The Effect of a Video-Based Exercise Program on Migraine Symptoms

Not Applicable

• Conditions: Migraine; Exercise

• Registration Number: NCT06871852
• Lead Sponsor: Bandırma Onyedi Eylül University

Brief Summary

The aim of this study is to investigate the effects of a video- and brochure-based physiotherapy and exercise program on migraine symptoms, neck disability, cognitive functions, and quality of life in patients with migraine.

Hypotheses H1: The video-based physiotherapy and exercise program has an effect on migraine symptoms in patients with migraine.

H2: The video-based physiotherapy and exercise program has an effect on neck disability in patients with migraine.

H3: The video-based physiotherapy and exercise program has an effect on cognitive functions in patients with migraine.

H4: The video-based physiotherapy and exercise program has an effect on quality of life in patients with migraine.

H5: The brochure-based physiotherapy and exercise program has an effect on migraine symptoms in patients with migraine.

H6: The brochure-based physiotherapy and exercise program has an effect on neck disability in patients with migraine.

H7: The brochure-based physiotherapy and exercise program has an effect on cognitive functions in patients with migraine.

H8: The brochure-based physiotherapy and exercise program has an effect on quality of life in patients with migraine.

Participants diagnosed with migraine who meet the inclusion criteria and voluntarily agree to participate in the study will be randomly assigned to three groups using block randomization. The study will be conducted online.

Before the intervention, participants will be asked to complete the Demographic Information Form, Migraine Disability Assessment (MIDAS) Questionnaire, Mig-Scog Questionnaire, Neck Disability Index (NDI), and SF-12 Quality of Life Questionnaire via an online Google Form.

Group 1 will receive a video-based physiotherapy and exercise program. Group 2 will receive a brochure-based physiotherapy and exercise program. Group 3 will serve as the control group. Participants in the intervention groups will be instructed to perform the exercises three times per week for 12 weeks, with one session per day, consisting of 10 repetitions for each exercise.

At the end of the 12th week, all assessments will be repeated to evaluate the effects of the intervention.

Detailed Description

Migraine is commonly treated with medication; however, some patients are unable to tolerate acute and/or prophylactic medications due to side effects or contraindications associated with comorbid conditions such as myocardial disorders or asthma. The prevalence of neck pain is high among individuals with migraine, and various dysfunctions in the cervical region have been observed, including increased sensitivity of the cranio-cervical muscles, reduced force production in cervical extensor muscles, impaired performance of deep flexor muscles, decreased cervical range of motion (ROM), and hypomobility of the upper cervical segments (C1-C2).

There is increasing evidence supporting the role of physiotherapy in migraine treatment, with two primary approaches currently proposed for patient management: addressing musculoskeletal dysfunctions in the cranio-cervical region and managing postural control impairments. Furthermore, nearly 80% of migraine patients report experiencing some degree of neck pain during the migraine cycle. The prevalence of neck pain exceeds that of nausea, which is considered a diagnostic criterion for migraine. The presence of neck pain is associated with a more severe clinical presentation of migraine and may even reduce responsiveness to pharmacological treatment, thereby increasing the overall burden of the condition. Additionally, the perception of muscle tension in the neck is linked to more intense migraine attacks.

To facilitate patient adherence to exercise programs, videos and brochures are commonly used. Videos are easy to understand and can effectively simulate live demonstrations, while brochures can be tailored and customized to meet individual patient needs. Video- and brochure-based programs offer an alternative for patients who face challenges in attending in-person treatment sessions, such as those with conflicting work schedules or other barriers to participation. A review of the literature reveals a lack of studies investigating the efficacy of video- and brochure-based physiotherapy and exercise programs for migraine management.

Existing studies have primarily focused on either a single type of exercise intervention or physiotherapy techniques applied exclusively by a physiotherapist. This study aims to include exercises that migraine patients can perform independently, along with physiotherapy techniques and guidance on essential considerations, triggering factors, and recommendations for migraine management. Since migraine patients often prefer to remain indoors during episodes, accessing video-based instruction or brochures in a comfortable environment may facilitate treatment adherence.

The objective of this study is to examine the effects of a video- and brochure-based self-administered physiotherapy and exercise program on migraine symptoms, neck disability, cognitive functions, and quality of life in individuals with migraine.

