Clinical trial NCT06871852: The Effect of a Video-Based Exercise Program on Migraine Symptoms
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
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Migraine
Exercise
Keywords: migraine
exercise
video-based
telerehabilitation
Lead sponsor: Bandırma Onyedi Eylül University
Sponsor class: OTHER
First posted: 2025-03-12
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled study (3 group)
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: The Migraine Disability Assessment (MIDAS)
timeFrame: baseline - after 3 months
measure: The Migraine-Specific Cognitive Assessment (Mig-SCog)
timeFrame: baseline - after 3 months
Secondary outcomes:
measure: The Neck Disability Index (NDI)
timeFrame: Baseline- after 3 months
measure: The Short Form-12 (SF-12)
timeFrame: baseline - after 3 months
measure: The Exercise Adherence Rating Scale (EARS)
timeFrame: baseline - after 3 months
Other outcomes:
Locations:
city: Bandirma
country: Turkey
facility: Bandirma Onyedi Eylul University
state: Balıkesir
Study officials:
References: