Myotensive Extraocular Muscle Techniques Added to Manual Therapy for Migraine Without Aura

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorFacultad de Enfermería, Fisioterapia y Podología (FEFP)

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Myotensive Extraocular Muscle Techniques + Manual Therapy

    Other intervention

    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.

  • Standard Manual Therapy

    Other intervention

    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.

Treatment groups

84 Participants
are divided into 2 treatment groups
Group A: Myotensive Extraocular Muscle Techniques + Manual TherapyExperimental treatment 1 intervention
Group B: Standard Manual TherapyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline (pre-intervention, prior to the first treatment session) and immediately after each treatment session, through study completion.
2

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

Time frame
Baseline (pre-intervention, prior to the first treatment session) and immediately after completion of the final treatment session.
3

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

Time frame
Baseline (pre-intervention, prior to the first treatment session) and immediately after completion of the final treatment session.
4

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

Time frame
Baseline (pre-intervention, prior to the first treatment session) and immediately after completion of the final treatment session.

Secondary outcomes

1

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.

Time frame
before first session and immediately after each of the 6 treatment sessions
2

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.

Time frame
before first session and immediately after each of the 6 treatment sessions
3

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

Time frame
before first session and immediately after each of the 6 treatment sessions
4

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.

Time frame
before first session and immediately after each of the 6 treatment sessions

Other outcomes

1

Participant's Sex

This qualitative nominal variable records the sex of each participant as registered in the electronic clinical history.

Time frame
Baseline (at enrollment, prior to any intervention)
2

Participant's Age

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

Time frame
Baseline (at enrollment, prior to any intervention).
3

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.

Time frame
Baseline (at enrollment, prior to any intervention).
4

Medication use

This nominal qualitative variable records the type of medication taken to reduce migraine symptoms, categorized as follows: * Analgesic (e.g., paracetamol/acetaminophen) * Specific anti-migraine medication (triptans) * Non-steroidal anti-inflammatory drugs (NSAIDs) * Antiemetic * Other medications

Time frame
Daily throughout the 8-week intervention period

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