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Набор по приглашению NCT06871852

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

Без фазы С лечением Migraine Exercise

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: a video-based physiotherapy and exercise program., brochure-based physiotherapy and exercise program..
Кому может быть актуально
Состояния в реестре: Migraine, Exercise. Базовые параметры: 18 лет — 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Turkey (Türkiye)
Следующий шаг
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Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Другое 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.
  • Другое 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 re

Первичные конечные точки

  • The Migraine Disability Assessment (MIDAS) [Срок оценки: baseline - after 3 months]
  • The Migraine-Specific Cognitive Assessment (Mig-SCog) [Срок оценки: baseline - after 3 months]
Вторичные конечные точки (3)
  • The Neck Disability Index (NDI) [Срок оценки: Baseline- after 3 months]
  • The Short Form-12 (SF-12) [Срок оценки: baseline - after 3 months]
  • The Exercise Adherence Rating Scale (EARS) [Срок оценки: baseline - after 3 months]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Turkey (Türkiye) · 1 центр
  • Bandirma Onyedi Eylul University — Bandırma

Идентификаторы

NCT: NCT06871852 · 2024-292

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