Efficacy of Myotensive Techniques Applied to the Extraocular Muscles as an Adjunct to Manual Therapy in the Treatment of Migraine Without Aura
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Visual Analog Scale (VAS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Visual Analog Scale (VAS)
时间窗: Baseline (pre-intervention, prior to the first treatment session) and immediately after each treatment session, through study completion.
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.
Score obtained from the Craniofacial Pain and Disability Inventory (CF-PDI)
时间窗: Baseline (pre-intervention, prior to the first treatment session) and immediately after completion of the final treatment session.
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
Score obtained from the Migraine-Specific Quality of Life Questionnaire (MSQ)
时间窗: Baseline (pre-intervention, prior to the first treatment session) and immediately after completion of the final treatment session.
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
Score obtained from the Short Form-36 Health Survey (SF-36)
时间窗: Baseline (pre-intervention, prior to the first treatment session) and immediately after completion of the final treatment session.
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
Score obtained from the Migraine Disability Assessment Questionnaire (MIDAS)
时间窗: Baseline (pre-intervention, prior to the first treatment session) and immediately after completion of the final treatment session.
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.
Score obtained from the Headache Impact Test (HIT-6)
时间窗: Baseline (pre-intervention, prior to the first treatment session) and immediately after completion of the final treatment session.
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.
次要结局
- Cervical Range of Motion - Flexion and Extension(before first session and immediately after each of the 6 treatment sessions)
- Cervical Range of Motion - Right and Left Lateral Flexion(before first session and immediately after each of the 6 treatment sessions)
- Cervical Range of Motion - Right and Left Rotation(before first session and immediately after each of the 6 treatment sessions)
- Cranio-Cervical Flexion Test - Activation Score (AS)(before first session and immediately after each of the 6 treatment sessions)
- Cranio-Cervical Flexion Test - Performance Index (PI)(Baseline (before first session) and immediately after each of the 6 treatment sessions.)
- Head Postural Deviation in Neutral Standing Position(before first session and immediately after each of the 6 treatment sessions)
- Pain Sensation in Each Gaze Position(before first session and immediately after each of the 6 treatment sessions)
- Ocular Motility Assessment(Before first session and immediately after each of the 6 treatment sessions)
- Modulation of Ocular Motility After Head Postural Correction in Standing Position(Before first session and immediately after each of the 6 treatment sessions)
- Thorington test for Heterophoria(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(Baseline (pre-intervention, prior to the first treatment session) and immediately after completion of the final treatment session.)
- Fusional Vergence Amplitude (Positive and Negative)(Baseline (pre-intervention, prior to the first treatment session) and immediately after completion of the final treatment session.)
- Vertical Fusional Vergence (VV)(Baseline (pre-intervention, prior to the first treatment session) and immediately after completion of the final treatment session.)
- Vergence Facility (VF)(Baseline (pre-intervention, prior to the first treatment session) and immediately after completion of the final treatment session.)
研究者
Dr. María de la Casa Almeida
PhD, Physiotherapist, University of Seville.
Facultad de Enfermería, Fisioterapia y Podología (FEFP)