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临床试验/NCT06871852
NCT06871852Enrolling By Invitation不适用

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

Bandırma Onyedi Eylül University1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2025年2月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
54
试验地点
1
主要终点
The Migraine Disability Assessment (MIDAS)

研究概览

简要总结

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.

详细描述

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.

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
None

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

  • •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

排除标准

  • •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)

研究组 & 干预措施

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.

干预措施: a video-based physiotherapy and exercise program. (Other)

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.

干预措施: brochure-based physiotherapy and exercise program. (Other)

control group

No Intervention

No exercise/training will be given to the control group.

结局指标

主要结局

The Migraine Disability Assessment (MIDAS)

时间窗: 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)

时间窗: 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.

次要结局

  • The Neck Disability Index (NDI)(Baseline- after 3 months)
  • The Short Form-12 (SF-12)(baseline - after 3 months)
  • The Exercise Adherence Rating Scale (EARS)(baseline - after 3 months)

研究者

发起方
Bandırma Onyedi Eylül University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gulhan Yilmaz Gokmen

Assoc. Prof.

Bandırma Onyedi Eylül University

研究点 (1)

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