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-11
• Study Start: 2025-02-20
• Study First Submitted QC: 2025-03-11
• Last Update Submitted: 2025-03-11
• Study First Posted: 2025-03-12
• Last Update Posted: 2025-03-12
• Primary Completion: 2025-06
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

1. Migraine has been diagnosed by a specialist physician
2. Between the ages of 18 and 65
3. Volunteering to participate in the study
4. To be able to answer surveys sent from a smart phone or computer

Exclusion Criteria

1. Having secondary diseases such as morbid obesity, blood pressure, diabetes
2. Any other neurological or psychiatric disorder
3. Severe cervical disc herniation or radiculopathy
4. Receiving any other treatment for migraine during the study (except medication)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The Migraine Disability Assessment (MIDAS)	baseline - after 3 months	The Migraine Disability Assessment (MIDAS) questionnaire is a brief, self-administered tool designed to measure headache-related disability over a three-month period. It consists of five items that assess the number of days, in the past 3 months, of activity limitations due to migraine. Higher scores indicate greater disability. The MIDAS questionnaire has been shown to be internally consistent, highly reliable, valid, and correlates with physicians' clinical judgment. Consequently, it is widely used in clinical research as a standard assessment tool.
The Migraine-Specific Cognitive Assessment (Mig-SCog)	baseline - after 3 months	The Migraine-Specific Cognitive Assessment (Mig-SCog) is a self-administered questionnaire developed in 2011 by Gil-Gouveia and colleagues to assess and monitor cognitive symptoms during migraine attacks. The scale consists of nine Likert-type items, each scored from 0 to 2, with a total score ranging from 0 to 18; higher scores indicate a greater frequency of cognitive symptoms. The first three items assess attention, processing speed, and orientation; items four and five evaluate planning and attention; items six and seven pertain to language; and items eight and nine focus on naming. Thus, the Mig-SCog primarily examines executive functions (attention, planning, and orientation) and language (naming and verbal fluency), which are the areas most commonly reported as problematic by patients during migraine attacks. A high Mig-SCog score indicates a high frequency of cognitive symptoms.

Secondary Outcome Measures

Name	Time	Method
The Neck Disability Index (NDI)	Baseline- after 3 months	The Neck Disability Index (NDI) is a self-report questionnaire designed to assess how neck pain affects a patient's daily life. Developed in 1989 by Howard Vernon, it is widely used in both clinical and research settings. The NDI consists of 10 items, each scored on a scale from 0 to 5, with higher scores indicating greater disability. The total score can range from 0 to 50 and is often expressed as a percentage. Interpretation of the scores is as follows: 0-4: No disability 5-14: Mild disability 15-24: Moderate disability 25-34: Severe disability 35-50: Complete disability The NDI has been shown to have good reliability and validity in various studies. A change of 5 points is considered the minimal clinically important difference, indicating a meaningful change in a patient's condition. The questionnaire typically takes between 3 to 7.8 minutes to complete.
The Short Form-12 (SF-12)	baseline - after 3 months	The Short Form-12 (SF-12) is a concise health survey derived from the SF-36, designed to assess overall health status efficiently. Developed in 1995, the SF-12 has been validated in various languages, including Turkish. Studies have found that the SF-12's psychometric properties are comparable to those of the SF-36. The Physical Component Score (PCS) is derived from subdomains such as general health, physical functioning, role-physical, and bodily pain, while the Mental Component Score (MCS) is obtained from subdomains including social functioning, role-emotional, mental health, and vitality.
The Exercise Adherence Rating Scale (EARS)	baseline - after 3 months	The Exercise Adherence Rating Scale (EARS) is a valid and reliable tool developed by Newman and colleagues to assess exercise adherence behavior. It provides a simple, standardized, and reliable evaluation of adherence to prescribed home exercises, facilitating the development and assessment of interventions that promote long-term self-management for both the prevention and treatment of chronic conditions. The EARS consists of three sections: Section A: Comprising six items that can be adapted to personal needs; this section is not included in the scale scoring.; Section B: The core part of the scale, which cannot be adapted to personal needs, describes how the recommended home exercises are performed.; Section C: Evaluates the reasons for adherence or non-adherence to the recommended home exercises.; The items of the measurement tool are scored between 1 and 4. Scores of 1 and 2 indicate irrelevance, 3 and 4 indicate interest. A high EARS score indicates good compliance with exercise.

Trial Locations

Locations (1)

Bandirma Onyedi Eylul University; 🇹🇷 Bandirma, Balıkesir, Turkey