MigraineNCT06871852
The Effect of a Video-Based Exercise Program on Migraine Symptoms
A study testing a video-based physiotherapy and exercise program. and brochure-based physiotherapy and exercise program. in people with Migraine and Exercise, run by Bandırma Onyedi Eylül University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- What is being tested?
- a video-based physiotherapy and exercise program. and brochure-based physiotherapy and exercise program.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Feb 2025to Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Migraine has been diagnosed by a specialist physician
- Between the ages of 18 and 65
- Volunteering to participate in the study
- To be able to answer surveys sent from a smart phone or computer
Who cannot join
- Having secondary diseases such as morbid obesity, blood pressure, diabetes
- Any other neurological or psychiatric disorder
- Severe cervical disc herniation or radiculopathy
- Receiving any other treatment for migraine during the study (except medication)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Bandirma Onyedi Eylul University
Bandırma, Balıkesir, 10200
About this study
Official title: The Effect 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: a Randomized Controlled Trial
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.
Read more
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.
Read the 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.
- Being tested
- a video-based physiotherapy and exercise program., brochure-based physiotherapy and exercise program.
- Keywords
- migraine, exercise, video-based, telerehabilitation
- Medical subject headings
- Migraine Disorders, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
a video-based physiotherapy and exercise program.Other
Video-Based Intervention Group: Participants in this group will receive videos detailing migraine triggers, precautionary measures, and a physiotherapy and exercise program. Each exercise will be thoroughly explained by a physiotherapist in the videos, enabling participants to perform the exercises correctly by following the verbal and visual instructions.
brochure-based physiotherapy and exercise program.Other
Brochure-Based Intervention Group: Participants in this group will be provided with brochures that include information on migraine triggers, precautionary measures, and rehabilitation exercises accompanied by visual aids. The exercises will be detailed with written instructions and illustrations.
Exercise Program: The exercise program will include self-massage techniques for specific muscle groups, self C1-C2 joint mobilization, cervical region exercises, cognitive exercises, and progressive relaxation exercises for the back and face.
| Study group | Role | What they receive |
|---|---|---|
| Video-Based Intervention Group | Experimental | Group 1 - video-based physiotherapy and exercise program: Video-Based Intervention Group: Participants in this group will receive videos detailing migraine triggers, precautionary measures, and a physiotherapy and exercise program. Each exercise will be thoroughly explained by a physiotherapist in the videos, enabling participants to perform the exercises correctly by following the verbal and visual instructions. To ensure proper technique, additional video recordings will be provided to address participants' questions upon request. Receives: Other: a video-based physiotherapy and exercise program. |
| Brochure-Based Intervention Group | Experimental | Brochure-Based Intervention Group: Participants in this group will be provided with brochures that include information on migraine triggers, precautionary measures, and rehabilitation exercises accompanied by visual aids. The exercises will be detailed with written instructions and illustrations. Receives: Other: brochure-based physiotherapy and exercise program. |
| control group | No intervention | No exercise/training will be given to the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Migraine Disability Assessment (MIDAS)
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.
Measured: baseline - after 3 months
The Migraine-Specific Cognitive Assessment (Mig-SCog)
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.
Measured: baseline - after 3 months
Secondary outcomes (3)
The Neck Disability Index (NDI)
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.
Measured: Baseline- after 3 months
The Short Form-12 (SF-12)
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.
Measured: baseline - after 3 months
The Exercise Adherence Rating Scale (EARS)
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.
Measured: baseline - after 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2025
- Study start20 Feb 2025
- Primary completionJun 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled study (3 group)
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bandırma Onyedi Eylül University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gulhan Yilmaz Gokmen, Bandırma Onyedi Eylül University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06871852
- Sponsor's protocol ID
- 2024-292
- Status last verified
- Feb 2025
- First submitted
- 11 Feb 2025
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect 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: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06871852
- Acronym / sponsor ID
- 2024-292
- Keywords
- migraine, exercise, video-based, telerehabilitation
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Bandırma Onyedi Eylül UniversityUniversity, hospital or other
- Study start
- 20 Feb 2025 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 12 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- randomized controlled study (3 group)
| Arm | Type | Receives |
|---|---|---|
| Video-Based Intervention Group | Experimental | Other: a video-based physiotherapy and exercise program.Group 1 - video-based physiotherapy and exercise program: Video-Based Intervention Group: Participants in this group will receive videos detailing migraine triggers, precautionary measures, and a physiotherapy and exercise program. Each exercise will be thoroughly explained by a physiotherapist in the videos, enabling participants to perform the exercises correctly by following the verbal and visual instructions. To ensure proper technique, additional video recordings will be provided to address participants' questions upon request. |
| Brochure-Based Intervention Group | Experimental | Other: brochure-based physiotherapy and exercise program.Brochure-Based Intervention Group: Participants in this group will be provided with brochures that include information on migraine triggers, precautionary measures, and rehabilitation exercises accompanied by visual aids. The exercises will be detailed with written instructions and illustrations. |
| control group | No intervention | –No exercise/training will be given to the control group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Migraine has been diagnosed by a specialist physician
- Between the ages of 18 and 65
- Volunteering to participate in the study
- To be able to answer surveys sent from a smart phone or computer
Key exclusion criteria (4 listed)
- Having secondary diseases such as morbid obesity, blood pressure, diabetes
- Any other neurological or psychiatric disorder
- Severe cervical disc herniation or radiculopathy
- Receiving any other treatment for migraine during the study (except medication)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| a video-based physiotherapy and exercise program.Video-Based Intervention Group: Participants in this group will receive videos detailing migraine triggers, precautionary measures, and a physiotherapy and exercise program. Each exercise will be thoroughly explained by a physiotherapist in the videos, enabling participants to perform the exercises correctly by following the verbal and visual instructions. | Other | Video-Based Intervention Group |
| brochure-based physiotherapy and exercise program.Brochure-Based Intervention Group: Participants in this group will be provided with brochures that include information on migraine triggers, precautionary measures, and rehabilitation exercises accompanied by visual aids. The exercises will be detailed with written instructions and illustrations. Exercise Program: The exercise program will include self-massage techniques for specific muscle groups, self C1-C2 joint mobilization, cervical region exercises, cognitive exercises, and progressive relaxation exercises for the back and face. | Other | Brochure-Based Intervention Group |
Primary outcome
The Migraine Disability Assessment (MIDAS)
Time frame: 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)
Time frame: 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.
3 secondary outcomes
The Neck Disability Index (NDI)
Time frame: Baseline- after 3 months
The Short Form-12 (SF-12)
Time frame: baseline - after 3 months
The Exercise Adherence Rating Scale (EARS)
Time frame: baseline - after 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing a video-based physiotherapy and exercise program. and brochure-based physiotherapy and exercise program. in people with Migraine and Exercise, run by Bandırma Onyedi Eylül University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Migraine Disability Assessment (MIDAS) (time frame: baseline - after 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2025.