential dietary triggers within the 24 hours prior to symptom onset: chocolate, dairy products, monosodium glutamate, caffeine, and/or histamine-rich foods. Participants receive an informational sheet (Annex 2) describing which foods to avoid or monitor. | Daily throughout the 8-week intervention period |
| Water Intake | This continuous quantitative variable records the approximate amount of water consumed daily during participation in the study, categorized as:
| Daily throughout the 8-week intervention period |
| Alcohol and/or Substance Use | This dichotomous quantitative variable records whether the participant consumed alcohol or other substances within the 24 hours prior to the migraine episode (Yes/No). When "Yes," the type and quantity consumed will be specified | Daily throughout the 8-week intervention period |
| Physical Activity Prior to Migraine Onset | This ordinal qualitative variable records whether the participant engaged in physical activity within the 24 hours preceding migraine onset. When physical activity is present, participants may optionally provide a brief description, including perceived intensity and activity type, to help contextualize the potential relationship with migraine triggers. | Daily throughout the 8-week intervention period |
| Moderate/Intense Occupational Activity | This nominal quantitative variable records whether the participant performed light, moderate, or vigorous work-related activity during the 24 hours prior to migraine onset, classified according to the World Health Organization (WHO) guidelines on physical activity intensity levels | Daily throughout the 8-week intervention period |
| D009422 | Nervous System Diseases |